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Depression And Bipolar Disorder

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00274677
Collaborator
(none)
221
Enrollment
19
Locations
2
Arms
21
Duration (Months)
11.6
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
221 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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
Study Start Date :
Nov 1, 2003
Actual Primary Completion Date :
Aug 1, 2005
Actual Study Completion Date :
Aug 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Drug: lamotrigine
Experimental treatment
Other Names:
  • Placebo

    		•
    Experimental: lamotrigine

    Drug: Placebo
    Experimental treatment arm

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GSK Investigational Site Burbank California United States 91506
    2 GSK Investigational Site Loma Linda California United States 92354
    3 GSK Investigational Site San Diego California United States 92108
    4 GSK Investigational Site Marietta Georgia United States 30060
    5 GSK Investigational Site Terre Haute Indiana United States 47802
    6 GSK Investigational Site Shreveport Louisiana United States 71101
    7 GSK Investigational Site St. Charles Missouri United States 63301
    8 GSK Investigational Site Clementon New Jersey United States 08021
    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 Charlotte North Carolina United States 28209
    13 GSK Investigational Site Raleigh North Carolina United States 27609
    14 GSK Investigational Site Beachwood Ohio United States 44122
    15 GSK Investigational Site Oklahoma City Oklahoma United States 73118
    16 GSK Investigational Site Eugene Oregon United States 97401
    17 GSK Investigational Site Columbia South Carolina United States 29201
    18 GSK Investigational Site Galveston Texas United States 77555-0188
    19 GSK Investigational Site Houston Texas United States 77090

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT00274677
    Other Study ID Numbers:
    • SCA100223
    • NCT00076882
    First Posted:
    Jan 11, 2006
    Last Update Posted:
    Sep 15, 2016
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by GlaxoSmithKline
    Bipolar Disorder
    Additional relevant MeSH terms:
    Disease
    Bipolar Disorder
    Lamotrigine

    Study Results

    No Results Posted as of Sep 15, 2016