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Clinical Study Of Schizophrenia in Both Men and Women

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00071747
First received: October 30, 2003
Last updated: October 4, 2010
Last verified: October 2010
History of Changes

October 30, 2003
October 4, 2010
August 2003
January 2005   (final data collection date for primary outcome measure)
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 ]
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Complete list of historical versions of study NCT00071747 on ClinicalTrials.gov Archive Site
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 ]
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Clinical Study Of Schizophrenia in Both Men and Women
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.
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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Schizophrenia
Drug: lamotrigine
Other Name: lamotrigine
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
January 2005
January 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00071747
SCA30926
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP