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Trial record 75 of 83 for:    CARBAMAZEPINE AND Cytochrome P-450 CYP3A Inducers

Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder

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ClinicalTrials.gov Identifier: NCT00266630
Recruitment Status : Completed
First Posted : December 19, 2005
Results First Posted : June 29, 2010
Last Update Posted : December 28, 2010
Sponsor:
Information provided by:
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Manic or Mixed Episode Associated With Bipolar I Disorder
Interventions Drug: olanzapine
Drug: lithium
Drug: valproate
Drug: carbamazepine
Enrollment 139
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks. Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Period Title: Overall Study
Started 100 39
Completed 58 11
Not Completed 42 28
Reason Not Completed
Adverse Event             8             6
Lack of Efficacy             1             4
Entry Criteria not met             1             0
Protocol Violation             1             3
Physician Decision             1             2
Withdrawal by Subject             10             2
Lost to Follow-up             1             0
Not Specified             19             11
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer Total
Hide Arm/Group Description Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks. Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks. Total of all reporting groups
Overall Number of Baseline Participants 100 39 139
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 39 participants 139 participants
41.8  (11.7) 43.2  (11.1) 42.2  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 39 participants 139 participants
Female
59
  59.0%
21
  53.8%
80
  57.6%
Male
41
  41.0%
18
  46.2%
59
  42.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Japanese Number Analyzed 100 participants 39 participants 139 participants
100 39 139
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 100 participants 39 participants 139 participants
100 39 139
Current Episode - Mixed or Manic   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 39 participants 139 participants
Manic 88 39 127
Mixed 12 0 12
[1]
Measure Description: Description of the bipolar episode the participant experienced when enrolling into the study.
Current Episode - Psychotic or Nonpsychotic   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 39 participants 139 participants
Psychotic 13 9 22
Nonpsychotic 87 30 117
[1]
Measure Description: Description of the bipolar episode the participant experienced when enrolling into the study.
Rapid Cyclers   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 100 participants 39 participants 139 participants
Rapid Cyclers 7 3 10
Non-Rapid Cyclers 93 36 129
[1]
Measure Description: A rapid cycler is defined as a person who experiences four or more mood swings or episodes in a twelve-month period.
Clinical Global Impressions - Bipolar Version, Severity of Illness (CGI-BP) overall   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 100 participants 39 participants 139 participants
1.9  (1.0) 4.7  (0.8) 2.7  (1.6)
[1]
Measure Description: Measures severity of the patient's overall severity of bipolar symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Hamilton Depression Scale - 17 item version (HAMD-17) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 100 participants 39 participants 139 participants
1.8  (3.1) 4.4  (3.9) 2.5  (3.5)
[1]
Measure Description: The 17-item HAMD measures depression severity. Each item was evaluated and scored using a 3-point scale (e.g. absent, mild, marked) or a 5-point scale (e.g. absent, mild, moderate, severe, very severe). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Length of Current Episode  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 100 participants 39 participants 139 participants
33.5  (23.9) 35.0  (26.7) 33.9  (24.6)
Mean Age at Onset of Illness  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 39 participants 139 participants
31.5  (11.6) 29.8  (8.4) 31.0  (10.8)
Young Mania Rating Scale (YMRS) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 100 participants 39 participants 139 participants
5.7  (6.4) 33.2  (6.6) 13.4  (13.9)
[1]
Measure Description: The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
1.Primary Outcome
Title Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Scores - Olanzapine Monotherapy Arm Only
Hide Description The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The primary objective was only interested in the effects in the olanzapine monotherapy arm, thus the results for the olanzapine + mood stabilizer arm are presented as secondary outcomes. Analyzed were all participants in the olanzapine monotherapy arm who had baseline and post-baseline measurements. Last observation carried forward.
Arm/Group Title Olanzapine Monotherapy
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.0  (5.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olanzapine Monotherapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.0
Confidence Interval (2-Sided) 95%
-4.10 to -1.90
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Participants With Response of Manic Symptoms - Olanzapine Monotherapy Arm Only
Hide Description Defined by a 50% or more reduction in YMRS total score from baseline in Study BMAC to endpoint. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed were all participants in the olanzapine monotherapy arm who had baseline and post-baseline measurements. Last observation carried forward.
Arm/Group Title Olanzapine Monotherapy
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: participants
97
3.Primary Outcome
Title Number of Participants With Remission of Mania - Olanzapine Monotherapy Arm Only
Hide Description Remission of Mania was defined as a YMRS total score of less than or equal to 12 at endpoint. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed were all participants in the olanzapine monotherapy arm who had baseline and post-baseline measurements. Last observation carried forward.
Arm/Group Title Olanzapine Monotherapy
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: participants
93
4.Primary Outcome
Title Number of Participants With Relapse of Manic Symptoms - Olanzapine Monotherapy Arm Only
Hide Description Patients achieved remission in Study BMAC (defined as YMRS total score <=12 and HAMD-17 total score <=7) and obtained YMRS total score of >=15 at any time during Study BMEX. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed were all participants in the olanzapine monotherapy group who were in remission at baseline (end of Study BMAC) with 12 points or less in YMRS total score and 7 points or less in the 17-item Hamilton Depression Rating Scale total score.
Arm/Group Title Olanzapine Monotherapy
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
Overall Number of Participants Analyzed 79
Measure Type: Number
Unit of Measure: participants
3
5.Secondary Outcome
Title Change From Baseline to Endpoint on the YMRS Total Score - Olanzapine + Mood Stabilizer Only
Hide Description The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60.
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.
Arm/Group Title Olanzapine + Mood Stabilizer
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
-19.8  (17.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olanzapine + Mood Stabilizer
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -19.8
Confidence Interval (2-Sided) 95%
-25.58 to -14.06
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Clinical Global Impressions - Bipolar Version, Severity of Illness (CGI-BP) Overall, Visit Data
Hide Description Measures severity of the patient's overall severity of bipolar symptoms (1=normal, not at all ill; 7=among the most extremely ill patients).
Time Frame baseline, Weeks 1, 2, 4, 6, 10, 14, 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Overall Number of Participants Analyzed 100 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 1.9  (1.0) 4.7  (0.8)
1 week 1.8  (1.0) 4.1  (1.2)
2 weeks 1.8  (1.0) 3.7  (1.3)
4 weeks 1.7  (1.0) 3.5  (1.6)
6 weeks 1.7  (1.1) 3.4  (1.7)
10 weeks 1.7  (1.1) 3.0  (1.8)
14 weeks 1.8  (1.2) 3.0  (1.9)
18 weeks endpoint 1.7  (1.2) 2.9  (2.0)
7.Secondary Outcome
Title Number of Participants Who Experienced Switch to Symptomatic Depression as Measured by the Hamilton Depression Scale - 17 Item Version (HAMD-17)
Hide Description Incidence of depressive symptoms was defined as a score of equal to or more than 13 points on the HAMD-17. The 17-item HAMD measures depression severity. Each item was evaluated and scored a 3-point scale (e.g. absent, mild, marked) or a 5-point scale (e.g. absent, mild, moderate, severe, very severe). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed were all participants who had equal to or less than 7 points on the HAMD-17 total score at baseline.
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Overall Number of Participants Analyzed 92 30
Measure Type: Number
Unit of Measure: participants
4 1
8.Secondary Outcome
Title Number of Participants With Relapse of Depressive Symptoms
Hide Description Assessed were participants meeting remission criteria for bipolar disorder in Study BMAC and have a HAMD-17 total score greater than or equal to 13 at any time. The 17-item HAMD measures depression severity. Each item was evaluated and scored using a 3-point scale (e.g. absent, mild, marked) or a 5-point scale (e.g. absent, mild, moderate, severe, very severe). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed were all participants in the olanzapine monotherapy group who had 12 points or less in the YMRS total score and 7 points or less in the HAMD-17 total score at baseline.
Arm/Group Title Olanzapine Monotherapy
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
Overall Number of Participants Analyzed 79
Measure Type: Number
Unit of Measure: participants
4
9.Secondary Outcome
Title Number of Participants Who Experienced Remission of Bipolar Disorder
Hide Description Participants who had equal to or less than 12 points in YMRS total score and equal to or less than 7 points in HAMD-17 total score at 18 weeks. YMRS: 11-item scale, measures the severity of manic episodes. 4 items are rated from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total: 0 to 60. The 17-item HAMD measures depression severity. Each item was evaluated and scored using a 3-point scale or a 5-point scale. HAMD-17 total score: 0 (normal) to 52 (severe).
Time Frame Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Overall Number of Participants Analyzed 100 39
Measure Type: Number
Unit of Measure: participants
54 12
10.Secondary Outcome
Title Positive and Negative Syndrome Scale Positive Scores - Visit Data
Hide Description Assesses positive symptoms associated with schizophrenia. 7 items make up the Positive scale. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total Positive Subscale scores range from 7 to 49. For the analysis, the score was converted to 0 to 6 for each item range; hence, the total score ranges from 0 to 42.
Time Frame baseline, Weeks 1, 2, 4, 6, 10, 14, 18
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Overall Number of Participants Analyzed 100 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
baseline 7.7  (1.8) 12.5  (5.7)
1 week 7.5  (1.6) 10.5  (4.1)
2 weeks 7.5  (1.4) 10.1  (3.9)
4 weeks 7.4  (1.4) 10.1  (5.4)
6 weeks 7.3  (1.2) 10.1  (5.4)
10 weeks 7.4  (1.7) 9.9  (5.4)
14 weeks 7.4  (1.7) 9.9  (5.4)
18 week endpoint 7.4  (1.7) 9.9  (5.4)
11.Secondary Outcome
Title Number of Participants Who Switched to Syndromic Depression
Hide Description As defined as a shift from a Manic Episode at baseline to a Major Depressive Episode, at any post baseline visit, based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision.
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed were all participants who had a manic episode at baseline.
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Overall Number of Participants Analyzed 88 39
Measure Type: Number
Unit of Measure: participants
8 4
12.Secondary Outcome
Title Maximum Change From Baseline to Endpoint on the Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) - Total Score
Hide Description A scale used to assess the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Parkinsonism is assessed by the total points of items 1 to 5; akathisia, dystonia and dyskinesia are assessed by the points given to the corresponding items.
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Overall Number of Participants Analyzed 100 39
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.35  (1.01) 0.18  (0.60)
Maximum Change from baseline to endpoint 0.05  (1.21) 0.64  (1.51)
13.Secondary Outcome
Title Number of Participants With Treatment-Emergent Parkinsonism Based on DIEPSS Scores
Hide Description DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). Parkinsonism is assessed by the total points of items 1 to 5 (total score of 0 to 20). Treatment-emergent parkinsonism was defined as a score of equal or greater than 3 on 1 item, equal or greater than 2 on 2 items, or an increase of equal or greater than 3 from baseline on the parkinsonism total.
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Included were all participants who did not have an abnormal value at baseline.
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Overall Number of Participants Analyzed 100 39
Measure Type: Number
Unit of Measure: participants
1 3
14.Secondary Outcome
Title Number of Participants With Treatment-Emergent Akathisia Based on DIEPSS Scores
Hide Description DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Treatment-emergent akathisia was defined as a score of equal or more than 2 or an increase of equal or more than 2 points from baseline on the akathisia item (total score possible 0 to 4 points).
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Included were all participants who did not have an abnormal value at baseline.
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Overall Number of Participants Analyzed 98 38
Measure Type: Number
Unit of Measure: participants
3 2
15.Secondary Outcome
Title Number of Participants With Treatment-Emergent Dystonia Based on DIEPSS Scores
Hide Description DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Treatment-emergent dystonia was defined as a score equal or more than 2 or an increase of equal or more than 2 points from baseline on the dystonia item (total score possible 0 to 4 points).
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Included were all participants who did not have an abnormal value at baseline.
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Overall Number of Participants Analyzed 100 38
Measure Type: Number
Unit of Measure: participants
0 1
16.Secondary Outcome
Title Number of Participants With Treatment-Emergent Dyskenisia Based on DIEPSS Scores
Hide Description DIEPSS assesses the extrapyramidal symptoms attributable to antipsychotics. Consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total points of 8 items are defined as DIEPSS total (0 to 32 points). The items are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. Treatment-emergent dyskenisia was defined as a score of equal or more than 2 or an increase of equal to or more than 2 points from baseline on the dyskenisia item (total score possible 0 to 4 points).
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Included were all participants who did not have an abnormal value at baseline.
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Overall Number of Participants Analyzed 100 39
Measure Type: Number
Unit of Measure: participants
0 0
17.Secondary Outcome
Title Number of Participants With Potentially Clinically Significant Changes in Laboratory Analytes
Hide Description Triglycerides: high limit equal to or more than 500 milligram/deciliter (mg/dL); Glucose (non-fasting): low limit 2.4975 mmol/liter (L); high limit 13.875 mmol/L; Glucose (fasting): low limit 2.4975 mmol/L; high limit 6.993 mmol/L.
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed were all participants without an abnormal value in the direction at baseline (for example, participants with an abnormally low value at baseline who experienced an abnormally low value at any time post baseline were not included, but were included if they experienced an abnormally high value at any time post baseline).
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Overall Number of Participants Analyzed 100 38
Measure Type: Number
Unit of Measure: participants
High triglycerides; n=100, n=38 5 2
Low glucose (non-fasting); n=64, n=28 0 0
High glucose (non-fasting); n=64, n=28 0 0
Low glucose (fasting); n=40, n=6 0 0
High glucose (fasting); n=40, n=6 3 0
18.Secondary Outcome
Title Number of Participants With Potentially Clinically Significant Changes in Vital Signs and Weight
Hide Description Low systolic blood pressure (SBP): <=90 millimeter mercury (mmHg) and decrease of >=20 mmHg; High SBP: >=180 mmHg and increase of >=20 mmHg; Low diastolic blood pressure (DBP): <=50 mmHg and decrease of >=15 mmHg; High DBP: >=105 mmHg and increase of >=15 mmHg; Low pulse: <50 beats per minute (bpm) and decrease of >=15 bpm; High pulse: >120 bpm and an increase of >=15 bpm; Low weight: decrease of >=7%; High weight: increase of >=7%;
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed were all study participants.
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Overall Number of Participants Analyzed 100 39
Measure Type: Number
Unit of Measure: participants
Low systolic blood pressure 6 2
High systolic blood pressure 0 0
Low diastolic blood pressure 4 1
High diastolic blood pressure 1 0
Low weight 3 1
High weight 17 10
Low pulse 0 0
High pulse 0 0
19.Secondary Outcome
Title Number of Participants With Potentially Clinically Significant Changes in Electrocardiograms - High Fridericia Corrected QT Interval (QTcF)
Hide Description High QTcF: more than or equal to 450 milliseconds (msec) for males; more than or equal to 470 milliseconds (msec) for females
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed were all participants who had baseline and post-baseline measurements and no abnormal values in the direction at baseline (e.g. participants with an abnormally low value for a given parameter at baseline who showed an abnormally low value for the same parameter at a later visit were not included). Last observation carried forward.
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Overall Number of Participants Analyzed 97 39
Measure Type: Number
Unit of Measure: participants
0 0
20.Secondary Outcome
Title Number of Participants With Treatment-emergent Abnormal, High, or Low Laboratory Values
Hide Description High density lipoprotein: males low 40 milligram/deciliter (mg/dL), high 80 mg/dL; females low 40 mg/dL, high 90 mg/dL. Low density lipoprotein (LDL): males and females low 70 mg/dL, high 139 mg/dL. Hemoglobin A1C (HBA1C): males and females low 4.3%, high 5.8%.
Time Frame baseline through 18 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed were all participants who had baseline and post-baseline measurements. Last observation carried forward.
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description:
Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
Overall Number of Participants Analyzed 100 39
Measure Type: Number
Unit of Measure: participants
Low high density lipoprotein (HDL); n=93, n=36 10 3
High high density lipoprotein (HDL); n=95, n=37 5 1
Low low density lipoprotein (LDL); n=97; n=37 1 1
High low density lipoprotein (LDL); n=71, n=31 24 11
Low hemoglobin A1C (HBA1C); n=100, n=39 1 1
High hemoglobin A1C (HBA1C); n=97, n=38 2 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Hide Arm/Group Description Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks. Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
All-Cause Mortality
Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/100 (1.00%)      0/39 (0.00%)    
Injury, poisoning and procedural complications     
Radius fracture  1  1/100 (1.00%)  1 0/39 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Olanzapine Monotherapy Olanzapine + Mood Stabilizer
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   59/100 (59.00%)      31/39 (79.49%)    
Gastrointestinal disorders     
Constipation  1  3/100 (3.00%)  3 3/39 (7.69%)  3
General disorders     
Thirst  1  5/100 (5.00%)  5 2/39 (5.13%)  2
Infections and infestations     
Nasopharyngitis  1  17/100 (17.00%)  19 6/39 (15.38%)  6
Injury, poisoning and procedural complications     
Contusion  1  2/100 (2.00%)  3 2/39 (5.13%)  2
Fall  1  0/100 (0.00%)  0 2/39 (5.13%)  4
Investigations     
Alanine aminotransferase increased  1  2/100 (2.00%)  2 3/39 (7.69%)  3
Blood cholesterol increased  1  3/100 (3.00%)  3 3/39 (7.69%)  3
Blood triglycerides increased  1  5/100 (5.00%)  5 6/39 (15.38%)  6
Gamma-glutamyltransferase increased  1  0/100 (0.00%)  0 2/39 (5.13%)  2
Low density lipoprotein increased  1  1/100 (1.00%)  1 2/39 (5.13%)  2
Weight increased  1  9/100 (9.00%)  9 5/39 (12.82%)  5
Nervous system disorders     
Somnolence  1  15/100 (15.00%)  15 7/39 (17.95%)  8
Psychiatric disorders     
Depressive symptom  1  7/100 (7.00%)  7 2/39 (5.13%)  2
Skin and subcutaneous tissue disorders     
Dermatitis contact  1  0/100 (0.00%)  0 2/39 (5.13%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Layout table for additonal information
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00266630     History of Changes
Other Study ID Numbers: 9637
F1D-JE-BMEX ( Other Identifier: Eli Lilly and Company )
First Submitted: December 15, 2005
First Posted: December 19, 2005
Results First Submitted: May 26, 2010
Results First Posted: June 29, 2010
Last Update Posted: December 28, 2010