Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole
Sponsored by

About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Smoking, Metabolic, Health, Glucose, Lipids
Eligibility Criteria
Inclusion Criteria: Schizophrenia, on stable antipsychotic dose for at least one month Ages 18-65 inclusive Overweight (body mass index of 25 kg/m2 or greater) Daily cigarette smoker (by self-report) Exclusion Criteria: Inability to provide informed consent Treatment refractory schizophrenia Current treatment with clozapine Current antipsychotic polypharmacy which may preclude monotherapy with aripiprazole Documented poor compliance with oral antipsychotic medication
Sites / Locations
- VA San Diego Healthcare System
Outcomes
Primary Outcome Measures
Saliva cotinine, Fagerstrom Test for Nicotine Dependence
Secondary Outcome Measures
Weight
Serum glucose and lipids
Rating of symptom severity using the PANSS
Ratings and instrumental measures of motor functioning
Full Information
NCT ID
NCT00167817
First Posted
September 10, 2005
Last Updated
April 18, 2007
Sponsor
Veterans Medical Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00167817
Brief Title
Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study
Official Title
Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Veterans Medical Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Smoking, Metabolic, Health, Glucose, Lipids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aripiprazole
Primary Outcome Measure Information:
Title
Saliva cotinine, Fagerstrom Test for Nicotine Dependence
Secondary Outcome Measure Information:
Title
Weight
Title
Serum glucose and lipids
Title
Rating of symptom severity using the PANSS
Title
Ratings and instrumental measures of motor functioning
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Schizophrenia, on stable antipsychotic dose for at least one month
Ages 18-65 inclusive
Overweight (body mass index of 25 kg/m2 or greater)
Daily cigarette smoker (by self-report)
Exclusion Criteria:
Inability to provide informed consent
Treatment refractory schizophrenia
Current treatment with clozapine
Current antipsychotic polypharmacy which may preclude monotherapy with aripiprazole
Documented poor compliance with oral antipsychotic medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan M Meyer, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study
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