Status:
UNKNOWN
A Double-Blind, Controlled Study of Aripiprazole in Co-Morbid Schizophrenia and Cocaine Dependence
Lead Sponsor:
Paul Saenger
Conditions:
Schizophrenia
Cocaine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to gather systematic clinical data on whether aripiprazole, a partial dopamine agonist, beneficially affects schizophrenia plus cocaine dependence subjects. Since aripipra...
Eligibility Criteria
Inclusion
- Have a primary DSM-IV diagnosis of Schizophrenia or Schizoaffective disorder
- Have a DSM-IV diagnosis of current cocaine dependence.
- Are capable of reading, comprehending, and signing informed consent.
- Agree to take Aripiprazole or Perphenazine as treatment for SCHZ and CD.
- Agree to stop taking any other antipsychotic medication
- If female and of child bearing potential (WOCBP) agree to use an acceptable form of birth control and have a negative pregnancy test within 2 days prior to starting study medication
Exclusion
- Under 18 years old or over 65 years old.
- Refusal or inability to give informed consent,
- Have a history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities, cerebrovascular disease, or conditions that would predispose to hypotension (dehydration, hypovolemia),
- A history of seizures or conditions that lower the seizure threshold
- Have current suicidal ideation (history of suicide attempt in past 60 days)
- Are actively psychotic which in the opinion of the investigator would preclude proper informed consenting or protocol adherence
- Are receiving or plan to receive an agent metabolized by the Cytochrome P450-3A4 or -2D6 systems, including carbamazepine, ketoconazole, quinidine, fluoxetine, and paroxetine
- WOCBP not on, or do not agree to use an acceptable form of contraception
- Known sensitivity to aripiprazole or perphenazine
- A diagnosis of current or past tardive dyskinesia
- Pending legal charges or a court mandate for drug treatment
- Currently taking concomitant medications that have been shown to reduce cocaine use, such as disulfiram
- Clinically significant liver function abnormalities
- Currently receiving depot neuroleptics
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00737256
Start Date
August 1 2008
End Date
May 1 2014
Last Update
September 7 2012
Active Locations (1)
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1
Veteran's Affairs Medical Center
Denver, Colorado, United States, 80220