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.
ClinicalTrials.gov Identifier: NCT00289861
Recruitment Status :
First Posted : February 10, 2006
Last Update Posted : October 31, 2013
Massachusetts General Hospital
Stanley Medical Research Institute
Information provided by (Responsible Party):
Oliver Freudenreich, Massachusetts General Hospital
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.
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.
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Clinical DSM-IV diagnosis of schizophrenia (any subtype) based on chart review and patient interview by research psychiatrist
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.
Chart diagnosis of dementia or another neurodegenerative disorder, mental retardation, or a pervasive developmental disorder
Substance use disorder (excluding nicotine use) in the past 3 months