Depression And Bipolar Disorder

GlaxoSmithKline221 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

221

Conditions

Bipolar Disorder

Interventions

PlaceboDRUG

Experimental treatment arm

lamotrigineDRUG

Experimental treatment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (19)

GSK Investigational Site

Burbank, California, United States

GSK Investigational Site

Loma Linda, California, United States

Outcomes

Primary Outcomes

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

Time frame: Eight weeks

Secondary Outcomes

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)

Time frame: Eight weeks

Data from ClinicalTrials.gov

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