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

• Status: Completed
• Trial end date: 2018-01-12
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Ganaxolone; Pregnanolone

Criteria

Inclusion Criteria:

1. Female, age 50-75

2. Postmenopausal

3. Major Depressive Disorder

4. Currently treated with SSRI or SNRI at adequate dose

Exclusion Criteria:

1. Serious suicide or homicide risk

2. Unstable medical illness

3. Substance use disorder

4. Psychosis

5. Use of hormones (estrogens, androgens or related hormones)

6. History of hormone responsive cancer

7. Receiving strong CYP3A4 inducers or inhibitors or who intend to consume grapefruit products regularly during the study

8. Alanine aminotransferase (ALT) or creatinine > 3x upper limit of normal