Last updated: 11/06/2018 23:36:20

Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia

Request patient level data
GSK study ID
101464
See study documents
Clinicaltrials.gov ID
NCT00086593
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, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of a Flexible Dose of Lamotrigine Compared to Placebo as an Adjunctive Therapy to an Atypical Antipsychotic Agent(s) in Subjects with Schizophrenia
Trial description: This is a 12-week study for the treatment of chronic persistent symptoms in participants with schizophrenia. Participants on a stable, optimal dose of up to two atypical antipsychotics who fulfill the screening criteria will be randomized to receive either an FDA-approved drug or placebo in addition to the current treatment. Safety will be closely monitored through vital signs, various tests, and blood and urine samples.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.

Timeframe: 12 Weeks

Secondary outcomes:

- Efficacy - Change from baseline in PANSS positive symptoms at Week 12 - Change from baseline in the Scale for the Assessment of Negative Symptoms (SANS) at Week 12 - Change from baseline in PANSS general psychopathology symptoms at Week 12.

Timeframe: 12 Weeks

Interventions:
  • Drug: lamotrigine
    • Enrollment:
    209
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Donald C. Goff, MD Richard Keefe, PhD Leslie Citrome, MD Katherine Davy, MSc John Krystal, MD Charles Large, PhD Jan Volavka, MD Elizabeth L. Webster, PhD . Lamotrigine as Add-on Therapy in Schizophrenia: Results of Two Placebo-Controlled Trials. J Clin Psychopharmacol. 2007;27(6):582-589.
    Medical condition
    Schizophrenia
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    May 2004 to July 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosed with schizophrenia.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Diagnosed with schizophrenia.
    • Exhibits persistent positive symptoms that have persisted for a minimum of 3 months prior to screening.
    • Continuously taking 1-2 specific atypical antipsychotics for a minimum of 3 months and must be on a stable dose for at least 1 month prior to entering the study.
    • Participant or a legal guardian is able to understand and sign the consent form. Exclusion criteria:
    • PANSS (Positive and Negative Syndrome Score) total score increases or decreases by more than 20% between the Screening and Baseline visits.
    • Predominant Axis I disorder other than schizophrenia within 6 months prior to screening.
    • History of clinically significant or unstable medical disorder or treatment that would interfere with the study.
    • History of autistic disorder or another pervasive developmental disorder, organic brain disease, dementia, stroke, epilepsy or a history of seizures requiring treatment (this does not include febrile seizures as a child), or those who have suffered a traumatic head injury.
    • Taking psychotropic or primarily centrally active medication at screening.
    • Use of antidepressant medications or mood stabilizers within 1 month of screening.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Dartmouth, Nova Scotia, Canada, B2Y 3S3
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Toronto, Ontario, Canada, M6M 3Z5
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Diego, California, United States, 92126
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Bellaire, Texas, United States, 77401
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Maitland, Florida, United States, 32751
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 38 Results

    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
    Not applicable

    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

    Participate in clinical trial
    Additional information
    Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
    Click here
    Access to clinical trial data by researchers
    Visit website