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Clinical Trial Details — Status: Not yet recruiting

Administrative data

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

Study information

Verified date May 2016
Source Massachusetts General Hospital
Contact Molly Snell
Phone 617-726-2764
Email msnell1@partners.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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. Investigators hypothesize that administration of an allopregnanolone analog in women with treatment-resistant depression will improve depressive symptoms.


Description:

Major depressive disorder (MDD) is highly prevalent and can have profoundly negative consequences on one's health, well-being and productivity. Women are twice as likely as men to experience depression during their lifetimes. In fact, it is reported that twelve million women in the U.S. each year will experience depression, and that one in eight women will experience a clinical depressive episode during their lifetimes. Additionally, nearly 70% of individuals with MDD do not respond to standard antidepressant therapies despite adequate dosing. Therefore, the identification of 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. Specifically, allopregnanolone, a steroid hormone derived from progesterone, is a potent positive modulator of GABA action at GABA-A receptors, which are known to have positive effects on mood symptoms. Data suggest that depression, chronic stress and posttraumatic stress disorder may be associated with low central nervous system allopregnanolone levels.

Investigators propose to administer an oral allopregnanolone analog to 10 postmenopausal women with treatment-resistant depression as an add-on therapy to their current treatment for a period of two months. Investigators hypothesize that administration of the oral allopregnanolone analog in women with treatment-resistant depression will improve depressive symptoms.


Recruitment information / eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
CCD-1042
CCD-1042 at an oral dose of 225mg BID with uptitration to 450mg BID as tolerated for the duration of the 8 week trial. There is no other intervention in this one arm, open label trial.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Montgomery Asberg Depression Rating Scale Baseline and 8 week No
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