Bipolar Disorder
Conditions
Keywords
Bipolar Disorder
Brief summary
This study is an 8-week evaluation of an investigational drug for treating depression in bipolar patients. Depressed patients will be given either an investigational drug or placebo and receive psychiatric assessments of their depression at weekly visits. Study drug and all study-related visits are provided at no cost to the patient. The patient agrees to meet with study research staff for roughly 11 clinic visits.
Interventions
DRUGPlacebo
Experimental treatment arm
DRUGlamotrigine
Experimental treatment
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
Inclusion * Patients must provide written and informed consent. * Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks. Exclusion * Patients must not be suicidal. * Patients must not have a history of 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) | Eight 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) | Eight weeks |
Countries
United States
Outcome results
None listed