Clinical Study Of Schizophrenia in Both Men and Women

August 30, 2016 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

176

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

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72201
        • GSK Investigational Site
    • California
      • Garden Grove, California, United States, 92845
        • GSK Investigational Site
      • La Mesa, California, United States, 91942
        • GSK Investigational Site
      • National City, California, United States, 91950
        • GSK Investigational Site
      • Oceanside, California, United States, 92056
        • GSK Investigational Site
      • Rosemead, California, United States, 91770
        • GSK Investigational Site
      • San Diego, California, United States, 92126
        • GSK Investigational Site
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • GSK Investigational Site
    • Florida
      • Maitland, Florida, United States, 32751
        • GSK Investigational Site
      • North Miami, Florida, United States, 33161
        • GSK Investigational Site
    • Illinois
      • Granite City, Illinois, United States, 62040
        • GSK Investigational Site
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • GSK Investigational Site
      • Rockville, Maryland, United States, 20852
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • GSK Investigational Site
    • Nevada
      • Reno, Nevada, United States, 89512
        • GSK Investigational Site
    • New Jersey
      • Clementon, New Jersey, United States, 08021
        • GSK Investigational Site
      • Kenilworth, New Jersey, United States, 07033
        • GSK Investigational Site
    • New York
      • Orangeburg, New York, United States, 10962
        • GSK Investigational Site
      • Rochester, New York, United States, 14620
        • GSK Investigational Site
    • North Carolina
      • Butner, North Carolina, United States, 27509
        • GSK Investigational Site
      • Charlotte, North Carolina, United States, 28211
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27609
        • GSK Investigational Site
      • Raleigh, North Carolina, United States, 27603
        • GSK Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44106
        • GSK Investigational Site
      • Lyndhurst, Ohio, United States, 44124
        • GSK Investigational Site
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19401
        • GSK Investigational Site
    • Texas
      • Austin, Texas, United States, 78756
        • GSK Investigational Site
      • Bellaire, Texas, United States, 77401
        • GSK Investigational Site
      • DeSoto, Texas, United States, 75115
        • GSK Investigational Site
    • Utah
      • Midvale, Utah, United States, 84047
        • GSK Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • 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:

  • 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

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 7 items of the Positive and Negative Symptom Scale (PANSS) positive symptom subscale for lamotrigine vs. placebo at Week 12.
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.

General Publications

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

August 1, 2003

Study Completion (Actual)

January 1, 2005

Study Registration Dates

First Submitted

October 30, 2003

First Submitted That Met QC Criteria

October 30, 2003

First Posted (Estimate)

October 31, 2003

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCA30926

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. Informed Consent Form
    Information identifier: SCA30926
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Dataset Specification
    Information identifier: SCA30926
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: SCA30926
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Individual Participant Data Set
    Information identifier: SCA30926
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Clinical Study Report
    Information identifier: SCA30926
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistical Analysis Plan
    Information identifier: SCA30926
    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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