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Rapid Antidepressant Effects of Yohimbine in 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:
NCT00078715
First received: March 4, 2004
Last updated: August 16, 2012
Last verified: August 2012
History of Changes
Results First Received: June 7, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Conditions: Depression, Involutional
Major Depresssion
Interventions: Drug: Yohimbine hydrochloride
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with major depression were recruited to participate in the study at the Clinical Center on the main campus of the National Institutes of Health in Bethesda, Maryland. Recruiting began in 2004.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
11 participants were run through a sleep deprivation procedure and 6 of those had a significant improvement in depression. These 6 sleep deprivation responders were randomized in the crossover yohimbine study.

Reporting Groups
  Description
Placebo Then Yohimbine Participants are randomized to blindly receive placebo for 8 days then yohimbine for the same.
Yohimbine Then Placebo Participants are randomized to blindly receive yohimbine for 8 days then placebo for the same.

Participant Flow for 2 periods

 Period 1:   First Intervention
    Placebo Then Yohimbine     Yohimbine Then Placebo  
STARTED     2     4  
COMPLETED     2     4  
NOT COMPLETED     0     0  

Period 2:   Second Intervention
    Placebo Then Yohimbine     Yohimbine Then Placebo  
STARTED     2     4  
COMPLETED     2     4  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Overall Study No text entered.

Baseline Measures
    Overall Study  
Number of Participants  
[units: participants]
 		  6  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     6  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation 		  43.17  ± 11.85  
Gender  
[units: participants]
 		 
Female     3  
Male     3  
Region of Enrollment  
[units: participants]
 		 
United States     6  



  Outcome Measures

1.  Primary:   Hamilton Depression Rating Scale (6 Items)   [ Time Frame: Once per day, where the primary comparison involves an average over the full study after controlling for baseline ]
  Show Outcome Measure 1

2.  Secondary:   To Determine Whether Measures Previously Demonstrated to be Predictive of Response to Sleep Deprivation & Noradrenergically Mediated Will be Assoc With Response to Yohimbine When Administered During REM Sleep.   [ Time Frame: 2-4 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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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.


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. Carlos A. Zarate, Jr.
Organization: Experimental Therapeutics and Pathophysiology Branch, DIRP, NIMH
phone: 301-451-0861
e-mail: zaratec@mail.nih.gov


Publications:

Publications automatically indexed to this study:


Responsible Party: Carlos Zarate, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00078715     History of Changes
Other Study ID Numbers: 040091, 04-M-0091
Study First Received: March 4, 2004
Results First Received: June 7, 2012
Last Updated: August 16, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration