Following a single-blind 2-week placebo lead-in, patients were randomly assigned to treatment with either a physiologic dose of testosterone cypionate (TC), 100 mg/week, or supraphysiologic dose of 200 mg/week i.m. for 6 weeks
Changes in HAM-D scores
42% decrease in the mean HAM-D scores. However, the majority of the change was due to improvement in the late-onset depression patients. The TC dose did not affect the response.
22 MDD patients with morning serum TT of 350 ng/dL or less who were receiving antidepressant treatment
Range: 30–65 yrs; Mean: (T group) and (placebo group)
12 men received 1% testosterone gel (10 g/day) and 10 received placebo
BDI, HAM-D, CGI-S
Subjects receiving testosterone gel had significantly greater improvement on the HAM-D than subjects receiving placebo. These changes were noted on both the vegetative and affective subscales of the HAM-D. A significant difference was also found on the CGI-S but not on the BDI.
12 hypogonadal men who were receiving antidepressants (on appropriate dose) for a minimum of 6 weeks
Range: 52–80 yrs; Mean:yrs
Placebo or active T gel 1% at a dose of 5 g for 24 weeks
Differences in HAM-D scores
There was a significant improvement in HAM-D at 12 weeks of testosterone treat- ment as compared to baseline. However, there was no statistical difference between placebo and testosterone treatments.
Double-blind RCT followed by an open-label extension phase
33 men with TT levels of ≤280 ng/dL and subthreshold depression (dysthymia or minor depression, according to DSM-IV)
All 50+ yrs old; Mean: yrs (T); yrs (placebo)
Either 7.5 g of testosterone gel (17 men) or placebo gel (16 men) daily for 12 weeks, followed by a 12-week open-label extension phase during which all subjects received 7.5 g of testosterone gel
Differences in HAM-D scores
At the end of the double-blind phase, testosterone-treated men had a greater reduction in HAM-D scores and a higher remission rate of subthreshold depression (52.9% versus 18.8%) than did placebo-treated men. At the end of the extension phase, there were no significant between-group differences in the remission rate of depression between the original testosterone group and the original placebo group (58.8% versus 68.8%, resp.). .
23 men with dysthymic disorder and with low or low-normal T level (i.e, TT < 350 ng/dL)
Mean: yrs
200 mg of testosterone cypionate im or placebo every 10 days for 6 weeks
Difference in HAM-D and CGI-I
HAM-D score decreased significantly more in the T group () than in the placebo group (). Patients in the T group were more likely to remit (53.8% versus 10%) than patients in the placebo group.
100 medically healthy adult men with MDD showing partial response or no response to an adequate SSRI trial during the current episode and a screening TT ≤ 350 ng/dL
Mean: and , respectively for those treated wih T and those in the placebo group
Placebo gel (50 men) or testosterone gel (50 men) at 5 g/day. If the testosterone level at week 1 exceeded the physiologic range (91070 ng/dL), the investigator reduced the dose of gel to 2.5 g/day; if the level was 500 ng/dL or lower, then the investigator issued instructions to raise the dose to 10 g/day
Difference in HAM-D and MADRS
No significant difference in the antidepressant effects of T and placebo gel augmentation
T: testosterone; BT: bioavailable testosterone; FT: free testosterone; DHEA: dehydroepiandrosterone; DHEAS: dehydroepiandrosterone sulphate; SHBG: Sex hormone-binding globulin; BMI: body mass index; HAM-D: Hamilton scale for depression; BDI: Beck depression inventory; CES-D: center for epidemiologic studies depression scale; GDS: geriatric depression scale; POMS: profile of mood states; YMRS: young mania rating scale; CGI-S: clinical global impression scale-severity; CGI-I: clinical global impression scale-improvement; MDD: major depressive disorder; MetS: metabolic syndrome.
