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

July 6, 2004
May 15, 2009
May 2004
 
Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12. [ Time Frame: 12 Weeks ]
Change from baseline in the total score of the Positive and Negative Symptom Scale (PANSS) at Week 12.
Complete list of historical versions of study NCT00086593 on ClinicalTrials.gov Archive Site
- 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 ]
- 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.
 
Study Of An FDA-Approved Drug As Additional Therapy In Patients With Schizophrenia
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

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.

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Schizophrenia
Drug: lamotrigine
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
210
 
 

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   United Kingdom
 
NCT00086593
Study Director, GSK
101464
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
May 2009

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