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Trial record 4 of 390 for:    depression NIH

Rapid Antidepressant Effects of Yohimbine in Major Depression

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ClinicalTrials.gov Identifier: NCT00078715
Recruitment Status : Completed
First Posted : March 5, 2004
Results First Posted : August 16, 2012
Last Update Posted : August 20, 2012
Sponsor:
Information provided by (Responsible Party):
Carlos Zarate, M.D., National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Conditions: Depression, Involutional
Major Depresssion
Interventions: Drug: Yohimbine hydrochloride
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
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

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
Overall Study No text entered.

Baseline Measures
   Overall Study 
Overall Participants Analyzed 
[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 ]

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 reported.   Anticipated Reporting Date:   No text entered.  


  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:  
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, 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 by ClinicalTrials.gov Identifier (NCT Number):

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 ( Other Identifier: CNS-IRB, NIH )
First Submitted: March 4, 2004
First Posted: March 5, 2004
Results First Submitted: June 7, 2012
Results First Posted: August 16, 2012
Last Update Posted: August 20, 2012