1. Efficacy of hormone therapy with and without methyltestosterone augmentation of venlafaxine in the treatment of postmenopausal depression: a double-blind controlled pilot study
- Author
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Luzia A. Trinca, Hans Wolfgang Halbe, Anaglória Pontes, Arlete Gianfaldoni, Rodrigo da Silva Dias, Florence Kerr-Corrêa, Ricardo Alberto Moreno, and Ivete Dalben
- Subjects
medicine.medical_specialty ,medicine.drug_class ,medicine.medical_treatment ,Medroxyprogesterone ,Pilot Projects ,Medroxyprogesterone Acetate ,Placebo ,Gastroenterology ,Double-Blind Method ,Methyltestosterone ,Surveys and Questionnaires ,Internal medicine ,medicine ,Humans ,Medroxyprogesterone acetate ,Gonadal Steroid Hormones ,Depression ,business.industry ,Estrogen Replacement Therapy ,Venlafaxine Hydrochloride ,Obstetrics and Gynecology ,Estrogens ,Middle Aged ,Cyclohexanols ,medicine.disease ,Postmenopause ,Menopause ,Treatment Outcome ,Endocrinology ,Research Design ,Estrogen ,Multivariate Analysis ,Quality of Life ,Clinical Global Impression ,Antidepressive Agents, Second-Generation ,Drug Therapy, Combination ,Female ,Hormone therapy ,business ,Brazil ,Selective Serotonin Reuptake Inhibitors ,medicine.drug - Abstract
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.
- Published
- 2006