Trial Outcomes & Findings for AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment (NCT NCT00304746)
NCT ID: NCT00304746
Last Updated: 2010-11-24
Results Overview
The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression).
COMPLETED
PHASE4
100 participants
9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment)
2010-11-24
Participant Flow
The study was conducted at two sites - McLean Hospital in Belmont Massachusetts, USA and the Chaim Sheba Medical Center in Tel Hashomer, Israel. Using advertisements at each site, we recruited men age 30-65 with major depressive disorder incompletely responsive to a serotonergic antidepressant, and showing a total testosterone level ≤ 350 ng/dL.
At baseline, participants began a 1-week, single-blind placebo lead-in of one packet of placebo gel daily. Men exhibiting ≥ 50% improvement on either the Hamilton Depression Rating Scale (HAM-D) or Montgomery-Asberg Depression Rating Scale (MADRS) after placebo lead-in were withdrawn; all others were randomized to study medication.
Participant milestones
| Measure |
Testosterone Gel
AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
|
Placebo Gel
Placebo gel identical in appearance to the testosterone gel
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment
Baseline characteristics by cohort
| Measure |
Testosterone Gel
n=50 Participants
AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
|
Placebo Gel
n=50 Participants
Placebo gel identical in appearance to the testosterone gel
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
50.6 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
49.9 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
50.3 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
24 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
21 participants
n=5 Participants
|
26 participants
n=7 Participants
|
47 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment)Population: All of the 100 randomized participants are included in the Last Observation Carried Forward (LOCF) analysis presented here online, which provides the mean and SD of this outcome measure for each study arm. Full details of all analyses are provided in the published paper presenting the results of the study.
The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression).
Outcome measures
| Measure |
Testosterone Gel
n=50 Participants
AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
|
Placebo Gel
n=50 Participants
Placebo gel identical in appearance to the testosterone gel
|
|---|---|---|
|
21-item Hamilton Depression Rating Scale Score (HAM-D)
|
13.5 units on a scale
Standard Deviation 7.1
|
15.6 units on a scale
Standard Deviation 6.2
|
SECONDARY outcome
Timeframe: 9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment)Population: All of the 100 randomized participants are included in the Last Observation Carried Forward (LOCF) analysis presented here online, which provides the mean and SD of this outcome measure for each study arm. Full details of all analyses are provided in the published paper presenting the results of the study.
The Montgomery Asberg Depression Rating Scale (MADRS) is a clinician-assessed scale that rates depressive symptoms on a scale from 0 (no depressive symptoms) to 60 (maximal depressive symptoms).
Outcome measures
| Measure |
Testosterone Gel
n=50 Participants
AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
|
Placebo Gel
n=50 Participants
Placebo gel identical in appearance to the testosterone gel
|
|---|---|---|
|
Montgomery Asberg Depression Rating Scale (MADRS)
|
17.9 units on a scale
Standard Deviation 9.0
|
19.9 units on a scale
Standard Deviation 8.4
|
Adverse Events
Testosterone Gel
Placebo Gel
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Testosterone Gel
n=50 participants at risk
AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
|
Placebo Gel
n=50 participants at risk
Placebo gel identical in appearance to the testosterone gel
|
|---|---|---|
|
Nervous system disorders
headache
|
6.0%
3/50 • Number of events 3 • Adverse events were assessed at all study visits throughout the eight-week blinded phase of the study.
|
0.00%
0/50 • Adverse events were assessed at all study visits throughout the eight-week blinded phase of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place