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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:
ClinicalTrials.gov Identifier:
NCT00167817
First Posted: September 14, 2005
Last Update Posted: April 19, 2007
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:
Veterans Medical Research Foundation
  Purpose
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.

Condition Intervention Phase
Schizophrenia Drug: Aripiprazole Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Veterans Medical Research Foundation:

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

Estimated Enrollment: 15
Study Start Date: July 2003
Study Completion Date: September 2005
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167817


Locations
United States, California
VA San Diego Healthcare System
San Diego, California, United States, 92161
Sponsors and Collaborators
Veterans Medical Research Foundation
Investigators
Principal Investigator: Jonathan M Meyer, MD University of California, San Diego
  More Information

ClinicalTrials.gov Identifier: NCT00167817     History of Changes
Other Study ID Numbers: 030762
First Submitted: September 10, 2005
First Posted: September 14, 2005
Last Update Posted: April 19, 2007
Last Verified: April 2007

Keywords provided by Veterans Medical Research Foundation:
Schizophrenia
Smoking
Metabolic
Health
Glucose
Lipids

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs