Trial Outcomes & Findings for Rapid Antidepressant Effects of Yohimbine in Major Depression (NCT NCT00078715)
NCT ID: NCT00078715
Last Updated: 2019-08-29
Results Overview
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.
COMPLETED
PHASE2
11 participants
Once per day, where the primary comparison involves an average over the full study after controlling for baseline
2019-08-29
Participant Flow
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.
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.
Participant milestones
| Measure |
Yohimbine Then Placebo
Participants are randomized to blindly receive yohimbine for 8 days then placebo for the same.
|
Placebo Then Yohimbine
Participants are randomized to blindly receive placebo for 8 days then yohimbine for the same.
|
|---|---|---|
|
First Intervention
STARTED
|
4
|
2
|
|
First Intervention
COMPLETED
|
4
|
2
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
4
|
2
|
|
Second Intervention
COMPLETED
|
4
|
2
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rapid Antidepressant Effects of Yohimbine in Major Depression
Baseline characteristics by cohort
| Measure |
Overall Study
n=6 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
43.17 years
STANDARD_DEVIATION 11.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Once per day, where the primary comparison involves an average over the full study after controlling for baselineThe 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.
Outcome measures
| Measure |
Placebo
n=6 Participants
Participants are randomized to blindly receive placebo for 8 days.
|
Yohimbine
n=6 Participants
Participants are randomized to blindly receive yohimbine for 8 days.
|
|---|---|---|
|
Hamilton Depression Rating Scale (6 Items)
|
8.776 Units on a scale
Standard Error 1.141
|
9.780 Units on a scale
Standard Error 1.141
|
Adverse Events
Placebo
Yohimbine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=6 participants at risk
|
Yohimbine
n=6 participants at risk
|
|---|---|---|
|
Nervous system disorders
Difficulty sleeping
|
0.00%
0/6
|
33.3%
2/6 • Number of events 2
|
|
Cardiac disorders
Hypertension
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Stomach discomfort
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Taste abnormality
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Increased urination
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint Pain
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Sweating
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
Additional Information
Dr. Carlos A. Zarate, Jr.
Experimental Therapeutics and Pathophysiology Branch, DIRP, NIMH
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place