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

NCT02900092 | Completed Results DMC

• 1 other identifier: 2016P001182
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

postmenopausal; women; depression

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  The MADRS is a diagnostic questionnaire that is used to measure the severity of depressive episodes in patients with mood disorders. The minimum and maximum values are 0 and 60, respectively, (higher scores are more severe).

  Week 8

Study Arms (1)

Ganaxolone

EXPERIMENTAL

Participants received ganaxolone

Drug: Ganaxolone

Interventions

Ganaxolone DRUG

Participants received ganaxolone

Ganaxolone

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, age 50-75
• Postmenopausal
• Major Depressive Disorder
• Currently treated with SSRI or SNRI at adequate dose

You may not qualify if:

• Serious suicide or homicide risk
• Unstable medical illness
• Substance use disorder
• Psychosis
• Use of hormones (estrogens, androgens or related hormones)
• History of hormone responsive cancer
• Receiving strong CYP3A4 inducers or inhibitors or who intend to consume grapefruit products regularly during the study
• Alanine aminotransferase (ALT) or creatinine \> 3x upper limit of normal

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Dichtel LE, Nyer M, Dording C, Fisher LB, Cusin C, Shapero BG, Pedrelli P, Kimball AS, Rao EM, Mischoulon D, Fava M, Miller KK. Effects of Open-Label, Adjunctive Ganaxolone on Persistent Depression Despite Adequate Antidepressant Treatment in Postmenopausal Women: A Pilot Study. J Clin Psychiatry. 2020 Jun 9;81(4):19m12887. doi: 10.4088/JCP.19m12887.

  PMID: 32558402 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

ganaxolone

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Karen K. Miller, MD
• Organization: Massachusetts General Hospital

KKMiller@mgh.harvard.edu

617-726-3870

Study Officials

• Karen K Miller, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: September 9, 2016
• First Posted: September 14, 2016
• Study Start: November 1, 2016
• Primary Completion: January 12, 2018
• Study Completion: January 12, 2018
• Last Updated: February 18, 2019
• Results First Posted: February 18, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)