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An Evaluation Of BW430C (Lamotrigine) Versus Placebo In The Prevention Of Mood Episodes In Bipolar I Disorder Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00550407
First received: October 26, 2007
Last updated: May 31, 2012
Last verified: June 2011
History of Changes
Results First Received: May 24, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Interventions: Drug: lamotrigine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants whose symptoms of mood episodes were stabilized with lamotrigine in the Preliminary Phase (Clinical Global Impressions of Severity score of 3 [mild] or less for at least 4 consecutive weeks, and lamotrigine given as monotherapy for at least 1 week before the start of the Randomized Phase) were randomized to placebo or lamotrigine.

Reporting Groups
  Description
Lamotrigine 25-200 mg The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
Placebo Matching placebo
Lamotrigine 200 mg Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.

Participant Flow for 2 periods

 Period 1:   8-16 Week Preliminary (Open-Label) Phase
    Lamotrigine 25-200 mg     Placebo     Lamotrigine 200 mg  
STARTED     215     0     0  
COMPLETED     103     0     0  
NOT COMPLETED     112     0     0  
Adverse Event                 55                 0                 0  
Lack of Efficacy                 39                 0                 0  
Protocol Violation                 1                 0                 0  
Defined Stopping Criteria Reached                 1                 0                 0  
Lost to Follow-up                 1                 0                 0  
Investigator Discretion                 8                 0                 0  
Withdrew Consent                 6                 0                 0  
Continuation Criteria Not Met                 1                 0                 0  

Period 2:   26-Week Randomized Phase
    Lamotrigine 25-200 mg     Placebo     Lamotrigine 200 mg  
STARTED     0     58     45  
COMPLETED     0     15     21  
NOT COMPLETED     0     43     24  
Adverse Event                 0                 5                 2  
Lack of Efficacy                 0                 36                 19  
Investigator Discretion                 0                 1                 0  
Withdrawal by Subject                 0                 1                 3  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Matching placebo
Lamotrigine 200 mg Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
Total Total of all reporting groups

Baseline Measures
    Placebo     Lamotrigine 200 mg     Total  
Number of Participants  
[units: participants]
 		  58     45     103  
Age  
[units: years]
Mean ± Standard Deviation 		  43.1  ± 12.68     42.4  ± 11.79     42.8  ± 12.25  
Gender  
[units: participants]
 		     
Female     31     27     58  
Male     27     18     45  
Race/Ethnicity, Customized  
[units: participants]
 		     
Asian－Japanese Heritage     58     44     102  
Asian－East Asian Heritage     0     1     1  



  Outcome Measures
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1.  Primary:   Time to Withdrawal From Study   [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]
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2.  Secondary:   Time to Intervention for Any Mood Episode (TIME)   [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]
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3.  Secondary:   Time to Intervention for Depressive Episode (TIDep)   [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]
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4.  Secondary:   Time to Intervention for Manic, Hypomanic, or Mixed Episode (TIMan)   [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]
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5.  Secondary:   Clinical Global Impressions of Improvement (CGI-I) at Week 26/Withdrawal (Randomized Phase)   [ Time Frame: Week 26/Withdrawal ]
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6.  Secondary:   Clinical Global Impressions of Improvement (CGI-I) at Week 16/Withdrawal (Preliminary Phase)   [ Time Frame: Week 16/Withdrawal ]
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7.  Secondary:   Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 26/Withdrawal (Randomized Phase)   [ Time Frame: Baseline and Week 26/Withdrawal ]
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8.  Secondary:   Change From Baseline in Clinical Global Impressions of Severity (CGI-S) Scores at Week 16/Withdrawal (Preliminary Phase)   [ Time Frame: Baseline and Week 16/Withdrawal ]
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9.  Secondary:   Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 26/Withdrawal (Randomized Phase)   [ Time Frame: Baseline and Week 26/Withdrawal ]
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10.  Secondary:   Change From Baseline in Hamilton Rating Scale for Depression (HAMD-17) Scores at Week 16/Withdrawal (Preliminary Phase)   [ Time Frame: Baseline and Week 16/Withdrawal ]
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11.  Secondary:   Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 26/Withdrawal (Randomized Phase)   [ Time Frame: Baseline and Week 26/Withdrawal ]
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12.  Secondary:   Change From Baseline in Young Mania Rating Scale (YMRS) Total Scores at Week 16/Withdrawal (Preliminary Phase)   [ Time Frame: Baseline and Week 16/Withdrawal ]
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13.  Post-Hoc:   Number of Participants With a Withdrawal Event   [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]
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14.  Post-Hoc:   Number of Participants With Intervention for Any Mood Episode   [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]
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15.  Post-Hoc:   Number of Participants With Intervention for Depressive Episode   [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]
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16.  Post-Hoc:   Number of Participants With Intervention for a Manic, Hypomanic, or Mixed Episode   [ Time Frame: Randomization to Study Withdrawal (up to Week 26) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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