Bipolar Disorder Study for Men and Women
- Registration Number
- NCT00056277
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Patients must provide written and informed consent
- Diagnosis of Bipolar I Disorder and currently depressed for minimum of the previous 8 weeks
- Patients must have been hospitalized for mood disorder or incarceration with or without formal charges as the result of mania related behavior
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Exclusion Criteria
- Patients must not be suicidal
- Patients must not have a history or non-response to antidepressant treatment
- Patients must not have a clinical history of substance dependence in the past year or abuse within the 4 weeks prior to study entry
- Patients must not have had epilepsy or hypothyroidism
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 lamotrigine -
- Primary Outcome Measures
Name Time Method Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) 8 Weeks
- Secondary Outcome Measures
Name Time Method Change from baseline scores at Week 8 for the Hamilton Depression Rating Scale (HAMD-17, HAMD-31, Bech Melancholia Scale (BMS), and HAMD - Item 1), Clinical Global Impressions of Severity (CGI-S) and Improvement (CGI-I). 8 Weeks
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Brown Deer, Wisconsin, United States