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

October 5, 2016 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

209

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2C8
        • GSK Investigational Site
      • Edmonton, Alberta, Canada, T5K 2J5
        • GSK Investigational Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1W 4V5
        • GSK Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3N4
        • GSK Investigational Site
    • New Brunswick
      • Miramichi, New Brunswick, Canada, E1V 3G5
        • GSK Investigational Site
    • Nova Scotia
      • Dartmouth, Nova Scotia, Canada, B2Y 3S3
        • GSK Investigational Site
      • Sydney, Nova Scotia, Canada, B1S 2E8
        • GSK Investigational Site
    • Ontario
      • Burlington, Ontario, Canada, L7N 3V2
        • GSK Investigational Site
      • London, Ontario, Canada, N6A 4G5
        • GSK Investigational Site
      • Mississauga, Ontario, Canada, L5M 4N4
        • GSK Investigational Site
      • Sudbury, Ontario, Canada, P3E 1X3
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M6M 3Z5
        • GSK Investigational Site
      • Windsor, Ontario, Canada, N9C 3Z4
        • GSK Investigational Site
  • United Kingdom
      • Hull, United Kingdom, HU6 7RX
        • GSK Investigational Site
    • Bedfordshire
      • Bedford, Bedfordshire, United Kingdom, MK42 9DJ
        • GSK Investigational Site
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB1 5EF
        • GSK Investigational Site
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G66 3UG
        • GSK Investigational Site
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV2 2DX
        • GSK Investigational Site
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
        • GSK Investigational Site
    • California
      • Garden Grove, California, United States, 92845
        • GSK Investigational Site
      • Glendale, California, United States, 91206
        • GSK Investigational Site
      • Los Angeles, California, United States, 90033
        • GSK Investigational Site
      • Pico Rivera, California, United States, 90660
        • GSK Investigational Site
      • San Diego, California, United States, 92126
        • GSK Investigational Site
      • Sherman Oaks, California, United States, 91403
        • GSK Investigational Site
    • Florida
      • Coral Springs, Florida, United States, 33065
        • GSK Investigational Site
      • Maitland, Florida, United States, 32751
        • GSK Investigational Site
      • Miami, Florida, United States, 33125
        • GSK Investigational Site
      • North Miami, Florida, United States, 33161
        • GSK Investigational Site
      • Winter Park, Florida, United States, 32789
        • GSK Investigational Site
    • Illinois
      • Niles, Illinois, United States, 60714
        • GSK Investigational Site
      • Oak Brook, Illinois, United States, 60523
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • GSK Investigational Site
      • Indianapolis, Indiana, United States, 46202-5200
        • GSK Investigational Site
    • New York
      • Staten Island, New York, United States, 10305
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • GSK Investigational Site
    • Texas
      • Bellaire, Texas, United States, 77401
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53711-2027
        • 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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
- 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.
Time Frame: 12 Weeks
12 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.

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

May 1, 2004

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

July 6, 2004

First Submitted That Met QC Criteria

July 7, 2004

First Posted (Estimate)

July 8, 2004

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 5, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 101464

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: 101464
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: 101464
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Informed Consent Form
    Information identifier: 101464
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistical Analysis Plan
    Information identifier: 101464
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: 101464
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individual Participant Data Set
    Information identifier: 101464
    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.

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