Depression And Bipolar Disorder

Bipolar Disorder Clinical Trial

Official title:

A Multicenter, Double-Blind, Placebo-Controlled, Fixed-Dose, 8-Week Evaluation of the Efficacy and Safety of Lamotrigine in the Treatment of Depression in Patients With Type II Bipolar Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00274677
• Other study ID #: SCA100223
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2006
• Last updated: September 13, 2016
• Start date: November 2003
• Est. completion date: August 2005

Study information

• Verified date: September 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT00076882

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: August 2005
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Disease

Intervention

Drug:
• Placebo
Experimental treatment arm
• lamotrigine
Experimental treatment

Locations

Country	Name	City	State
United States	GSK Investigational Site	Beachwood	Ohio
United States	GSK Investigational Site	Burbank	California
United States	GSK Investigational Site	Charlotte	North Carolina
United States	GSK Investigational Site	Clementon	New Jersey
United States	GSK Investigational Site	Columbia	South Carolina
United States	GSK Investigational Site	Eugene	Oregon
United States	GSK Investigational Site	Galveston	Texas
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Loma Linda	California
United States	GSK Investigational Site	Marietta	Georgia
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Pleasantville	New York
United States	GSK Investigational Site	Princeton	New Jersey
United States	GSK Investigational Site	Raleigh	North Carolina
United States	GSK Investigational Site	San Diego	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)		Eight weeks	No
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)		Eight weeks	No

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.