Major Depressive Disorder Clinical Trial
Official title:
Treatment-Resistant Depression Augmentation Therapy With An Analog of the Neuroactive Steroid Allopregnanolone: A Pilot Study
NCT number | NCT02766920 |
Other study ID # | NAS-2016 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | May 4, 2016 |
Last updated | May 9, 2016 |
Start date | September 2016 |
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. Investigators hypothesize that administration of an allopregnanolone analog in women with treatment-resistant depression will improve depressive symptoms.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 75 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Montgomery Asberg Depression Rating Scale | Baseline and 8 week | No |
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