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Trial record 98 of 215 for:    Lamotrigine

Lamictal as Add-on Treatment for Bipolar I Disorder in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT00723450
Recruitment Status : Completed
First Posted : July 28, 2008
Results First Posted : June 4, 2014
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Bipolar Disorder
Intervention Drug: lamictal
Enrollment 301
Recruitment Details A total of 301 participants were enrolled in the study, of which 298 subjects took at least one dose of lamotrigine (LTG). One hundred and seventy three participants met stabilization criteria and entered the Randomized Phase.
Pre-assignment Details The study consisted of a 2-week Screening Phase, an 18-week Open-Label Phase, a 36-week Double-Blind Randomized Phase and a Taper and Follow-up Phase (up to 4 weeks depending on the dose the participant was taking at the last Open-Label or Randomized Phase visit), which was either open-label or double-blind depending on the phase of the study.
Arm/Group Title LTG: Open-Label Phase Placebo Lamotrigine
Hide Arm/Group Description Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks. Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks. Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Period Title: Open-Label Phase
Started 298 0 0
Completed 173 0 0
Not Completed 125 0 0
Reason Not Completed
Adverse Event             26             0             0
Lack of Efficacy             18             0             0
Protocol Violation             35             0             0
Lost to Follow-up             7             0             0
Physician Decision             2             0             0
Withdrawal by Subject             37             0             0
Period Title: Randomized Phase
Started 0 86 87
Completed 0 21 20
Not Completed 0 65 67
Reason Not Completed
Adverse Event             0             26             17
Lack of Efficacy             0             11             11
Protocol Violation             0             9             13
Lost to Follow-up             0             2             3
Physician Decision             0             3             1
Withdrawal by Subject             0             14             22
Arm/Group Title Placebo Lamotrigine Total
Hide Arm/Group Description Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks. Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks. Total of all reporting groups
Overall Number of Baseline Participants 86 87 173
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 87 participants 173 participants
13.5  (2.22) 13.4  (2.33) 13.5  (2.27)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 87 participants 173 participants
Female
39
  45.3%
33
  37.9%
72
  41.6%
Male
47
  54.7%
54
  62.1%
101
  58.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 87 participants 173 participants
African American/African Heritage 9 9 18
American Indian or Alaska Native 0 1 1
Asian - East Asian Heritage 1 0 1
White - Arabic/North African Heritage 1 0 1
White - White/Caucasian/European Heritage 71 71 142
Mixed Race 4 6 10
1.Primary Outcome
Title Time From Randomization to the Occurrence of a Bipolar Event (TOBE)
Hide Description TOBE was defined by the first prescription of any additional pharmacotherapy to treat bipolar symptoms, increasing the dose(s) of the participants conventional bipolar medication(s), treatment with electroconvulsive therapy, or moving the participant to a more restricted environment for observation, safety, or treatment; or participant withdrawal from the study due to a bipolar-related adverse event (AE) or serious adverse event (SAE); or participants withdrawal from the study due to lack of efficacy as defined by rating scale threshold scores. TOBE was calculated using a log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).
Time Frame From randomization until Week 36
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Hide Analysis Population Description
Randomized Intent-to-Treat (ITT) Population: all participants who were randomized to LTG or placebo and received at least one dose of investigational product.
Arm/Group Title Placebo Lamotrigine
Hide Arm/Group Description:
Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Overall Number of Participants Analyzed 86 87
Mean (Standard Error)
Unit of Measure: Days
Stratum: Depression, n=22,21 50  (3.8) 155  (14.7)
Stratum: Mania/Hypomania, n=36, 37 120  (12.2) 163  (12.2)
Stratum: Mixed Mood, n=28, 29 107  (13.8) 136  (15.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Lamotrigine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0717
Comments [Not Specified]
Method Log Rank
Comments A stratified log rank test was performed where the stratification factor was the index mood state at Screen visit.
2.Secondary Outcome
Title Time From Randomization to Withdrawal From the Study for Any Cause (TTW)
Hide Description The time from randomization to the withdrawal from study was analyzed. TTW was calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).
Time Frame From randomization until withdrawal from the study for any cause (up to Week 36)
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Hide Analysis Population Description
Randomized ITT Population
Arm/Group Title Placebo Lamotrigine
Hide Arm/Group Description:
Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Overall Number of Participants Analyzed 86 87
Mean (Standard Error)
Unit of Measure: Days
Stratum: Depression, n=22, 21 113  (21.4) 141  (20.0)
Stratum: Mania/Hypomania, n=36, 37 138  (17.3) 144  (15.6)
Stratum: Mixed Mood, n=28, 29 101  (15.7) 106  (16.3)
3.Secondary Outcome
Title Time From Randomization to Intervention for a Mood Episode (TIME)
Hide Description The time from randomization to the intervention for a mood episode (depression, mania/hypomania or mixed mood) was analyzed. TIME was calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).
Time Frame From randomization until intervention administered for a mood episode (up to Week 36)
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Hide Analysis Population Description
Randomized ITT Population
Arm/Group Title Placebo Lamotrigine
Hide Arm/Group Description:
Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Overall Number of Participants Analyzed 86 87
Mean (Standard Error)
Unit of Measure: Days
Stratum: Depression, n=22, 21 62  (5.2) 164  (12.7)
Stratum: Mania/Hypomania, n=36, 37 129  (11.7) 179  (10.8)
Stratum: Mixed Mood, n=28, 29 120  (13.7) 127  (12.0)
4.Secondary Outcome
Title Time From Randomization to Intervention for Depression (TIDep), Mania/Hypomania (TIMan), or a Mixed Episode (TIMix)
Hide Description The time from randomization to intervention for depression (TIDep), mania/hypomania (TIMan), or a mixed episode (TIMix) was analyzed. TIDep, TIMan, and TIMix were calculated using the log rank test with stratification for index mood state (depression, mania/hypomania, mixed mood).
Time Frame From randomization until intervention administered for depression, mania/hypomania or a mixed episode (up to Week 36)
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Hide Analysis Population Description
Randomized ITT Population
Arm/Group Title Placebo Lamotrigine
Hide Arm/Group Description:
Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Overall Number of Participants Analyzed 86 87
Mean (Standard Error)
Unit of Measure: Days
TIDep: Depression, n=22, 21 61  (1.5) 46  (1.5)
TIDep: Mania/Hypomania, n=36, 37 NA [1]   (NA) NA [1]   (NA)
TIDep: Mixed Mood, n=28, 29 59  (2.6) 159 [2]   (NA)
TIMan: Depression, n=22, 21 74  (3.9) 182 [2]   (NA)
TIMan: Mania/Hypomania, n=36, 37 139  (11.5) 61  (2.1)
TIMan: Mixed Mood, n=28, 29 105  (7.3) 148  (8.5)
TIMix: Depression, n=22, 21 37  (1.3) 158 [2]   (NA)
TIMix: Mania/Hypomania, n=36, 37 135  (6.3) 194  (7.5)
TIMix: Mixed Mood, n=28, 29 160  (10.7) 57  (2.5)
[1]
There were zero events for this endpoint in this stratum, therefore, the mean and the standard error could not be estimated.
[2]
There were 0-1 events for this endpoint in this stratum, therefore, the standard error could not be estimated.
5.Secondary Outcome
Title Number of Participants Experiencing a Relapse/Recurrence to Depression, Mania/Hypomania, or Mixed Mood State
Hide Description The number of participants requiring intervention to treat either the emergence of or a change in bipolar symptoms that is, experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state were analyzed.
Time Frame From randomization until a relapse/recurrence to depression, mania/hypomania, or mixed mood state (up to Week 36)
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized ITT Population. Only those participants requiring intervention to treat either the emergence of, or a change, in bipolar symptoms were analyzed.
Arm/Group Title Placebo Lamotrigine
Hide Arm/Group Description:
Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Overall Number of Participants Analyzed 31 18
Measure Type: Number
Unit of Measure: Participants
Depression 5 3
Mania/hypomania 16 6
Mixed episode state 10 9
6.Secondary Outcome
Title Number of Participants Experiencing a Relapse/Recurrence Within the First 30, 90, and 180 Days in the Randomized Phase
Hide Description The proportion of participants (par.) requiring intervention to treat either the emergence of or a change in bipolar symptoms, that is, experiencing a relapse/recurrence to depression, mania/hypomania, or mixed mood state at any time within the first 30, 90, and 180 days in the Randomized Phase were analyzed.
Time Frame From randomization up to Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized ITT Population. Only those participants requiring intervention to treat either the emergence of, or a change, in bipolar symptoms were analyzed.
Arm/Group Title Placebo Lamotrigine
Hide Arm/Group Description:
Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Overall Number of Participants Analyzed 31 18
Measure Type: Number
Unit of Measure: Participants
Mania/hypomania, 30 days, n=16, 6 9 2
Mania/hypomania, 90 days, n=16, 6 12 4
Mania/hypomania, 180 days, n=16, 6 16 5
Depression, 30 days, n=5, 3 1 1
Depression, 90 days, n=5, 3 5 2
Depression, 180 days, n=5, 3 5 3
Mixed mood state, 30 days, n= 10, 9 3 2
Mixed mood state, 90 days, n= 10, 9 7 6
Mixed mood state, 180 days, n= 10, 9 10 8
7.Secondary Outcome
Title Change From Baseline in the Quick Inventory of Depressive Symptomatology – Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Open-Label Phase
Hide Description The QIDS-A17-C is a 17-item scale used to assess depression severity in adolescents according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). Analysis was performed using mixed model repeated measures.
Time Frame Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18
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Hide Analysis Population Description
Open-Label ITT population: all participants who entered the Open-Label Phase and received at least one dose of LTG.
Arm/Group Title LTG: Open-Label Phase
Hide Arm/Group Description:
Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of : 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
Overall Number of Participants Analyzed 298
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a Scale
Week 1 -2.1  (0.22)
Week 2 -2.9  (0.28)
Week 3 -3.7  (0.28)
Week 4 -3.8  (0.30)
Week 5 -4.3  (0.30)
Week 6 -4.7  (0.30)
Week 7 -5.1  (0.30)
Week 8 -4.9  (0.31)
Week 9 -5.6  (0.30)
Week 10 -6.1  (0.29)
Week 11 -6.4  (0.30)
Week 12 -6.6  (0.32)
Week 13 -6.7  (0.32)
Week 14 -6.8  (0.34)
Week 15 -6.8  (0.40)
Week 16 -6.8  (0.41)
Week 17 -6.5  (0.53)
Week 18 -6.5  (0.70)
8.Secondary Outcome
Title Change From Randomization in the Quick Inventory of Depressive Symptomatology – Clinician Interview, Semi-structured, Adolescent Version (QIDS- A17-C) at Each Visit in the Randomized Phase
Hide Description The QIDS-A17-C is a 17-item scale used to assess depression severity in adolescents according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). Analysis was performed using mixed model repeated measures.
Time Frame Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36
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Hide Analysis Population Description
Randomized ITT Population
Arm/Group Title Placebo Lamotrigine
Hide Arm/Group Description:
Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Overall Number of Participants Analyzed 86 87
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 1 0.8  (0.30) 0.5  (0.31)
Week 2 1.5  (0.37) 1.1  (0.37)
Week 3 1.3  (0.36) 0.6  (0.36)
Week 4 1.2  (0.39) 1.0  (0.39)
Week 6 1.9  (0.49) 1.5  (0.47)
Week 8 1.9  (0.47) 1.7  (0.45)
Week 10 1.4  (0.44) 1.5  (0.41)
Week 12 1.4  (0.40) 1.2  (0.39)
Week 16 2.2  (0.48) 1.8  (0.47)
Week 20 1.5  (0.50) 2.5  (0.46)
Week 24 1.7  (0.53) 1.8  (0.51)
Week 28 1.6  (0.61) 2.3  (0.57)
Week 32 1.0  (0.72) 1.9  (0.72)
Week 36 2.3  (0.63) 1.9  (0.63)
9.Secondary Outcome
Title Change From Baseline in the Quick Inventory of Depressive Symptomatology – Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Open-Label Phase
Hide Description The QIDS-A17-SR is a 17-item scale used to assess depression severity in adolescents according to the DSM-IV-TR diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). The scale is completed by the participant. Analysis was performed using mixed model repeated measures.
Time Frame Baseline and Weeks 4, 8, 12, 16, and 18
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Hide Analysis Population Description
Open-Label ITT Population
Arm/Group Title LTG: Open-Label Phase
Hide Arm/Group Description:
Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
Overall Number of Participants Analyzed 298
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 4 -2.7  (0.25)
Week 8 -3.3  (0.27)
Week 12 -4.3  (0.28)
Week 16 -4.5  (0.33)
Week 18 -5.0  (0.52)
10.Secondary Outcome
Title Change From Randomization in the Quick Inventory of Depressive Symptomatology – Self-report Adolescent Version (QIDS-A17-SR) at Each Visit in the Randomized Phase
Hide Description The QIDS-A17-SR is a 17-item scale used to assess depression severity in adolescents according to the DSM-IV-TR diagnostic criteria for a major depressive episode; it is a modified version of the Quick Inventory of Depressive Symptomatology (QIDS) used for adults. Each item is scored on a 0-3 scale, yielding 9 domain scores. The range of scores is 0 (best possible outcome) to 27 (worst possible outcome). The scale is completed by the participant. Analysis was performed using mixed model repeated measures.
Time Frame Randomization and Weeks 8, 16, 24, 32, and 36
Hide Outcome Measure Data
Hide Analysis Population Description
Randomized ITT Population
Arm/Group Title Placebo Lamotrigine
Hide Arm/Group Description:
Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Overall Number of Participants Analyzed 86 87
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 8 1.6  (0.47) 1.2  (0.48)
Week 16 1.6  (0.60) 1.4  (0.58)
Week 24 1.0  (0.60) 1.5  (0.56)
Week 32 0.6  (0.66) 0.2  (0.63)
Week 36 0.9  (0.66) 0.8  (0.68)
11.Secondary Outcome
Title Change From Baseline in the Clinical Global Impressions – Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Open-Label Phase
Hide Description Severity of the bipolar illness was based on the CGI-BP(S) score which had a range from 1 (normal, not ill) to 7 (very severely ill). Analysis was performed using mixed model repeated measures.
Time Frame Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18
Hide Outcome Measure Data
Hide Analysis Population Description
Open-Label ITT Population
Arm/Group Title LTG: Open-Label Phase
Hide Arm/Group Description:
Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
Overall Number of Participants Analyzed 298
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 1 -0.4  (0.05)
Week 2 -0.6  (0.05)
Week 3 -0.9  (0.06)
Week 4 -1.0  (0.06)
Week 5 -1.2  (0.06)
Week 6 -1.3  (0.06)
Week 7 -1.4  (0.07)
Week 8 -1.5  (0.07)
Week 9 -1.6  (0.07)
Week 10 -1.8  (0.07)
Week 11 -1.9  (0.07)
Week 12 -2.1  (0.07)
Week 13 -2.1  (0.07)
Week 14 -2.1  (0.07)
Week 15 -2.1  (0.08)
Week 16 -2.1  (0.10)
Week 17 -2.0  (0.12)
Week 18 -2.1  (0.15)
12.Secondary Outcome
Title Change From Randomization in the Clinical Global Impressions – Bipolar, Severity of Illness (CGI-BP[S]) at Each Visit in the Randomized Phase
Hide Description Severity of the bipolar illness was based on the CGI-BP(S) score which had a range from 1 (normal, not ill) to 7 (very severely ill). Analysis was performed using mixed model repeated measures.
Time Frame Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36
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Hide Analysis Population Description
Randomized ITT Population
Arm/Group Title Placebo Lamotrigine
Hide Arm/Group Description:
Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Overall Number of Participants Analyzed 86 87
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 1 0.2  (0.09) 0.0  (0.09)
Week 2 0.4  (0.12) 0.2  (0.12)
Week 3 0.4  (0.12) 0.2  (0.12)
Week 4 0.6  (0.13) 0.3  (0.13)
Week 6 0.8  (0.15) 0.4  (0.15)
Week 8 0.7  (0.15) 0.4  (0.14)
Week 10 0.4  (0.13) 0.6  (0.13)
Week 12 0.5  (0.14) 0.4  (0.14)
Week 16 0.6  (0.17) 0.6  (0.15)
Week 20 0.5  (0.17) 0.8  (0.16)
Week 24 0.4  (0.17) 0.6  (0.16)
Week 28 0.3  (0.17) 0.5  (0.16)
Week 32 0.2  (0.19) 0.5  (0.20)
Week 36 0.4  (0.19) 0.3  (0.21)
13.Secondary Outcome
Title Summary of Clinical Global Impressions – Bipolar – Improvement of Illness (CGI-BP [I]) Scores During Open-label Phase
Hide Description Improvement of bipolar illness was based on the CGI-BP (I) score which ranged from 1 (very much improved) to 7 (very much worse). Analysis was performed using mixed model repeated measures.
Time Frame Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18
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Hide Analysis Population Description
Open-Label ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Open-Label Population.
Arm/Group Title LTG: Open-Label Phase
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Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
Overall Number of Participants Analyzed 298
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 1, n=290 3.6  (0.80)
Week 2, n=278 3.3  (0.90)
Week 3, n=270 3.1  (0.96)
Week 4, n=265 3.0  (1.03)
Week 5, n=258 2.8  (1.01)
Week 6, n=243 2.7  (1.05)
Week 7, n=246 2.5  (1.07)
Week 8, n=236 2.5  (1.09)
Week 9, n=227 2.3  (1.05)
Week 10, n=205 2.2  (1.09)
Week 11, n=181 2.2  (0.92)
Week 12, n=168 2.0  (0.87)
Week 13, n=141 1.9  (0.85)
Week 14, n=118 1.9  (0.69)
Week 15, n=93 1.8  (0.71)
Week 16, n=72 2.0  (0.89)
Week 17, n=42 2.0  (0.70)
Week 18, n=28 2.0  (0.88)
14.Secondary Outcome
Title Summary of Clinical Global Impressions – Bipolar – Improvement of Illness (CGI-BP [I]) Scores During Randomized Phase
Hide Description Improvement of bipolar illness was based on the CGI-BP(I) score which ranged from 1 (very much improved) to 7 (very much worse). Analysis was performed using mixed model repeated measures.
Time Frame Randomization weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32 and 36
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Randomized ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Randomized ITT Population.
Arm/Group Title Placebo Lamotrigine
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Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Overall Number of Participants Analyzed 86 87
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 1, n=84, 85 3.3  (1.40) 3.3  (1.37)
Week 2, n=82, 81 3.7  (1.48) 3.6  (1.38)
Week 3, n=74, 75 3.6  (1.39) 3.6  (1.34)
Week 4, n=65, 70 3.6  (1.51) 3.6  (1.35)
Week 6, n=58, 64 3.8  (1.64) 3.4  (1.49)
Week 8, n=51, 60 3.5  (1.72) 3.6  (1.47)
Week 10, n=45, 55 3.3  (1.64) 3.8  (1.19)
Week 12, n=45, 49 3.3  (1.52) 3.4  (1.29)
Week 16, n=43, 50 3.4  (1.73) 3.5  (1.37)
Week 20, n=37, 43 3.0  (1.48) 3.8  (1.36)
Week 24, n=34, 36 3.0  (1.59) 3.4  (1.44)
Week 28, n=29, 32 2.7  (1.56) 3.5  (1.44)
Week 32, n=28, 27 3.0  (1.63) 3.5  (1.28)
Week 36, n=27, 24 3.0  (1.68) 3.6  (1.10)
15.Secondary Outcome
Title Number of Participants Considered Much Improved or Very Much Improved [Defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), Score of 1 or 2] at Each Visit Compared to Baseline in the Open-Label Phase
Hide Description The CGI-BP(I) asks the following question: “Compared to the Baseline assessment in this trial, how much has the participant changed?”. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). The investigator or their designee rated improvement regardless of whether the improvement to be due to drug treatment. Improvement defined as CGI-BP(I)=1 (improved) or 2 (very much improved). Missing data imputed using last-observation carried forward (LOCF).
Time Frame Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18
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Open-Label ITT Population. Only those par. available at the specified time points were analyzed (represented by n=X). Different par. may have been analyzed at different time points, so the overall number of par. analyzed reflects everyone in the Open-Label Population.
Arm/Group Title LTG: Open-Label Phase
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Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
Overall Number of Participants Analyzed 298
Measure Type: Number
Unit of Measure: Participants
Week 1, n=297 27
Week 2, n=297 46
Week 3, n=297 72
Week 4, n=297 86
Week 5, n=297 113
Week 6, n=297 124
Week 7, n=297 138
Week 8, n=297 140
Week 9, n=297 159
Week 10, n=297 176
Week 11, n=297 182
Week 12, n=297 195
Week 13, n=297 205
Week 14, n=297 211
Week 15, n=297 210
Week 16, n=297 209
Week 17, n=297 208
Week 18, n=297 206
16.Secondary Outcome
Title Number of Participants Considered Much Improved or Very Much Improved [Defined as a Clinical Global Impression-Bipolar Version, Improvement of Illness (CGI-BP[I]), Score of 1 or 2] at Each Visit Compared to Randomization in the Randomized Phase
Hide Description The CGI-BP(I) asks the following question: “Compared to the Randomization assessment in this trial, how much has the participant changed?”. Scores on the CGI-I range from 1 (very much improved) to 7 (very much worse). The investigator or their designee rated improvement regardless of whether the improvement to be due to drug treatment. Improvement defined as CGI-BP(I)=1 (improved) or 2 (very much improved). Missing data imputed using last-observation carried forward (LOCF).
Time Frame Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36
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Randomized ITT Population
Arm/Group Title Placebo Lamotrigine
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Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Overall Number of Participants Analyzed 86 87
Measure Type: Number
Unit of Measure: Participants
Week 1 31 31
Week 2 25 22
Week 3 24 21
Week 4 22 19
Week 6 20 23
Week 8 22 19
Week 10 22 12
Week 12 21 17
Week 16 21 16
Week 20 21 14
Week 24 21 15
Week 28 22 15
Week 32 19 15
Week 36 20 13
17.Secondary Outcome
Title Change From Baseline in the Young Mania Rating Scale (YMRS) at Each Visit in the Open-Label Phase
Hide Description The YMRS consists of 11 items and is based on the participant's report of their mania symptoms. It is clinician rated. Four items (irritability, speech, thought content, and disruptive/aggressive behavior) are rated on a scale of 0 to 8, while the other seven items (elevated mood, increased motor activity-energy, sexual interest, sleep, language, appearance, and insight) are rated on a scale of 0 to 4. The range of scores for the YMRS is 0 (best possible outcome) to 60 (worst possible outcome). The YMRS was completed by the investigator or their qualified designee. Analysis was performed using mixed model repeated measures.
Time Frame Baseline and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18
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Open-Label ITT Population
Arm/Group Title LTG: Open-Label Phase
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Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
Overall Number of Participants Analyzed 298
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 1 -3.2  (0.39)
Week 2 -4.8  (0.42)
Week 3 -6.4  (0.45)
Week 4 -6.5  (0.46)
Week 5 -7.5  (0.50)
Week 6 -8.4  (0.50)
Week 7 -9.1  (0.51)
Week 8 -8.8  (0.48)
Week 9 -9.6  (0.48)
Week 10 -10.3  (0.49)
Week 11 -11.1  (0.48)
Week 12 -11.6  (0.53)
Week 13 -12.0  (0.58)
Week 14 -12.0  (0.59)
Week 15 -12.4  (0.63)
Week 16 -12.3  (0.78)
Week 17 -12.2  (0.88)
Week 18 -12.1  (1.43)
18.Secondary Outcome
Title Change From Randomization in the Young Mania Rating Scale (YMRS) at Each Visit in the Randomized Phase
Hide Description The YMRS consists of 11 items and is based on the participant's report of their mania symptoms. It is clinician rated. Four items (irritability, speech, thought content, and disruptive/aggressive behavior) are rated on a scale of 0 to 8, while the other seven items (elevated mood, increased motor activity-energy, sexual interest, sleep, language, appearance, and insight) are rated on a scale of 0 to 4. The range of scores for the YMRS is 0 (best possible outcome) to 60 (worst possible outcome). The YMRS was completed by the investigator or their qualified designee. Analysis was performed using mixed model repeated measures.
Time Frame Randomization and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 32, and 36
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Randomized ITT Population
Arm/Group Title Placebo Lamotrigine
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Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Overall Number of Participants Analyzed 86 87
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 1 1.3  (0.57) 0.4  (0.59)
Week 2 2.6  (0.72) 2.1  (0.72)
Week 3 2.6  (0.69) 1.3  (0.71)
Week 4 3.7  (0.85) 2.0  (0.84)
Week 6 4.9  (0.96) 2.3  (0.93)
Week 8 4.3  (0.98) 3.5  (0.93)
Week 10 3.5  (0.87) 2.9  (0.82)
Week 12 3.2  (0.84) 1.6  (0.81)
Week 16 4.7  (0.93) 3.0  (0.89)
Week 20 4.8  (0.99) 4.5  (0.92)
Week 24 4.2  (1.06) 2.9  (1.02)
Week 28 4.4  (1.04) 3.7  (1.01)
Week 32 4.5  (1.10) 2.6  (1.14)
Week 36 3.5  (0.92) 1.2  (0.95)
19.Secondary Outcome
Title Change From Baseline in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Open-Label Phase
Hide Description The P-YMRS was adapted from the YMRS for completion by parents of the pediatric participants with bipolar disorder in order to assess the severity of the manic symptoms. The P-YMRS consisted of 11 items and had a total score range of 0 (best possible outcome) to 60 (worst possible outcome). The P-YMRS was completed by the participant's custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.
Time Frame Baseline and Weeks 4, 8, 12, 16, and 18
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Open-Label ITT Population
Arm/Group Title LTG: Open-Label Phase
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Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
Overall Number of Participants Analyzed 298
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 4 -4.7  (0.57)
Week 8 -6.0  (0.62)
Week 12 -7.4  (0.62)
Week 16 -8.2  (0.72)
Week 18 -9.3  (1.29)
20.Secondary Outcome
Title Change From Randomization in the Parent Version of the Young Mania Rating Scale (P-YMRS) at Each Visit in the Randomized Phase
Hide Description The P-YMRS was adapted from the YMRS for completion by parents of the pediatric participants with bipolar disorder in order to assess the severity of the manic symptoms. The P-YMRS consisted of 11 items and had a total score range of 0 (best possible outcome) to 60 (worst possible outcome). The P-YMRS was completed by the participant's custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.
Time Frame Randomization and Weeks 8, 16, 24, 32, and 36
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Randomized ITT Population
Arm/Group Title Placebo Lamotrigine
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Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Overall Number of Participants Analyzed 86 87
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 8 4.9  (0.93) 4.3  (0.95)
Week 16 2.7  (1.13) 2.6  (1.09)
Week 24 5.3  (1.35) 5.7  (1.29)
Week 32 5.1  (1.33) 6.0  (1.32)
Week 36 5.3  (1.33) 4.5  (1.36)
21.Secondary Outcome
Title Change From Baseline in the Conners’ Global Index – Parent Version (CGI-P) at Each Visit in the Open-Label Phase
Hide Description The CGI-P is a 10-item scale used to assess attention deficit hyperactivity disorder (ADHD) symptoms in children and adolescents aged 3-17 years of age. The scale is composed of two factors: restless-impulsive behavior and emotional lability. Each item was scored on a 0-3 scale. The range of scores for the CGI-P is 0 (best possible outcome) to 30 (worst possible outcome). The CGI-P was completed by the participant’s custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.
Time Frame Baseline and Weeks 4, 8, 12, 16, and 18
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Open-Label ITT Population
Arm/Group Title LTG: Open-Label Phase
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Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of: 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks.
Overall Number of Participants Analyzed 298
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 4 -4.0  (0.36)
Week 8 -5.7  (0.43)
Week 12 -6.7  (0.47)
Week 16 -7.1  (0.56)
Week 18 -8.2  (1.07)
22.Secondary Outcome
Title Change From Randomization in the Conners’ Global Index – Parent Version (CGI-P) at Each Visit in the Randomized Phase.
Hide Description The CGI-P is a 10-item scale used to assess attention deficit hyperactivity disorder (ADHD) symptoms in children and adolescents aged 3-17 years of age. The scale is composed of two factors: restless-impulsive behavior and emotional lability. Each item was scored on a 0-3 scale. The range of scores for the CGI-P is 0 (best possible outcome) to 30 (worst possible outcome). The CGI-P was completed by the participant’s custodial parent or legal guardian. Analysis was performed using mixed model repeated measures.
Time Frame Randomization and Weeks 8, 16, 24, 32, and 36
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Randomized ITT Population
Arm/Group Title Placebo Lamotrigine
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Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks.
Overall Number of Participants Analyzed 86 87
Least Squares Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 8 3.1  (0.75) 2.1  (0.77)
Week 16 3.4  (0.92) 1.2  (0.90)
Week 24 2.4  (1.12) 3.1  (1.05)
Week 32 2.7  (1.10) 2.6  (1.08)
Week 36 1.5  (1.00) 0.5  (1.03)
Time Frame On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the first dose of investigational product until the last visit of the Open-Label or Double-Blind Taper and Follow-up Phase (up to Taper Week 4).
Adverse Event Reporting Description On-treatment SAEs and non-serious AEs, were reported for ITT population (Open-Label and Randomized Phase), comprised of all participants who were randomized to LTG or placebo (only for Randomized Phase) and received at least one dose of the investigational product.
 
Arm/Group Title Open-Label and Open-Label Taper Phases: LTG Randomized and Double-blind Taper Phases: Placebo Randomized and Double-blind Taper Phases: LTG
Hide Arm/Group Description Participants (par.) received lamotrigine (LTG) up to a maximum dose depending on their age and concomitant bipolar medication group. Participants 10 -12 years of age received LTG up to a maximum dose of : 3 milligrams/kilograms (mg/kg)/day or 100 mg/day, whichever was less; or 6 mg/kg/day or 200 mg/day whichever was less; or 12 mg/kg/day or 300 mg/day whichever was less, depending on their bipolar medication group. Participants 13-17 years of age received LTG up to a maximum dose of 150 mg/day, 300 mg/day, or 400 mg/day depending on their bipolar medication group. Participants took LTG for a duration of up to 18 weeks. Participants discontinuing from the study during the Open-Label Phase entered an open Taper and Follow-up Phase.The Taper and Follow-up Phase may last up to 4 weeks, dependent on the dose of LTG the participant received during the Open-Label Phase. Participants received matching placebo in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks. Participants completing the Randomized Phase entered Double-Blind Taper and Follow-up Phase. The Taper and Follow-up Phase may last up to 4 weeks. The participant received Placebo during this Phase. Participants received LTG equivalent to the dose established in the Open-Label Phase. Participants received LTG tablets in the evening for participants taking one dose and for participants taking two divided doses, one dose in the morning and one dose in the evening, for a duration of up to 36 weeks. Participants completing the Randomized Phase entered Double-Blind Taper and Follow-up Phase. The Taper and Follow-up Phase may last up to 4 weeks, dependent on the dose of LTG the participant received during the Randomized Phase.
All-Cause Mortality
Open-Label and Open-Label Taper Phases: LTG Randomized and Double-blind Taper Phases: Placebo Randomized and Double-blind Taper Phases: LTG
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Open-Label and Open-Label Taper Phases: LTG Randomized and Double-blind Taper Phases: Placebo Randomized and Double-blind Taper Phases: LTG
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   19/298 (6.38%)   5/86 (5.81%)   1/87 (1.15%) 
General disorders       
Irritability  1  2/298 (0.67%)  0/86 (0.00%)  0/87 (0.00%) 
Infections and infestations       
Infectious mononucleosis  1  0/298 (0.00%)  1/86 (1.16%)  0/87 (0.00%) 
Urinary tract infection  1  0/298 (0.00%)  1/86 (1.16%)  0/87 (0.00%) 
Injury, poisoning and procedural complications       
Intentional overdose  1  0/298 (0.00%)  1/86 (1.16%)  0/87 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasm  1  1/298 (0.34%)  0/86 (0.00%)  0/87 (0.00%) 
Psychiatric disorders       
Suicidal ideation  1  5/298 (1.68%)  1/86 (1.16%)  0/87 (0.00%) 
Agitation  1  3/298 (1.01%)  0/86 (0.00%)  0/87 (0.00%) 
Mania  1  3/298 (1.01%)  1/86 (1.16%)  0/87 (0.00%) 
Aggression  1  1/298 (0.34%)  0/86 (0.00%)  0/87 (0.00%) 
Anxiety  1  1/298 (0.34%)  0/86 (0.00%)  0/87 (0.00%) 
Bipolar I disorder  1  1/298 (0.34%)  1/86 (1.16%)  0/87 (0.00%) 
Bipolar disorder  1  1/298 (0.34%)  0/86 (0.00%)  0/87 (0.00%) 
Impulsive behaviour  1  1/298 (0.34%)  0/86 (0.00%)  0/87 (0.00%) 
Intentional self-injury  1  1/298 (0.34%)  0/86 (0.00%)  0/87 (0.00%) 
Pressure of speech  1  1/298 (0.34%)  0/86 (0.00%)  0/87 (0.00%) 
Emotional disorder  1  0/298 (0.00%)  0/86 (0.00%)  1/87 (1.15%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/298 (0.34%)  0/86 (0.00%)  0/87 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash  1  1/298 (0.34%)  0/86 (0.00%)  0/87 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Open-Label and Open-Label Taper Phases: LTG Randomized and Double-blind Taper Phases: Placebo Randomized and Double-blind Taper Phases: LTG
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   177/298 (59.40%)   41/86 (47.67%)   45/87 (51.72%) 
Gastrointestinal disorders       
Abdominal pain upper  1  47/298 (15.77%)  3/86 (3.49%)  5/87 (5.75%) 
Nausea  1  39/298 (13.09%)  0/86 (0.00%)  0/87 (0.00%) 
Diarrhoea  1  23/298 (7.72%)  0/86 (0.00%)  0/87 (0.00%) 
Vomiting  1  25/298 (8.39%)  3/86 (3.49%)  5/87 (5.75%) 
General disorders       
Irritability  1  16/298 (5.37%)  14/86 (16.28%)  7/87 (8.05%) 
Fatigue  1  17/298 (5.70%)  0/86 (0.00%)  0/87 (0.00%) 
Pyrexia  1  0/298 (0.00%)  5/86 (5.81%)  2/87 (2.30%) 
Infections and infestations       
Nasopharyngitis  1  25/298 (8.39%)  5/86 (5.81%)  7/87 (8.05%) 
Influenza  1  0/298 (0.00%)  2/86 (2.33%)  7/87 (8.05%) 
Nervous system disorders       
Headache  1  106/298 (35.57%)  18/86 (20.93%)  18/87 (20.69%) 
Dizziness  1  24/298 (8.05%)  0/86 (0.00%)  0/87 (0.00%) 
Psychiatric disorders       
Insomnia  1  23/298 (7.72%)  5/86 (5.81%)  6/87 (6.90%) 
Suicidal ideation  1  16/298 (5.37%)  0/86 (0.00%)  0/87 (0.00%) 
Agitation  1  0/298 (0.00%)  1/86 (1.16%)  5/87 (5.75%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  21/298 (7.05%)  4/86 (4.65%)  7/87 (8.05%) 
Oropharyngeal pain  1  30/298 (10.07%)  2/86 (2.33%)  7/87 (8.05%) 
Nasal congestion  1  0/298 (0.00%)  6/86 (6.98%)  6/87 (6.90%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00723450     History of Changes
Other Study ID Numbers: SCA102833
First Submitted: July 24, 2008
First Posted: July 28, 2008
Results First Submitted: March 27, 2014
Results First Posted: June 4, 2014
Last Update Posted: January 9, 2017