Risperidone Augmentation in Patients With Schizophrenia

Completed · Phase 4 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT00289861

Run by

Massachusetts General Hospital

People needed

24

Starts

2003-02-01

Expected to finish

2007-03-01

Last updated by the study team

2013-10-31

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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