Risperidone Augmentation in Patients With Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Oliver Freudenreich, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00289861
First received: February 8, 2006
Last updated: October 29, 2013
Last verified: October 2013
  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
Drug: placebo
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).

Enrollment: 24
Study Start Date: February 2003
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: risperdone Drug: Risperidone
Placebo Comparator: placebo Drug: placebo

  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:

  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
  Contacts and Locations
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, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Oliver Freudenreich, Medical Director, MGH Schizophrenia Program, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00289861     History of Changes
Other Study ID Numbers: 2002-P-000584
Study First Received: February 8, 2006
Last Updated: October 29, 2013
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
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
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on September 22, 2014