Trial Outcomes & Findings for Testosterone Antidepressant Augmentation in Women (NCT NCT01783574)
NCT ID: NCT01783574
Last Updated: 2018-06-06
Results Overview
Montgomery-Asberg Depression Rating Score (MADRS) Score: This scale measures depression symptom severity. Higher scores indicate more severe depression symptom severity. The score range is 0-60 units on a scale.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
Week 8
Results posted on
2018-06-06
Participant Flow
Participant milestones
| Measure |
Testosterone
Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.
Testosterone
|
Placebo
Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
|
Overall Study
COMPLETED
|
46
|
41
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testosterone Antidepressant Augmentation in Women
Baseline characteristics by cohort
| Measure |
Testosterone
n=51 Participants
Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.
Testosterone
|
Placebo
n=50 Participants
Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.
Placebo
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
STANDARD_DEVIATION 14 • n=5 Participants
|
48 years
STANDARD_DEVIATION 14 • n=7 Participants
|
47 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
51 participants
n=5 Participants
|
50 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
BMI
|
28.2 kg/m2
STANDARD_DEVIATION 7.6 • n=5 Participants
|
30.3 kg/m2
STANDARD_DEVIATION 7.9 • n=7 Participants
|
29.2 kg/m2
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Mean MADRS Score
|
26.8 units on a scale
STANDARD_DEVIATION 6.3 • n=5 Participants
|
26.3 units on a scale
STANDARD_DEVIATION 5.4 • n=7 Participants
|
26.6 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Postmenopausal
|
20 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Brief Fatigue Inventory
|
6.2 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
5.6 units on a scale
STANDARD_DEVIATION 2.0 • n=7 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Derogatis Inventory of Sexual Function
|
32.8 units on a scale
STANDARD_DEVIATION 27.3 • n=5 Participants
|
38.7 units on a scale
STANDARD_DEVIATION 30.1 • n=7 Participants
|
35.7 units on a scale
STANDARD_DEVIATION 28.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 8Montgomery-Asberg Depression Rating Score (MADRS) Score: This scale measures depression symptom severity. Higher scores indicate more severe depression symptom severity. The score range is 0-60 units on a scale.
Outcome measures
| Measure |
Testosterone
n=51 Participants
Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.
Testosterone
|
Placebo
n=50 Participants
Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.
Placebo
|
|---|---|---|
|
Depressive Symptom Severity
|
15.3 units on a scale
Standard Error 1.4
|
14.1 units on a scale
Standard Error 1.4
|
SECONDARY outcome
Timeframe: Week 8Brief Fatigue Inventory: This inventory measures fatigue severity. Higher scores indicate more severe fatigue. The range is 0-10 units on a scale.
Outcome measures
| Measure |
Testosterone
n=51 Participants
Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.
Testosterone
|
Placebo
n=50 Participants
Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.
Placebo
|
|---|---|---|
|
Fatigue
|
4.0 units on a scale
Standard Error 0.3
|
3.7 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: Week 8Derogatis Interview of Sexual Function (Total Score): This scale measures sexual function. Lower scores indicate worse sexual function. The score range for this questionnaire is 0-160.
Outcome measures
| Measure |
Testosterone
n=51 Participants
Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.
Testosterone
|
Placebo
n=50 Participants
Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.
Placebo
|
|---|---|---|
|
Sexual Dysfunction
|
45.1 units on a scale
Standard Error 4.7
|
47.5 units on a scale
Standard Error 5.4
|
Adverse Events
Testosterone
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Testosterone
n=51 participants at risk
Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.
Testosterone
|
Placebo
n=50 participants at risk
Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.
Placebo
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Acne
|
13.7%
7/51 • 8 weeks
Definition of serious adverse event is as defined on the clinicaltrials.gov website.
|
6.0%
3/50 • 8 weeks
Definition of serious adverse event is as defined on the clinicaltrials.gov website.
|
|
Reproductive system and breast disorders
Hot flashes
|
3.9%
2/51 • 8 weeks
Definition of serious adverse event is as defined on the clinicaltrials.gov website.
|
12.0%
6/50 • 8 weeks
Definition of serious adverse event is as defined on the clinicaltrials.gov website.
|
|
General disorders
Headache
|
11.8%
6/51 • 8 weeks
Definition of serious adverse event is as defined on the clinicaltrials.gov website.
|
10.0%
5/50 • 8 weeks
Definition of serious adverse event is as defined on the clinicaltrials.gov website.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place