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Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine

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ClinicalTrials.gov Identifier: NCT00056498
Recruitment Status : Completed
First Posted : March 17, 2003
Results First Posted : July 16, 2012
Last Update Posted : February 15, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Ortho-McNeil Janssen Scientific Affairs, LLC
Information provided by (Responsible Party):
Robert W. Buchanan, University of Maryland

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Placebo
Drug: Risperdal

  Participant Flow

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 Two were withdrawn prior to randomization.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

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.
No text entered.

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]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      30 100.0%      35 100.0%      65 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 48.3  (7.2)   44.1  (9.3)   46.1  (8.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  36.7%      10  28.6%      21  32.3% 
Male      19  63.3%      25  71.4%      44  67.7% 
Region of Enrollment 
[Units: Participants]
     
United States   30   35   65 


  Outcome Measures

1.  Primary:   Positive Symptom Item Scores by Week and Treatment Group   [ Time Frame: Baseline and every two weeks for 16 weeks. ]

2.  Secondary:   Neuropsychological Testing - Overall Composite Z-score   [ Time Frame: Baseline and Week 16 ]

3.  Secondary:   Negative Symptom Total Score by Week and Treatment Group   [ Time Frame: Baseline and every two weeks for 16 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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, University of Maryland
ClinicalTrials.gov Identifier: NCT00056498     History of Changes
Other Study ID Numbers: R01 MH045074 H-21270
R01MH045074 ( U.S. NIH Grant/Contract )
DSIR 83-ATAP
First Submitted: March 14, 2003
First Posted: March 17, 2003
Results First Submitted: March 23, 2009
Results First Posted: July 16, 2012
Last Update Posted: February 15, 2018