Risperidone Augmentation in Patients With Schizophrenia
1 other identifier
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 schizophrenia
Started Feb 2003
Typical duration for phase_4 schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 8, 2006
CompletedFirst Posted
Study publicly available on registry
February 10, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedOctober 31, 2013
October 1, 2013
4.1 years
February 8, 2006
October 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Our primary outcome measure will be change in total score on the Positive and Negative Symptom Scale (PANSS).
Study Arms (2)
risperdone
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Stanley Medical Research Institutecollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (1)
Freudenreich O, Henderson DC, Walsh JP, Culhane MA, Goff DC. Risperidone augmentation for schizophrenia partially responsive to clozapine: a double-blind, placebo-controlled trial. Schizophr Res. 2007 May;92(1-3):90-4. doi: 10.1016/j.schres.2006.12.030. Epub 2007 Feb 23.
PMID: 17321111RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oliver Freudenreich, M.D.
MGH
- PRINCIPAL INVESTIGATOR
Donald C Goff, M.D.
MGH
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Director, MGH Schizophrenia Program
Study Record Dates
First Submitted
February 8, 2006
First Posted
February 10, 2006
Study Start
February 1, 2003
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
October 31, 2013
Record last verified: 2013-10