CompletedPhase 3

Depression And Bipolar Disorder

United States221 participantsStarted 2003-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS)

Timeframe: Eight weeks

Trial details

NCT IDNCT00274677

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-08

View on ClinicalTrials.gov More Bipolar Disorder trials