Lexapro and Pramipexole and to Treat Major Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlos Zarate, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00086307
First received: June 29, 2004
Last updated: January 11, 2013
Last verified: January 2013
Results First Received: June 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Major Depression
Interventions: Drug: Pramipexole
Drug: Escitalopram

  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
Pramipexole Patients receive pramipexole and placebo.
Escitalopram Patients receive escitalopram and placebo.
Escitalopram and Pramipexole Patients receive escitalopram and pramipexole.

Participant Flow:   Overall Study
    Pramipexole     Escitalopram     Escitalopram and Pramipexole  
STARTED     13     13     13  
COMPLETED     11     12     5  
NOT COMPLETED     2     1     8  
Lack of Efficacy                 1                 1                 2  
Shortness of breath and muscle spasms                 1                 0                 0  
Nausea and headaches                 0                 0                 1  
Constipation and sleepiness                 0                 0                 1  
Suicidal ideation                 0                 0                 1  
Fatigue and difficulty falling asleep                 0                 0                 1  
Withdrawal by Subject                 0                 0                 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
Pramipexole Patients receive pramipexole and placebo.
Escitalopram Patients receive escitalopram and placebo.
Escitalopram and Pramipexole Patients receive escitalopram and pramipexole.
Total Total of all reporting groups

Baseline Measures
    Pramipexole     Escitalopram     Escitalopram and Pramipexole     Total  
Number of Participants  
[units: participants]
  13     13     13     39  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     13     13     13     39  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  44.8  ± 10.1     45.6  ± 13.6     45.3  ± 12.7     45.3  ± 11.9  
Gender  
[units: participants]
       
Female     7     9     11     27  
Male     6     4     2     12  
Region of Enrollment  
[units: participants]
       
United States     13     13     13     39  



  Outcome Measures

1.  Primary:   Montgomery Asberg Depression Rating Scale (MADRS)   [ Time Frame: Weekly ]


  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:  
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. Carlos A. Zarate
Organization: NIMH
phone: 301-451-0861
e-mail: zaratec@mail.nih.gov


Publications:

Responsible Party: Carlos Zarate, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00086307     History of Changes
Other Study ID Numbers: 040227, 04-M-0227
Study First Received: June 29, 2004
Results First Received: June 7, 2012
Last Updated: January 11, 2013
Health Authority: United States: Federal Government