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An Open-Label Trial Measuring Satisfaction And Convenience Of Two Formulations Of Lamotrigine In Subjects With A Mood Disorder

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ClinicalTrials.gov Identifier: NCT00579982
Recruitment Status : Completed
First Posted : December 24, 2007
Results First Posted : August 3, 2009
Last Update Posted : December 16, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mood Disorders
Intervention Drug: Lamotrigine
Enrollment 97
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lamotrigine
Hide Arm/Group Description Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Period Title: Overall Study
Started 97
Completed 89
Not Completed 8
Reason Not Completed
Adverse Event             4
Protocol Violation             4
Arm/Group Title Lamotrigine
Hide Arm/Group Description Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Baseline Participants 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants
41.0  (12.07)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants
Female
83
  85.6%
Male
14
  14.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 97 participants
White 94
Black 2
Mixed race 1
1.Primary Outcome
Title Mean Change From Baseline in the Convenience Subscale Score (CSS) Derived From the Treatment Satisfaction Questionnaire for Medication (TSQM v 1.4) Using Items 9 (Ease of Use), 10 (Ease of Planning to Use), and 11 (Convenience) at Week 3.
Hide Description The CSS is the sum of items 9 (values: 1=Extremely difficult - 7=Extremely easy), 10 (same set of values as for 9), and 11 (1=Extremely inconvenient - 7=Extremely convenient). The sum has 3 subtracted from it, is divided by 18, and then multiplied by 100; the range is 0-100. Change from baseline=end of study CSS minus baseline score.
Time Frame Baseline, End of Study (Week 3) or Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT). Ninety-eight participants were enrolled in the study, but one withdrew prior to receiving lamotrigine ODT treatment. All efficacy and safety analyses are based on the Intent to Treat population, which includes the 97 patients who received at least one dose of ODT treatment.
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 97
Mean (Standard Deviation)
Unit of Measure: Points on a subscale
23.3  (22.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lamotrigine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Paired t-test
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline in the Global Satisfaction Subscale Score, From the TSQM Using Items 12 (Confidence in Medicine), 13 (Certainty That Good Things About Medication Outweigh Bad Things), and 14 (Satisfaction With Medication) at Week 3
Hide Description The Global Satisfaction Subscale Score is the sum of item 12 (values: 1=Not at all confident - 5=Extremely confident), item 13 (values: 1=Not at all certain - 5=Extremely certain), and item 14 (Extremely dissatisfied - 7=Extremely satisfied). The sum has 3 subtracted from it, is divided by 14, and then multiplied by 100; thus, the range is 0-100.
Time Frame Baseline, End of Study (Week 3) or Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 97
Mean (Standard Deviation)
Unit of Measure: Points on a subscale
-0.3  (29.34)
3.Secondary Outcome
Title Mean Change From Baseline in Clinical Global Impression of Illness-Severity at Week 3
Hide Description Clinician assessment evaluating how mentally ill the patient is at time of evaluation. The questionnaire is based on a 7-point scale (from1 = Normal to 7 = Among the most extremely ill patients).
Time Frame Baseline, End of Study (Week 3) or at Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 96
Mean (Standard Deviation)
Unit of Measure: Points on a scale
0.0  (0.81)
4.Secondary Outcome
Title Mean Change From Baseline in the Beck Depression Inventory (BDI-II) Score at Week 3
Hide Description Participant-reported questionnaire consisting of 21 items on a 4 point scale (0 to 3, with 3 indicating most severely ill), with the score being the sum of the items. The change from baseline is the end of study score minus the baseline score; larger values indicate more depression with the ODT formulation relative to the IR formulation.
Time Frame Baseline, End of Study (Week 3 weeks) or at Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 97
Mean (Standard Deviation)
Unit of Measure: Points on a scale
-1.7  (9.52)
5.Secondary Outcome
Title Number of Participants Answering the Question "Did the Tablets Dissolve Instantly (Yes or no)?" at Week 3
Hide Description The Organoleptic Questionnaire (9 items) was used to assess the participants' satisfaction with the physical characteristics of the ODT formulation e.g. rate of dissolution, flavor. Question number 1 on organoleptic questionnaire: Did the tablets dissolve instantly (yes or no)?
Time Frame End of Study (Week 3) or Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: Number of participants
Yes 60
No 37
6.Secondary Outcome
Title Number of Participants Answering the Question "How Satisfied or Dissatisfied Were You With the Time it Took the Tablet to Dissolve" at Week 3
Hide Description Question number 2 on organoleptic questionnaire: How satisfied or dissatisfied were you with the time it took the tablet to dissolve? [from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)]
Time Frame Baseline, End of Study (Week 3) or Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: Number of participants
Extremely dissatisfied 3
Very dissatisfied 10
Satisfied 37
Very satisfied 18
Extremely satisfied 29
7.Secondary Outcome
Title Number of Participants Answering the Question “How Did the Dissolved Tablet Feel in Your Mouth?” at Week 3
Hide Description Question number 3 on organoleptic questionnaire: How did the dissolved tablet feel in your mouth? [from a rating of 1 (Extremely gritty) to 5 (Extremely smooth)]
Time Frame End of Study (Week 3) or Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: Number of participants
Extremely gritty 0
Very gritty 19
Smooth 45
Very smooth 19
Extremely smooth 14
8.Secondary Outcome
Title Number of Participants Answering the Question "How Satisfied Were You With the Flavor of the Tablet?" at Week 3
Hide Description Question number 4 on organoleptic questionnaire: How satisfied were you with the flavor of the tablet? [from a rating of 1 (Extremely dissatisfied) to 5 (Extremely satisfied)]
Time Frame End of Study (Week 3) or Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: Number of participants
Extremely dissatisfied 5
Very dissatisfied 10
Satisfied 26
Very satisfied 23
Extremely satisfied 33
9.Secondary Outcome
Title Number of Participants Answering the Question "How Would You Rate the Strength of the Flavor of the Tablet"? at Week 3
Hide Description Organoleptic Questionnaire, question 5: How would you rate the strength of the flavor of the tablet? [from 1 a rating of (Extremely bothersome) to 5 (Extremely pleasant)]
Time Frame End of Study (Week 3) or Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: Number of participants
Extremely bothersome 2
Very bothersome 14
Pleasant 36
Very pleasant 22
Extremely pleasant 23
10.Secondary Outcome
Title Number of Participants Answering the Question "How Would You Rate the Aftertaste of the Tablet"? at Week 3.
Hide Description Organoleptic Questionnaire, question 6: How would you rate the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? [from a rating of 1 (Extremely bothersome) to 6 (Did NOT experience an aftertaste)]
Time Frame End of Study (Week 3) or Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: Number of participants
Extremely bothersome 4
Very bothersome 20
Pleasant 25
Very pleasant 7
Extremely pleasant 12
I did NOT experience an aftertaste 29
11.Secondary Outcome
Title Number of Participants Answering the Question "How Satisfied Were You With the Aftertaste of the Tablet"? at Week 3
Hide Description Organoleptic Questionnaire, question 7: How satisfied were you with the aftertaste of the tablet (the taste remaining in your mouth after swallowing the tablet)? [from a rating of 1 (Extremely dissatisfied) to 6 (I did NOT experience an aftertaste)]
Time Frame Baseline, End of Study (Week 3) or Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: Number of participants
Extremely dissatisfied 3
Very dissatisfied 16
Satisfied 28
Very satisfied 11
Extremely satisfied 11
I did NOT experience an aftertaste 28
12.Secondary Outcome
Title Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Convenient or Inconvenient Did You Find This Orally Disintegrating Tablet"? at Week 3
Hide Description Organoleptic Questionnaire, question 8: Compared to standard tablets that need to be swallowed with liquid, how convenient or inconvenient did you find this orally disintegrating tablet? (from a rating of 1 [Extremely inconvenient] to 5 [Extremely convenient])
Time Frame End of Study (Week 3) or at Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: Number of participants
Extremely inconvenient 8
Very inconvenient 9
Convenient 16
Very convenient 17
Extremely convenient 47
13.Secondary Outcome
Title Number of Participants Answering the Question "Compared to Standard Tablets That Need to be Swallowed With Liquid, How Easy or Difficult is it to Use This Orally Disintegrating Tablet?" at Week 3
Hide Description Organoleptic Questionnaire, question 9: Compared to standard tablets that need to be swallowed with liquid, how easy or difficult is it to use this orally disintegrating tablet? [from a rating of 1 (Extremely difficult) to 5 (Extremely easy)]
Time Frame End of Study (Week 3) or at Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: Number of participants
Extremely difficult 2
Very difficult 3
Easy 17
Very easy 20
Extremely easy 55
14.Secondary Outcome
Title Number of Participants Indicating a Preference for ODT or the Standard IR Tablet at Week 3
Hide Description Participant indicated whether preference was for ODT or the standard IR tablet
Time Frame End of Study (Week 3) or at Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: Number of participants
Prefer ODT 72
Prefer standard IR tablet 25
15.Secondary Outcome
Title Number of Companions/Caregivers Indicating Whether ODT or Standard IR Tablet is More Convenient at Week 3
Hide Description Companion/Caregiver indicates whether ODT is more convenient or standard IR tablet is more convenient
Time Frame End of Study (Week 3) or at Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: Number of participants
ODT more convenient 79
Standard IR tablet more convenient 18
16.Secondary Outcome
Title Number of Participants Indicating at Week 3 (by Answering Yes/no) That They Would be More Likely to Take the ODT Formulation
Hide Description Tablet Routine Questionnaire (Adherence): Adherence to the treatment was evaluated by asking if the participant would be more likely to take the ODT formulation (yes/no)
Time Frame End of Study (Week 3) or at Early Withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT: Only 94 of the 97 subjects in the ITT Population responded to the Tablet Routine Questionnaire.
Arm/Group Title Lamotrigine
Hide Arm/Group Description:
Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
Overall Number of Participants Analyzed 94
Measure Type: Number
Unit of Measure: Number of participants
Yes 84
No 10
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lamotrigine
Hide Arm/Group Description Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
All-Cause Mortality
Lamotrigine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lamotrigine
Affected / at Risk (%)
Total   1/97 (1.03%) 
Cardiac disorders   
Myocardial infarction  1  1/97 (1.03%) 
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 1%
Lamotrigine
Affected / at Risk (%)
Total   28/97 (28.87%) 
Eye disorders   
Vision blurred  1  1/97 (1.03%) 
Gastrointestinal disorders   
Nausea  1  2/97 (2.06%) 
Abdominal pain upper  1  1/97 (1.03%) 
Gastrooeophageal reflux disease  1  1/97 (1.03%) 
Glossodynia  1  1/97 (1.03%) 
Vomiting  1  1/97 (1.03%) 
General disorders   
Chest pain  1  1/97 (1.03%) 
Influenza-like illness  1  1/97 (1.03%) 
Irritability  1  1/97 (1.03%) 
Pain  1  1/97 (1.03%) 
Infections and infestations   
Bronchitis  1  1/97 (1.03%) 
Influenza  1  1/97 (1.03%) 
Nasopharyngitis  1  1/97 (1.03%) 
Pneumonia  1  1/97 (1.03%) 
Upper respiratory infection  1  1/97 (1.03%) 
Urinary tract infection  1  1/97 (1.03%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/97 (1.03%) 
Muscle spasms  1  1/97 (1.03%) 
Pain in extremity  1  1/97 (1.03%) 
Nervous system disorders   
Headache  1  5/97 (5.15%) 
Dizziness  1  1/97 (1.03%) 
Psychiatric disorders   
Anxiety  1  3/97 (3.09%) 
Depression  1  3/97 (3.09%) 
Hypomania  1  3/97 (3.09%) 
Depressed mood  1  1/97 (1.03%) 
Insomnia  1  1/97 (1.03%) 
Restlessness  1  1/97 (1.03%) 
Suicidal ideation  1  1/97 (1.03%) 
Respiratory, thoracic and mediastinal disorders   
Sinus congestion  1  1/97 (1.03%) 
Upper respiratory tract congestion  1  1/97 (1.03%) 
Skin and subcutaneous tissue disorders   
Rosacea  1  1/97 (1.03%) 
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
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00579982     History of Changes
Other Study ID Numbers: LBI108884
First Submitted: December 20, 2007
First Posted: December 24, 2007
Results First Submitted: June 4, 2009
Results First Posted: August 3, 2009
Last Update Posted: December 16, 2016