Depression And Bipolar Disorder

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Bipolar Disorder

Treatments

Drug: lamotrigine

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00274677

SCA100223

Details and patient eligibility

About

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.

Enrollment

221 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.