Bipolar Disorder Study for Men and Women

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00056277

Collaborator

(none)

150

Enrollment

Locations

Arm

33.5

Duration (Months)

7.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder	Drug: lamotrigine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Double Blind Placebo Controlled Study of Lamictal in Acute Bipolar Depression

Study Start Date :

Feb 27, 2003

Actual Primary Completion Date :

Aug 1, 2005

Actual Study Completion Date :

Dec 14, 2005

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm 1	Drug: lamotrigine

Arm

Intervention/Treatment

Other: Arm 1

Drug: lamotrigine

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Beverly Hills	California	United States	90210
2	GSK Investigational Site	La Jolla	California	United States	92093
3	GSK Investigational Site	San Diego	California	United States	92108
4	GSK Investigational Site	Santa Ana	California	United States	92705
5	GSK Investigational Site	Marietta	Georgia	United States	30060
6	GSK Investigational Site	Terre Haute	Indiana	United States	47802
7	GSK Investigational Site	Shreveport	Louisiana	United States	71101
8	GSK Investigational Site	St. Charles	Missouri	United States	63301
9	GSK Investigational Site	Princeton	New Jersey	United States	08540
10	GSK Investigational Site	New York	New York	United States	10021
11	GSK Investigational Site	Pleasantville	New York	United States	10570
12	GSK Investigational Site	Raleigh	North Carolina	United States	27609
13	GSK Investigational Site	Brecksville	Ohio	United States	44141
14	GSK Investigational Site	Cincinnati	Ohio	United States	45242
15	GSK Investigational Site	Cleveland	Ohio	United States	44106
16	GSK Investigational Site	Eugene	Oregon	United States	97401
17	GSK Investigational Site	Portland	Oregon	United States	97210
18	GSK Investigational Site	Columbia	South Carolina	United States	29201
19	GSK Investigational Site	San Antonio	Texas	United States	77090
20	GSK Investigational Site	Brown Deer	Wisconsin	United States	53223

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00056277

Other Study ID Numbers:

SCA30924

First Posted:

Mar 11, 2003

Last Update Posted:

Apr 7, 2017

Last Verified:

Apr 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Bipolar Disorder

Lamotrigine

Study Results

No Results Posted as of Apr 7, 2017