Status:
COMPLETED
Risperidone Augmentation in Patients With Schizophrenia
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
We propose a double-blind, placebo-controlled trial to study the effectiveness and tolerability of adding risperidone to stable yet only partially remitted patients with schizophrenia maintained on cl...
Detailed Description
Specific Aims - We propose a double-blind, placebo-controlled trial to study the effectiveness and tolerability of adding risperidone to stable yet only partially remitted patients with schizophrenia ...
Eligibility Criteria
Inclusion
- Clinical DSM-IV diagnosis of schizophrenia (any subtype) based on chart review and patient interview by research psychiatrist
- Ages 18-65
- Stable residual psychiatric symptoms defined as PANSS score greater than 60
- On clozapine monotherapy with plasma level of at least 200 ng/mL (unless the patient refuses a dose adjustment or does not tolerate a higher dose)
- On clozapine for at least 6 months and at a stable dose for at least 8 weeks
- Competent to provide informed consent. If the subject has a guardian, assent must be given by the subject and consent must be given by the guardian.
Exclusion
- Chart diagnosis of dementia or another neurodegenerative disorder, mental retardation, or a pervasive developmental disorder
- Suicidal ideation
- Substance use disorder (excluding nicotine use) in the past 3 months
- Any unstable medical illness
- Pregnancy or breast-feeding
- Investigational agent in past 30 days
- History of adverse reaction to risperidone
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00289861
Start Date
February 1 2003
End Date
March 1 2007
Last Update
October 31 2013
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114