Bipolar Disorder Study for Men and Women

April 6, 2017 updated by: GlaxoSmithKline

Double Blind Placebo Controlled Study of Lamictal in Acute Bipolar Depression

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90210
        • GSK Investigational Site
      • La Jolla, California, United States, 92093
        • GSK Investigational Site
      • San Diego, California, United States, 92108
        • GSK Investigational Site
      • Santa Ana, California, United States, 92705
        • GSK Investigational Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • GSK Investigational Site
    • Indiana
      • Terre Haute, Indiana, United States, 47802
        • GSK Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • GSK Investigational Site
    • Missouri
      • St. Charles, Missouri, United States, 63301
        • GSK Investigational Site
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • GSK Investigational Site
    • New York
      • New York, New York, United States, 10021
        • GSK Investigational Site
      • Pleasantville, New York, United States, 10570
        • GSK Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • GSK Investigational Site
    • Ohio
      • Brecksville, Ohio, United States, 44141
        • GSK Investigational Site
      • Cincinnati, Ohio, United States, 45242
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44106
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
      • Portland, Oregon, United States, 97210
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • GSK Investigational Site
    • Texas
      • San Antonio, Texas, United States, 77090
        • GSK Investigational Site
    • Wisconsin
      • Brown Deer, Wisconsin, United States, 53223
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1
Drug: lamotrigine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline scores at Week 8 for the Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame: 8 Weeks
8 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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: 8 Weeks
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 27, 2003

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

December 14, 2005

Study Registration Dates

First Submitted

March 10, 2003

First Submitted That Met QC Criteria

March 10, 2003

First Posted (Estimate)

March 11, 2003

Study Record Updates

Last Update Posted (Actual)

April 7, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCA30924

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Annotated Case Report Form
    Information identifier: SCA30924
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Informed Consent Form
    Information identifier: SCA30924
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistical Analysis Plan
    Information identifier: SCA30924
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Dataset Specification
    Information identifier: SCA30924
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Individual Participant Data Set
    Information identifier: SCA30924
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Study Protocol
    Information identifier: SCA30924
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Clinical Study Report
    Information identifier: SCA30924
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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