Overview

Risperidone Augmentation in Patients With Schizophrenia

Status:
Completed

Trial end date:
2007-03-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Massachusetts General Hospital

Collaborator:

Stanley Medical Research Institute

Treatments:

Clozapine
Risperidone

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