Status:
COMPLETED
Determining the Effects of Risperdal Consta in Patients With Psychotic Disorders and Incomplete Adherence
Lead Sponsor:
Duke University
Collaborating Sponsors:
Janssen, LP
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
As many as 75 percent of patients with schizophrenia have difficulty taking their oral medication on a regular basis. This may lead to worsening of symptoms. Clinicians commonly respond to these probl...
Eligibility Criteria
Inclusion
- Eligible patients will be male or female
- Between 18-65 years of age and will meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
- The subject must have, in their physicians opinion, an unstable course and must have been treated with an oral antipsychotic.
Exclusion
- Pregnant and breast feeding females will be excluded.
- Because fluoxetine is known to change the plasma level of CONSTA, subjects taking fluoxetine within two weeks of starting the study will be excluded.
- Patients who are known to have a hypersensitivity to oral Risperdal will be excluded.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2006
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00215579
Start Date
April 1 2004
End Date
April 1 2006
Last Update
September 22 2014
Active Locations (1)
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1
John Umstead Hospital
Butner, North Carolina, United States, 27509