Bipolar Study in Adults at Least 18 Years of Age

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Bipolar Disorder

Treatments: Drug: lamotrigine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00067938

SCA40917

Details and patient eligibility

About

Bipolar study of tolerability, clinical response and patient satisfaction

Enrollment: 1,200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of bipolar I disorder.
• Must be on a stable regimen of psychiatric medication for at least 2 months prior to study.
• If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.

Exclusion criteria

• Patients with a clinically significant psychiatric or physiologic comorbidity including significant substance abuse, depression or mania which is of an unstable of progressive nature that could interfere in participation of this study.
• Presence of untreated thyroid disease.
• Patient is actively suicidal or homicidal.
• Patient has history of severe hepatic or renal insufficiency.
• Patient is currently participating in another clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,200 participants in 1 patient group

Arm 1

Other group

Description:

Open label single arm study

Treatment:

Drug: lamotrigine