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

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ClinicalTrials.gov Identifier: NCT02900092
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: CCD-1042 Not Applicable

Detailed 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. The 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 8 weeks followed by a 2-week taper. The investigators hypothesize that administration of the oral allopregnanolone analog in women with treatment-resistant depression will improve depressive symptoms.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment-Resistant Depression Augmentation Therapy With An Analog of the Neuroactive Steroid Allopregnanolone: A Pilot Study
Study Start Date : November 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: CCD-1042 Treatment Arm
CCD-1042 at an oral dose of 225mg BID with uptitration to 450mg BID as tolerated for the duration of the 8 week trial.
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.



Primary Outcome Measures :
  1. Change in Montgomery-Asberg Depression (MADRS) Scale [ Time Frame: 8 week ]


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900092


Contacts
Contact: Molly Snell 617-726-2764 msnell1@partners.org
Contact: Laura Dichtel, MD, MHS 617-724-3614 ldichtel@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Laura Dichtel, MD    617-726-3870    LDichtel@partners.org   
Principal Investigator: Karen K Miller, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Karen K Miller, MD Massachusetts General Hospital

Responsible Party: Karen Klahr Miller, MD, Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02900092     History of Changes
Other Study ID Numbers: 2016P001182
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Karen Klahr Miller, MD, Massachusetts General Hospital:
postmenopausal
women
depression

Additional relevant MeSH terms:
Depressive Disorder, Major
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pregnanolone
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs