Status:
COMPLETED
Tetrabenazine for Partial Responders
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Purpose of Study: A) To improve outcome in large population of antipsychotic patients with schizophrenia or schizoaffective who are only partial responders B) To increase understanding of pharmacolog...
Detailed Description
Since the 1950's, antipsychotics have been used as the mainstay treatment to control symptoms of schizophrenia. However, soon after their introduction it became apparent that a substantial number of i...
Eligibility Criteria
Inclusion
- has been on an antipsychotic medication for at least 3 months and achieved the maximum dose vis à vis tolerability/side effects.
- Partial response to antipsychotic medication (CGI \> 4; BPRS \[Anchored, 18-item\] total \> 30; single item score \> 4 on 2 positive symptom items)
- has been on at least 2 previous antipsychotic trials of 4-6 weeks in duration at a dose reaching 400-600 mg chlorpromazine (or equivalent) with no clinical improvement
Exclusion
- age \< 18 or \> 65
- previous documentation of hypersensitivity to tetrabenazine
- SCID criteria for a current depressive episode
- MAOI administration within 2 weeks of tetrabenazine treatment
- concomitant desipramine use
- diagnosis of idiopathic Parkinson's disease and/or levodopa treatment
- current unstable medical illness and current substance abuse
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00362804
Start Date
February 1 2002
End Date
January 1 2006
Last Update
July 6 2012
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5T 1R8