Double Blind Placebo Controlled Study of Lamictal in Acute Bipolar Depression

GlaxoSmithKline1 site in 1 country150 target enrollmentFebruary 27, 2003

Interventionslamotrigine

Overview

Phase: Phase 3
Intervention: lamotrigine
Conditions: Bipolar Disorder
Sponsor: GlaxoSmithKline
Enrollment: 150
Locations: 1
Primary Endpoint: Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS)
Status: Completed
Last Updated: 9 years ago

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

Registry

clinicaltrials.gov

Start Date

February 27, 2003

End Date

December 14, 2005

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•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

•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

Intervention: lamotrigine

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

Time Frame: 8 Weeks

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).(8 Weeks)