Risperidone Augmentation
This study has been completed.
Sponsor:
Massachusetts General Hospital
Collaborator:
Stanley Medical Research Institute
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00289861
First received: February 8, 2006
Last updated: April 23, 2007
Last verified: April 2007
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Purpose
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 clozapine.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Risperidone |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Risperidone Augmentation in Patients With Schizophrenia Partially Responsive to Clozapine |
Resource links provided by NLM:
Further study details as provided by Massachusetts General Hospital:
Primary Outcome Measures:
- Our primary outcome measure will be change in total score on the Positive and Negative Symptom Scale (PANSS).
Secondary Outcome Measures:
- Tolerability as measured by:
- SAFTEE-SI
- SAFTEE-GI
- Out of range laboratory values
- Vital signs
- AIMS
- BAS
- SAS
- Change in prolactin levels over an 8 week period
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2003 |
| Study Completion Date: | October 2006 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289861
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
Stanley Medical Research Institute
Investigators
| Principal Investigator: | Oliver Freudenreich, M.D. | MGH |
| Principal Investigator: | Donald C Goff, M.D. | MGH |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00289861 History of Changes |
| Other Study ID Numbers: | 2002-P-000584 |
| Study First Received: | February 8, 2006 |
| Last Updated: | April 23, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Massachusetts General Hospital:
|
Schizophrenia risperidone prolactin clozapine |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Clozapine Risperidone Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs GABA Antagonists GABA Agents Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 19, 2013