Bipolar Disorder
Conditions
Brief summary
A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder
Interventions
DRUGlamotrigine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) | 8 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed