Last updated: 11/04/2018 11:33:27

Depression And Bipolar Disorder

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GSK study ID
SCA100223
See study documents
Clinicaltrials.gov ID
NCT00274677
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

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

Timeframe: Eight weeks

Secondary outcomes:

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)

Timeframe: Eight weeks

Interventions:
  • Drug: Placebo
  • Drug: lamotrigine
    • Enrollment:
    221
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Bipolar Disorder
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    November 2003 to August 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion
    • Patients must provide written and informed consent.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • 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.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77090
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Princeton, New Jersey, United States, 08540
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Terre Haute, Indiana, United States, 47802
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New York, New York, United States, 10021
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92108
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27609
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Shreveport, Louisiana, United States, 71101
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Marietta, Georgia, United States, 30060
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Eugene, Oregon, United States, 97401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Loma Linda, California, United States, 92354
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Burbank, California, United States, 91506
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73118
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Galveston, Texas, United States, 77555-0188
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Charles, Missouri, United States, 63301
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Clementon, New Jersey, United States, 08021
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Columbia, South Carolina, United States, 29201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlotte, North Carolina, United States, 28209
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Beachwood, Ohio, United States, 44122
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Pleasantville, New York, United States, 10570
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2005-26-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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