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Clinical Study Of Schizophrenia in Both Men and Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00071747
First Posted: October 31, 2003
Last Update Posted: September 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
October 30, 2003
October 31, 2003
September 1, 2016
August 2003
Not Provided
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 ]
Not Provided
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 ]
Not Provided
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Schizophrenia
Drug: lamotrigine
Not Provided
Goff DC, Keefe R, Citrome L, Davy K, Krystal JH, Large C, Thompson TR, Volavka J, Webster EL. Lamotrigine as add-on therapy in schizophrenia: results of 2 placebo-controlled trials. J Clin Psychopharmacol. 2007 Dec;27(6):582-9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
January 2005
Not Provided

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00071747
SCA30926
No
Not Provided
Plan to Share IPD: Yes
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.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2016

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