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Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study

This study has been completed.
Sponsor:
Information provided by:
Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00167817
First received: September 10, 2005
Last updated: April 18, 2007
Last verified: April 2007

September 10, 2005
April 18, 2007
July 2003
Not Provided
Saliva cotinine, Fagerstrom Test for Nicotine Dependence
Same as current
Complete list of historical versions of study NCT00167817 on ClinicalTrials.gov Archive Site
  • Weight
  • Serum glucose and lipids
  • Rating of symptom severity using the PANSS
  • Ratings and instrumental measures of motor functioning
Same as current
Not Provided
Not Provided
 
Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study
Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study

Patients with schizophrenia are much more likely to be engaged in smoking and other addictive behaviors, possibly related to biochemical abnormalities in the reward center of the brain. The primary purpose of the present study is to investigate whether switching patients with schizophrenia to a new atypical antipsychotic, aripiprazole, a drug with a novel mechanism of action, will have an impact on smoking behavior.

This is an 8 week open label trial being conducted in stable adult outpatients with schizophrenia who are smokers. The primary intervention is a switch in the subject's antipsychotic to aripiprazole, flexibly dosed between 15-30 mg/day. The outcome measures include a rating of smoking behavior using the Fagerstrom Test for Nicotine Dependence, and saliva cotinine obtained at baseline and endpoint. Secondary measures include weight, serum glucose and lipids, rating of symptom severity using the PANSS, and both ratings and instrumental measures of motor functioning. We anticipate enrolling up to 25 subjects to obtain the needed 15 completers at the week 8 endpoint.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
Drug: Aripiprazole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
September 2005
Not Provided

Inclusion Criteria:

  1. Schizophrenia, on stable antipsychotic dose for at least one month
  2. Ages 18-65 inclusive
  3. Overweight (body mass index of 25 kg/m2 or greater)
  4. Daily cigarette smoker (by self-report)

Exclusion Criteria:

  1. Inability to provide informed consent
  2. Treatment refractory schizophrenia
  3. Current treatment with clozapine
  4. Current antipsychotic polypharmacy which may preclude monotherapy with aripiprazole
  5. Documented poor compliance with oral antipsychotic medication
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00167817
030762
No
Not Provided
Veterans Medical Research Foundation
Not Provided
Principal Investigator: Jonathan M Meyer, MD University of California, San Diego
Veterans Medical Research Foundation
April 2007

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