Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167817
Status:
COMPLETED
Last Update Posted:
2007-04-19
First Post:
2005-09-10
Brief Title:
Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia A Pilot Study
Sponsor:
Veterans Medical Research Foundation
Organization:
Veterans Medical Research Foundation
Study Overview
Official Title:
Effect of Switch to Aripiprazole on Health and Smoking Parameters in Patients With Schizophrenia A Pilot Study
Status:
COMPLETED
Status Verified Date:
2007-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 subjects antipsychotic to aripiprazole flexibly dosed between 15-30 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None