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Imaging the Nucleus Accumbens in Major Depressed Patients 'Treated With Pramipexole

This study has been terminated.
(Lack of funding prevented further recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01066897
First Posted: February 10, 2010
Last Update Posted: May 16, 2017
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.
Collaborator:
National Alliance for Research on Schizophrenia and Depression
Information provided by (Responsible Party):
Jennifer Keller, Stanford University
Results First Submitted: October 11, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Depression
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pramipexole

Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.

Pramipexole: Patients will received increasing dose of pramipexole

Healthy Controls Non depressed, non treatment comparison group

Participant Flow:   Overall Study
    Pramipexole   Healthy Controls
STARTED   7   9 
COMPLETED   5   9 
NOT COMPLETED   2   0 
Withdrawal by Subject                1                0 
stopped study after developing the flu.                1                0 



  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
Pramipexole

Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.

Pramipexole: Patients will received increasing dose of pramipexole

Healthy Controls Non depressed, non treatment comparison group from baseline
Total Total of all reporting groups

Baseline Measures
   Pramipexole   Healthy Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   9   16 
Age 
[Units: Years]
Mean (Standard Deviation)
 44.00  (14.12)   34.78  (14.0)   38.81  (14.41) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7 100.0%      3  33.3%      10  62.5% 
Male      0   0.0%      6  66.7%      6  37.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      1  11.1%      1   6.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      3  33.3%      3  18.8% 
White      7 100.0%      5  55.6%      12  75.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   7   9   16 


  Outcome Measures
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1.  Primary:   Number of Participants Who Discontinued Study Due to Side-effects of the Medication   [ Time Frame: throughout the 8 weeks ]

2.  Primary:   % Change in Hamilton Depression Rating Scale From Baseline to week8   [ Time Frame: Baseline and weeks 8 ]

3.  Primary:   Change in Mesolimbic Reward System Activity From Pre to Post Treatment (8 Weeks)   [ Time Frame: baseline and Week 8 ]

4.  Secondary:   Mesolimibic Reward Activity Baseline Differences in Depression vs Healthy Controls   [ Time Frame: Baseline ]


  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
The sample size is really too small for statistical analyses. Lack of funding prevented further recruitment.


  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: Dr. Jennifer Keller
Organization: Stanford University
phone: 650-724-0070
e-mail: jkeller@stanford.edu



Responsible Party: Jennifer Keller, Stanford University
ClinicalTrials.gov Identifier: NCT01066897     History of Changes
Other Study ID Numbers: SU-02042010-4902
17847
First Submitted: February 9, 2010
First Posted: February 10, 2010
Results First Submitted: October 11, 2016
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017