search
Back to results

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
Veterans Medical Research Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Smoking, Metabolic, Health, Glucose, Lipids

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 10, 2005
Last Updated
April 18, 2007
Sponsor
Veterans Medical Research Foundation
search

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

We'll reach out to this number within 24 hrs