Efficacy of hormone therapy with and without methyltestosterone augmentation...

This is from the journal Menopause.  The
link goes to the abstract; a subcription is required for full access.
 It is a pilot study with results that are not robust enough
to use in routine clinical decision-making, but it does indicate a
possible benefit to supplementation of venlafaxine (Effexor) with HRT
in depressed postmenopausal women.  

href="http://www.menopausejournal.com/pt/re/menopause/abstract.00042192-200613020-00011.htm;jsessionid=Fg9ZyB1TT5h1lKGn52MG1XLKMd3v4rT7knF02TDQV2jRY25S6tvX%211096339265%21-949856144%218091%21-1">Menopause

2006 Mar-Apr;13(2):202-11.

Efficacy of hormone therapy with and without methyltestosterone
augmentation of venlafaxine in the treatment of postmenopausal
depression: a double-blind controlled pilot study.

Dias RS, Kerr-Correa F, Moreno RA, Trinca LA, Pontes A, Halbe HW,
Gianfaldoni A, Dalben IS.

 

Department of Neurology and Psychiatry, Botucatu Medical School, Sao
Paulo, Brazil. rodrigosildias@uol.com.br



OBJECTIVE: This study evaluated the augmentation of venlafaxine with
hormone therapy in the treatment of postmenopausal depression. The
hormones evaluated were estrogen (0.625 mg) in combination with
medroxyprogesterone acetate (2.5 mg) and methyltestosterone (2.5 mg).
DESIGN: Seventy-two menopausal women (mean age: 53.6 +/- 4.27 years)
diagnosed with depression (Montgomery-Asberg Depression Rating Scale
[MADRS] scores > or = 20) were treated with venlafaxine and one
of
the following hormone therapy combinations, in a double-blind regimen:
estrogen + medroxyprogesterone + methyltestosterone (group 1, n = 20);
estrogen + medroxyprogesterone acetate (group 2, n = 20);
methyltestosterone only (group 3, n = 16); and no hormone therapy
(group 4, n = 16). Study duration was 24 weeks. Primary efficacy
outcome was remission according to the MADRS, whereas secondary
efficacy measures included the Clinical Global Impression (CGI),
Blatt-Kupperman Index, and Women's Health Questionnaire (WHQ). RESULTS:
Forty-eight patients completed the study. All groups showed significant
improvement from baseline. Group 3 demonstrated significant improvement
on the MADRS compared with placebo (group 4) at weeks 20 (P = 0.048)
and 24 (P = 0.030); effect size 8.04 (0.83; 15.26) (P = 0.029), but
also had the highest dropout rate. Groups 1 and 3 had significant CGI
improvement rates compared with placebo: 42.23% (P = 0.012) and 44.45%
(P = 0.08), respectively. There were no differences in the WHQ or BKI
scores among the groups. CONCLUSIONS: Methyltestosterone 2.5 mg had the
highest effect size compared with placebo, but the high dropout rate
prevented its efficacy from being determined. Estrogen plus
medroxyprogesterone, combined with methyltestosterone or otherwise,
demonstrated a trend toward increased efficacy of venlafaxine. Further
larger-scale clinical trials are needed to elucidate the findings of
this pilot study.

Note that the biggest effect was seen in the methytestosterone, but the
adverse effects apparently led to a lot of treatment dropouts.
 That meant that the data were not strong enough to be
conclusive of anything.  



Even so, the pilot study is not useless; it can give the researchers an
idea of how best to design a more definitive study.