At a glance
ClinicalIndex Comparison Record- ✓Female, age 50-75
- ✓Postmenopausal status
- ✓Major Depressive Disorder diagnosis
- ✓Currently treated with SSRI or SNRI at adequate dose
- ✕Serious suicide or homicide risk
- ✕Unstable medical illness
- ✕Substance use disorder
- ✕Psychosis
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment-Resistant Depression Augmentation Therapy With An Analog of the Neuroactive Steroid Allopregnanolone: A Pilot Study
In Brief
A clinical study evaluating Ganaxolone for Major Depressive Disorder. Completed, enrolled 10 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Participants received ganaxolone