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

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). Seventy-two menopausal women (mean age: 5...

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Bibliographic Details
Published in:	Menopause (New York, N.Y.) Vol. 13; no. 2; pp. 202 - 211
Main Authors:	Dias, Rodrigo S, Kerr-Corrêa, Florence, Moreno, Ricardo A, Trinca, Luzia A, Pontes, Anagloria, Halbe, Hans W, Gianfaldoni, Arlete, Dalben, Ivete S
Format:	Journal Article
Language:	English
Published:	United States 01-03-2006
Subjects:	Antidepressive Agents, Second-Generation - administration & dosage Antidepressive Agents, Second-Generation - therapeutic use Brazil Cyclohexanols - administration & dosage Cyclohexanols - therapeutic use Depression - blood Depression - drug therapy Depression - etiology Double-Blind Method Drug Therapy, Combination Estrogen Replacement Therapy - adverse effects Estrogen Replacement Therapy - methods Estrogens - administration & dosage Female Gonadal Steroid Hormones - blood Humans Medroxyprogesterone Acetate - administration & dosage Methyltestosterone - administration & dosage Middle Aged Multivariate Analysis Pilot Projects Postmenopause - blood Postmenopause - psychology Quality of Life Research Design Serotonin Uptake Inhibitors - administration & dosage Serotonin Uptake Inhibitors - therapeutic use Surveys and Questionnaires Treatment Outcome Venlafaxine Hydrochloride Brazil
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Summary:	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). 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). 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. 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.
ISSN:	1072-3714
DOI:	10.1097/01.gme.0000198491.34371.9c