Augmentation of Treatment-Resistant Depression With An Analog of the Neuroactive Steroid Allopregnanolone

Summary

Major depressive disorder (MDD) is highly prevalent and nearly 70% of individuals with MDD do not respond to standard antidepressant therapies despite adequate dosing. An effective and well-tolerated antidepressant augmentation therapy would have important clinical and public health implications. Neuroactive steroid hormones are known to directly activate neurotransmitter receptors in the brain, and thus are potential candidates for augmentation therapies to enhance the effect of traditional antidepressants. The investigators hypothesize that administration of an allopregnanolone analog in women with treatment-resistant depression will improve depressive symptoms.

Timeline

Start

2016-11

Primary completion

2018-01-12

Completion

2018-01-12

Publications

• Dichtel LE, Nyer M, Dording C, Fisher LB, Cusin C, Shapero BG, Pedrelli P, Kimball AS, Rao EM, Mischoulon D, Fava M, Miller KK. Effects of Open-Label, Adjunctive Ganaxolone on Persistent Depression Despite Adequate Antidepressant Treatment in Postmenopausal Women: A Pilot Study. J Clin Psychiatry. 2020 Jun 9;81(4):19m12887. doi: 10.4088/JCP.19m12887.

Drugs

Indications