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Risperidone Augmentation in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00289861
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : October 31, 2013
Stanley Medical Research Institute
Information provided by (Responsible Party):
Oliver Freudenreich, Massachusetts General Hospital

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 clozapine.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Risperidone Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Risperidone Augmentation in Patients With Schizophrenia Partially Responsive to Clozapine
Study Start Date : February 2003
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone

Arm Intervention/treatment
Active Comparator: risperdone Drug: Risperidone
Placebo Comparator: placebo Drug: placebo

Primary Outcome Measures :
  1. Our primary outcome measure will be change in total score on the Positive and Negative Symptom Scale (PANSS).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Clinical DSM-IV diagnosis of schizophrenia (any subtype) based on chart review and patient interview by research psychiatrist
  2. Ages 18-65
  3. Stable residual psychiatric symptoms defined as PANSS score greater than 60
  4. 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)
  5. On clozapine for at least 6 months and at a stable dose for at least 8 weeks
  6. 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:

  1. Chart diagnosis of dementia or another neurodegenerative disorder, mental retardation, or a pervasive developmental disorder
  2. Suicidal ideation
  3. Substance use disorder (excluding nicotine use) in the past 3 months
  4. Any unstable medical illness
  5. Pregnancy or breast-feeding
  6. Investigational agent in past 30 days
  7. History of adverse reaction to risperidone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00289861

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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Stanley Medical Research Institute
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Principal Investigator: Oliver Freudenreich, M.D. MGH
Principal Investigator: Donald C Goff, M.D. MGH
Publications of Results:
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Responsible Party: Oliver Freudenreich, Medical Director, MGH Schizophrenia Program, Massachusetts General Hospital Identifier: NCT00289861    
Other Study ID Numbers: 2002-P-000584
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: October 31, 2013
Last Verified: October 2013
Keywords provided by Oliver Freudenreich, Massachusetts General Hospital:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents