Risperidone Augmentation

This study has been completed.

Sponsors and Collaborators:	Massachusetts General Hospital Stanley Medical Research Institute
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00289861

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 IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Clozapine Prolactin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Risperidone Augmentation in Patients With Schizophrenia Partially Responsive to Clozapine

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

Study ID Numbers:	2002-P-000584
Study First Received:	February 8, 2006
Last Updated:	April 23, 2007
ClinicalTrials.gov Identifier:	NCT00289861
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

Schizophrenia
risperidone
prolactin
clozapine

Study placed in the following topic categories:

Schizophrenia
Dopamine
Mental Disorders
Clozapine

Risperidone
Psychotic Disorders
Serotonin
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Dopamine Antagonists

Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009