Bipolar Disorder Study for Men and Women

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: lamotrigine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00056277

SCA30924

Details and patient eligibility

About

A Placebo Controlled Study Evaluating Efficacy and Safety of Medication in Patients with Bipolar Disorder

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 1 patient group

Arm 1

Other group

Treatment:

Drug: lamotrigine