Depression And Bipolar Disorder

September 13, 2016 updated by: GlaxoSmithKline

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

221

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
      • Burbank, California, United States, 91506
        • GSK Investigational Site
      • Loma Linda, California, United States, 92354
        • GSK Investigational Site
      • San Diego, California, United States, 92108
        • 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
      • Clementon, New Jersey, United States, 08021
        • GSK Investigational Site
      • 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
      • Charlotte, North Carolina, United States, 28209
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • GSK Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • GSK Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29201
        • GSK Investigational Site
    • Texas
      • Galveston, Texas, United States, 77555-0188
        • GSK Investigational Site
      • Houston, Texas, United States, 77090
        • 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

  • 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 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
Placebo Comparator: Placebo
Drug: lamotrigine
Experimental treatment
Other Names:
  • Placebo
Experimental: lamotrigine
Drug: Placebo
Experimental treatment arm

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: Eight weeks
Eight 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: Eight weeks
Eight 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

November 1, 2003

Primary Completion (Actual)

August 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

January 9, 2006

First Submitted That Met QC Criteria

January 10, 2006

First Posted (Estimate)

January 11, 2006

Study Record Updates

Last Update Posted (Estimate)

September 15, 2016

Last Update Submitted That Met QC Criteria

September 13, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCA100223

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. Study Protocol
    Information identifier: SCA100223
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individual Participant Data Set
    Information identifier: SCA100223
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annotated Case Report Form
    Information identifier: SCA100223
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: SCA100223
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: SCA100223
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Clinical Study Report
    Information identifier: SCA100223
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Dataset Specification
    Information identifier: SCA100223
    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.

Clinical Trials on Bipolar Disorder

Clinical Trials on lamotrigine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe