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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
Enrollment 11
Recruitment Details 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 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.
Arm/Group Title Placebo Then Yohimbine Yohimbine Then Placebo
Hide Arm/Group Description Participants are randomized to blindly receive placebo for 8 days then yohimbine for the same. Participants are randomized to blindly receive yohimbine for 8 days then placebo for the same.
Period Title: First Intervention
Started 2 4
Completed 2 4
Not Completed 0 0
Period Title: Second Intervention
Started 2 4
Completed 2 4
Not Completed 0 0
Arm/Group Title Overall Study
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
<=18 years
0
   0.0%
Between 18 and 65 years
6
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants
43.17  (11.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants
Female
3
  50.0%
Male
3
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants
6
1.Primary Outcome
Title Hamilton Depression Rating Scale (6 Items)
Hide Description The 6 item Hamilton Depression Rating Scale is a measurement of the severity of depression with a range of scores from 0 to 24, where 24 indicates the most severe depression.
Time Frame Once per day, where the primary comparison involves an average over the full study after controlling for baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Yohimbine
Hide Arm/Group Description:
Participants are randomized to blindly receive placebo for 8 days.
Participants are randomized to blindly receive yohimbine for 8 days.
Overall Number of Participants Analyzed 6 6
Mean (Standard Error)
Unit of Measure: Units on a scale
8.776  (1.141) 9.780  (1.141)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Yohimbine
Comments The hypothesis was that yohimbine would provide lower levels of depression than placebo. Initial estimates of sample size assumed a minimum of 25 patients were required to detect differences in depression.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .527
Comments The significance level reflects the direct comparison of drugs after factoring out baseline depression levels.
Method Mixed Models Analysis
Comments A linear mixed model was used with factors for drug, time of evaluation, the drug by time interaction, and a baseline depression covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.004
Confidence Interval (2-Sided) 95%
-4.260 to 2.251
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.141
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 2-4 weeks
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Yohimbine
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Placebo Yohimbine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Yohimbine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Yohimbine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      2/6 (33.33%)    
Cardiac disorders     
Hypertension *  0/6 (0.00%)  0 1/6 (16.67%)  1
Gastrointestinal disorders     
Stomach discomfort *  0/6 (0.00%)  0 1/6 (16.67%)  1
General disorders     
Taste abnormality *  0/6 (0.00%)  0 1/6 (16.67%)  1
Sweating *  0/6 (0.00%)  0 1/6 (16.67%)  1
Musculoskeletal and connective tissue disorders     
Joint Pain *  0/6 (0.00%)  0 1/6 (16.67%)  1
Nervous system disorders     
Difficulty sleeping *  0/6 (0.00%)  0 2/6 (33.33%)  2
Renal and urinary disorders     
Increased urination *  0/6 (0.00%)  0 1/6 (16.67%)  1
*
Indicates events were collected by non-systematic assessment
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
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