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Study Of An FDA-Approved Drug As Additional Therapy In Patients With Schizophrenia
This study has been completed.
First Received: July 6, 2004   Last Updated: May 15, 2009   History of Changes
Sponsor: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00086593
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: lamotrigine
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • - 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 ]

Estimated Enrollment: 210
Study Start Date: May 2004
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086593

  Hide Study Locations
Locations
United States, Arkansas
GSK Investigational Site
Little Rock, Arkansas, United States, 72201
United States, California
GSK Investigational Site
Garden Grove, California, United States, 92845
GSK Investigational Site
Sherman Oaks, California, United States, 91403
GSK Investigational Site
Pico Rivera, California, United States, 90660
GSK Investigational Site
Glendale, California, United States, 91206
GSK Investigational Site
San Diego, California, United States, 92126
GSK Investigational Site
Los Angeles, California, United States, 90033
United States, Florida
GSK Investigational Site
North Miami, Florida, United States, 33161
GSK Investigational Site
Maitland, Florida, United States, 32751
GSK Investigational Site
Coral Springs, Florida, United States, 33065
GSK Investigational Site
Miami, Florida, United States, 33125
GSK Investigational Site
Winter Park, Florida, United States, 32789
United States, Illinois
GSK Investigational Site
Oak Brook, Illinois, United States, 60523
GSK Investigational Site
Niles, Illinois, United States, 60714
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
GSK Investigational Site
Indianapolis, Indiana, United States, 46202-5200
United States, New York
GSK Investigational Site
Staten Island, New York, United States, 10305
United States, Tennessee
GSK Investigational Site
Nashville, Tennessee, United States, 37203
United States, Texas
GSK Investigational Site
Bellaire, Texas, United States, 77401
GSK Investigational Site
San Antonio, Texas, United States, 78229
United States, Wisconsin
GSK Investigational Site
Madison, Wisconsin, United States, 53711-2027
Canada, Alberta
GSK Investigational Site
Edmonton, Alberta, Canada, T5K 2J5
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3E 3N4
Canada, New Brunswick
GSK Investigational Site
Miramichi, New Brunswick, Canada, E1V 3G5
Canada, Nova Scotia
GSK Investigational Site
Dartmouth, Nova Scotia, Canada, B2Y 3S3
GSK Investigational Site
Sydney, Nova Scotia, Canada, B1S 2E8
Canada, Ontario
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 1X3
GSK Investigational Site
Toronto, Ontario, Canada, M6M 3Z5
GSK Investigational Site
Mississauga, Ontario, Canada, L5M 4N4
GSK Investigational Site
Burlington, Ontario, Canada, L7N 3V2
GSK Investigational Site
London, Ontario, Canada, N6A 4G5
United Kingdom
GSK Investigational Site
Hull, United Kingdom, HU6 7RX
United Kingdom, Bedfordshire
GSK Investigational Site
Bedford, Bedfordshire, United Kingdom, MK42 9DJ
United Kingdom, Cambridgeshire
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB1 5EF
United Kingdom, Lanarkshire
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G66 3UG
United Kingdom, Warwickshire
GSK Investigational Site
Coventry, Warwickshire, United Kingdom, CV2 2DX
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 101464
Study First Received: July 6, 2004
Last Updated: May 15, 2009
ClinicalTrials.gov Identifier: NCT00086593     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Schizophrenia
atypical antipsychotics
add-on
adjunctive
psychosis

Additional relevant MeSH terms:
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Calcium Channel Blockers
Cardiovascular Agents
Antipsychotic Agents
Pharmacologic Actions
Membrane Transport Modulators
Schizophrenia
Mental Disorders
Therapeutic Uses
Lamotrigine
Central Nervous System Agents
Anticonvulsants
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 27, 2009