Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Robert W. Buchanan, M.D., University of Maryland
ClinicalTrials.gov Identifier:
NCT00492336
First received: June 26, 2007
Last updated: June 17, 2013
Last verified: June 2013
Results First Received: February 1, 2013  
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: rasagiline (Pharmacodynamics)
Drug: Placebo

  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
Subjects were recruited between May 2007-October 2011 from mental health clinics throughout the community.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were excluded before assignment to treatment groups if they met any of the exclusion criteria, if they became clinically unstable, or they decided that the demands of the study were too great. 84 participants were enrolled into active participation; 57 started study treatment.

Reporting Groups
  Description
Rasagiline Treatment with Rasagiline
Inactive Pill Treatment with Placebo

Participant Flow:   Overall Study
    Rasagiline     Inactive Pill  
STARTED     28     29  
COMPLETED     26     23  
NOT COMPLETED     2     6  



  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.
No text entered.

Reporting Groups
  Description
Rasagiline Treatment with Rasagiline
Inactive Pill Treatment with Placebo
Total Total of all reporting groups

Baseline Measures
    Rasagiline     Inactive Pill     Total  
Number of Participants  
[units: participants]
  28     29     57  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     28     29     57  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  46.3  ± 12.2     45.9  ± 11.1     46.09  ± 11.59  
Gender  
[units: participants]
     
Female     4     7     11  
Male     24     22     46  
Region of Enrollment  
[units: participants]
     
United States     28     29     57  



  Outcome Measures

1.  Primary:   Scale for the Assessment of Negative Symptoms (SANS)   [ Time Frame: Every 4 weeks over a 12 week period ]

2.  Secondary:   Neuropsychological Tests, Including RBANS, Probabilistic Learning Task, and N-Back Task   [ Time Frame: Beginning of treatment phase (week 0) and end of treatment phase (week 12) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Simpson Angus Scale   [ Time Frame: Every 4 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

4.  Secondary:   Side Effect Checklist and Vital Signs   [ Time Frame: Weekly ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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.  


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


No publications provided


Responsible Party: Robert W. Buchanan, M.D., University of Maryland
ClinicalTrials.gov Identifier: NCT00492336     History of Changes
Other Study ID Numbers: HP-00043807, H-27877
Study First Received: June 26, 2007
Results First Received: February 1, 2013
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration