Cognitive Enhancement in Bipolar Disorder

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Ray, Susan, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00597896
First received: January 8, 2008
Last updated: June 10, 2015
Last verified: June 2015
Results First Received: January 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bipolar Disorder
Intervention: Drug: pramipexole

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Active Pramipexole 0.125 mg BID-0.75 mg BID pramipexole
Placebo Pramipexole 0.125 mg BID-0.75 mg BID - matching placebo

Participant Flow:   Overall Study
    Active Pramipexole     Placebo Pramipexole  
STARTED     24     26  
COMPLETED     21     24  
NOT COMPLETED     3     2  



  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
Active Pramipexole 0.125 mg BID-0.75 mg BID - pramipexole
Placebo Pramipexole 0.125 mg BID-0.75 mg BID - matching placebo
Total Total of all reporting groups

Baseline Measures
    Active Pramipexole     Placebo Pramipexole     Total  
Number of Participants  
[units: participants]
  21     24     45  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     21     24     45  
>=65 years     0     0     0  
Age  
[units: years]
Mean (Standard Deviation)
  43.81  (9.4)     44.42  (12.2)     44.14  (10.9)  
Gender  
[units: participants]
     
Female     14     10     24  
Male     7     14     21  
Region of Enrollment  
[units: participants]
     
United States     21     24     45  



  Outcome Measures
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1.  Primary:   Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Forward)   [ Time Frame: Change from Baseline to Week 8 ]

2.  Primary:   Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Span Subtest (Digits Backward)   [ Time Frame: Change from Baseline to Week 8 ]

3.  Primary:   Change From Baseline to Week 8 in Weschler Adult Intelligence Scale-Third Edition (WAIS-III) Digit Symbol Coding Test   [ Time Frame: Change from Baseline to Week 8 ]

4.  Primary:   Change From Baseline to Week 8 in Stroop Color-Word Test   [ Time Frame: Change from Baseline to Week 8 ]

5.  Primary:   Change From Baseline to Week 8 in Trail Making Test Part A   [ Time Frame: Change from Baseline to Week 8 ]

6.  Primary:   Change From Baseline to Week 8 in Trail Making Test Part B   [ Time Frame: Change from Baseline to Week 8 ]

7.  Primary:   Change From Baseline to Week 8 in d2 Test of Attention   [ Time Frame: Change from Baseline to Week 8 ]

8.  Primary:   Change From Baseline to Week 8 in Hopkins Verbal Learning Test   [ Time Frame: Change from Baseline to Week 8 ]

9.  Primary:   Change From Baseline to Week 8 in Controlled Oral Word Association Test (COWAT) Letter Fluency   [ Time Frame: Change from Baseline to Week 8 ]

10.  Secondary:   Double-blind: Change From Baseline in Hamilton Rating Scale for Depression (HAM-D-21) Total Score at Endpoint   [ Time Frame: Change from Baseline to Week 8 ]

11.  Secondary:   Double-blind: Change From Baseline in Clinician-Administered Rating Scale for Mania (CARS-M)Total Score at Endpoint   [ Time Frame: Change from Baseline to Week 8 ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Katherine E. Burdick, PhD
Organization: Mount Sinai School of Medicine
e-mail: katherine.burdick@mssm.edu


Publications of Results:

Responsible Party: Ray, Susan, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00597896     History of Changes
Other Study ID Numbers: 05-069, 05T-670
Study First Received: January 8, 2008
Results First Received: January 4, 2013
Last Updated: June 10, 2015
Health Authority: United States: Institutional Review Board