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NCT00056277 Clinical Trial

Bipolar Disorder Study for Men and Women

Bipolar Disorder Clinical Trial

Official title:
Double Blind Placebo Controlled Study of Lamictal in Acute Bipolar Depression

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00056277
Other study ID # SCA30924
Secondary ID
Status Completed
Phase Phase 3
First received March 10, 2003
Last updated April 6, 2017
Start date February 27, 2003
Est. completion date December 14, 2005

Study information
Verified date April 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date December 14, 2005
Est. primary completion date August 1, 2005
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• lamotrigine

Locations
Country Name City State
United States GSK Investigational Site Beverly Hills California
United States GSK Investigational Site Brecksville Ohio
United States GSK Investigational Site Brown Deer Wisconsin
United States GSK Investigational Site Cincinnati Ohio
United States GSK Investigational Site Cleveland Ohio
United States GSK Investigational Site Columbia South Carolina
United States GSK Investigational Site Eugene Oregon
United States GSK Investigational Site La Jolla California
United States GSK Investigational Site Marietta Georgia
United States GSK Investigational Site New York New York
United States GSK Investigational Site Pleasantville New York
United States GSK Investigational Site Portland Oregon
United States GSK Investigational Site Princeton New Jersey
United States GSK Investigational Site Raleigh North Carolina
United States GSK Investigational Site San Antonio Texas
United States GSK Investigational Site San Diego California
United States GSK Investigational Site Santa Ana California
United States GSK Investigational Site Shreveport Louisiana
United States GSK Investigational Site St. Charles Missouri
United States GSK Investigational Site Terre Haute Indiana

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS) 8 Weeks
Secondary 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
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