Last updated: 11/04/2018 11:36:09

Clinical Study Of Schizophrenia in Both Men and Women

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GSK study ID
SCA30926
See study documents
Clinicaltrials.gov ID
NCT00071747
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 Multi-Center, Double blind, Placebo-controlled, Randomized, Parallel Group Evaluation of the Efficacy of a Flexible Dose of Lamotrigine versus Placebo As Add-On Therapy In Schizophrenia
Trial description: The objective of this study is to evaluate the effectiveness of a marketed drug in the treatment of schizophrenia, as an add-on therapy to antipsychotics over a 12-week period. Subjects with schizophrenia who have been maintained on a stable dose of antipsychotics and who fulfill the screening entrance criteria will have an assessment 1-7 days after the first visit to confirm eligibility.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Change from baseline in the total score of the 7 items of the Positive and Negative Symptom Scale (PANSS) positive symptom subscale for lamotrigine vs. placebo at Week 12.

Timeframe: 12 Weeks

Secondary outcomes:

Change from baseline in the PANSS total score at Week 12; Change from baseline in the Scale for the Assessment of Negative Symptoms (SANS) at Week 12; Change from baseline in the Clinical Global Impression-Severity of Illness (CGI-S) score at Week 12.

Timeframe: 12 Weeks

Interventions:
  • Drug: lamotrigine
    • Enrollment:
    176
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Goff DC. Keefe R. Citrome L. Davy K. Krystal JH. Large C. Thompson TR. Volavka J. Webster EL. Lamotrigine as add-on therapy in schizophrenia - Results of 2 placebo-controlled trials. Journal of Clinical Psychopharmacology. 27(6):582-589, 2007 Dec.
    Medical condition
    Schizophrenia
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    August 2003 to January 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.
    • Diagnosis of Schizophrenia
    • Patients must be taking clozapine monotherapy or other atypical antipsychotic at least 3 months prior to this study. Exclusion criteria:
    • Patients who are currently taking or have taken antidepressant medication in the last month prior.
    • Patients who are or have been suicidal or homicidal in the last 6 months.
    • Patients with a history of autistic disorder or another pervasive developmental disorder
    • Patients whose condition is due to the direct physiological effects of a substance (e.g. a drug of abuse, a medication) or a general medical condition

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Bellaire, Texas, United States, 77401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hartford, Connecticut, United States, 06106
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    National City, California, United States, 91950
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Oceanside, California, United States, 92056
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Orangeburg, New York, United States, 10962
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Garden Grove, California, United States, 92845
    Status
    Study Complete
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    Showing 1 - 6 of 32 Results

    Study documents

    Clinical study report
    Available language(s): English
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    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
    2005-27-01

    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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