Major depressive disorder is a significant public health problem, disproportionately affecting women. Approximately 70% of patients do not respond or only partially respond to standard SSRI treatment despite adequate dosing. In our open-label pilot data, two-thirds of women with major depressive disorder who were resistant or partially resistant to antidepressants achieved a response to very low-dose, physiologic transdermal testosterone administration;one-third of women treated achieved remission after 8 weeks of therapy, with no hyperandrogenic side effects. We propose a collaborative, randomized, placebo-controlled trial to determine whether larger, multi-center trials are indicated to investigate whether low-dose testosterone is an efficacious and well-tolerated augmentation strategy in women with major depressive disorder and SSRI partial/nonresponse. We propose a collaborative, multidisciplinary study from two academic medical centers in order to increase sample size, accelerate recruitment and increase sample diversity.
Depression is very common, particularly in women, and is disabling. Furthermore, lack of adequate response to commonly prescribed antidepressants is common. The consequences of depressive episodes include problems functioning, low quality of life, and an increased risk of suicide. We propose a collaborative study between two centers to determine, with a randomized, placebo-controlled study, whether the addition of a hormone treatment will improve depression severity in women receiving, but inadequately responding to, SSRI medication prescribed for depression.
|Freeman, Marlene P; Walker, Rosemary; Laughren, Thomas P et al. (2013) Female reproductive life cycle and hormones: methodology to improve clinical trials. J Clin Psychiatry 74:1018-21|