ClinicalTrials.gov
ClinicalTrials.gov Menu

Rasagiline in the Treatment of Persistent Negative Symptoms of 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: NCT00492336
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : June 19, 2013
Last Update Posted : April 20, 2018
Sponsor:
Collaborator:
Stanley Medical Research Institute
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: rasagiline (Pharmacodynamics)
Drug: Placebo

  Participant Flow

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

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 
Overall Participants Analyzed 
[Units: Participants]
 28   29   57 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      28 100.0%      29 100.0%      57 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 46.3  (12.2)   45.9  (11.1)   46.09  (11.59) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  14.3%      7  24.1%      11  19.3% 
Male      24  85.7%      22  75.9%      46  80.7% 
Region of Enrollment 
[Units: Participants]
     
United States   28   29   57 


  Outcome Measures

1.  Primary:   Change in Negative Symptoms   [ Time Frame: Every 4 weeks over a 12 week period ]

2.  Primary:   Cognitive Testing - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score   [ Time Frame: Beginning of treatment phase (week 0) and end of treatment phase (week 12) ]

3.  Primary:   Cognitive Testing - N-Back Neurocognitive Task   [ Time Frame: Beginning of treatment phase (week 0) and end of treatment phase (week 12) ]

4.  Primary:   Cognitive Testing - Probabilistic Learning Task   [ Time Frame: Beginning of treatment phase (week 0) and end of treatment phase (week 12) ]

5.  Primary:   Cognitive Testing - Delayed Discounting   [ Time Frame: Beginning of treatment phase (week 0) and end of treatment phase (week 12) ]

6.  Secondary:   Extrapyramidal Symptoms   [ Time Frame: Baseline (Week 0) and End of Study (Week 12) ]

7.  Secondary:   Number of Participants With Akathisia   [ Time Frame: Baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks. ]

8.  Secondary:   Change in Persistent Positive Symptoms   [ Time Frame: Every 4 weeks for 12 weeks. ]

9.  Secondary:   Depressive Symptoms   [ Time Frame: Every 4 weeks for 12 weeks. ]

10.  Secondary:   Global Change in Illness Severity   [ Time Frame: Every 4 weeks for 12 weeks. ]

11.  Secondary:   Number of Participants Exhibiting Side Effects   [ Time Frame: Every week for 12 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Robert Buchanan, M.D.
Organization: Maryland Psychiatric Research Center
phone: 410-402-7876
e-mail: rbuchanan@som.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: NCT00492336     History of Changes
Other Study ID Numbers: HP-00043807
H-27877 ( Other Identifier: University of Maryland Baltimore )
First Submitted: June 26, 2007
First Posted: June 27, 2007
Results First Submitted: February 1, 2013
Results First Posted: June 19, 2013
Last Update Posted: April 20, 2018