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Clinical Study Of Schizophrenia in Both Men and Women

This study has been completed.

Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00071747
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: lamotrigine
Phase III

MedlinePlus related topics:   Schizophrenia   

Drug Information available for:   Lamotrigine   

U.S. FDA Resources

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment:   176
Study Start Date:   August 2003

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071747

Show 32 study locations  Show 32 Study Locations

Sponsors and Collaborators
GlaxoSmithKline

Investigators
Study Director:     GSK Clinical Trials, MD     GlaxoSmithKline    
  More Information


Responsible Party:   GSK ( Study Director )
Study ID Numbers:   SCA30926
First Received:   October 30, 2003
Last Updated:   October 13, 2008
ClinicalTrials.gov Identifier:   NCT00071747
Health Authority:   United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
lamotrigine  
schizophrenia  

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Lamotrigine
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Anticonvulsants
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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