Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study
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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 Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia: A Pilot Study |
- Saliva cotinine, Fagerstrom Test for Nicotine Dependence
- 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 |
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| VA San Diego Healthcare System | |
| San Diego, California, United States, 92161 | |
| Principal Investigator: | Jonathan M Meyer, MD | University of California, San Diego |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00167817 History of Changes |
| Other Study ID Numbers: | 030762 |
| Study First Received: | September 10, 2005 |
| Last Updated: | April 18, 2007 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Veterans Medical Research Foundation:
|
Schizophrenia Smoking Metabolic |
Health Glucose Lipids |
Additional relevant MeSH terms:
|
Schizophrenia Smoking Schizophrenia and Disorders with Psychotic Features Mental Disorders Habits Aripiprazole Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 22, 2013