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Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine

This study has been completed.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Robert W. Buchanan, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00056498
First received: March 14, 2003
Last updated: April 10, 2015
Last verified: June 2012
Results First Received: March 23, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Placebo
Drug: Risperdal

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Though funding was in place beginning in 2001, recruitment took place from 2003 to 2008. Subjects were recruited from the Maryland Psychiatric Research Center Outpatient Reseach clinic, the Treatment Research Program, and community mental health centers.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
86 Participants signed informed consent. 15 were ineligible or excluded. 71 Participants entered the evaluation phase. Two were withdrawn prior to randomization. Four people withdrew after randomization but prior to starting study medications.

Reporting Groups
  Description
Risperidone Participants assigned to risperidone
Placebo Participants assigned to placebo

Participant Flow:   Overall Study
    Risperidone   Placebo
STARTED   30   35 
COMPLETED   25   28 
NOT COMPLETED   5   7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Risperidone Participants assigned to risperidone
Placebo Participants assigned to placebo
Total Total of all reporting groups

Baseline Measures
   Risperidone   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   35   65 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   30   35   65 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.3  (7.2)   44.1  (9.3)   46.1  (8.6) 
Gender 
[Units: Participants]
     
Female   11   10   21 
Male   19   25   44 
Region of Enrollment 
[Units: Participants]
     
United States   30   35   65 


  Outcome Measures

1.  Primary:   Brief Psychiatric Rating Scale (BPRS)   [ Time Frame: Measured at baseline and every 2 weeks for 16 weeks ]

2.  Secondary:   Neuropsychological Testing   [ Time Frame: Measured at baseline and Week 16 ]
Results not yet reported.   Anticipated Reporting Date:   08/2015   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robert W. Buchanan, MD
Organization: Maryland Psychiatric Research Center
phone: 410-402-7876
e-mail: rwbuchanan@mprc.umaryland.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Robert W. Buchanan, National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00056498     History of Changes
Other Study ID Numbers: R01MH045074 ( US NIH Grant/Contract Award Number )
DSIR 83-ATAP
Study First Received: March 14, 2003
Results First Received: March 23, 2009
Last Updated: April 10, 2015
Health Authority: United States: Federal Government