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

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ClinicalTrials.gov Identifier: NCT02900092

Recruitment Status : Completed

First Posted : September 14, 2016

Results First Posted : February 18, 2019

Last Update Posted : February 18, 2019

Sponsor:

Information provided by (Responsible Party):

Karen Klahr Miller, MD, Massachusetts General Hospital

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Major Depressive Disorder
Intervention	Drug: Ganaxolone
Enrollment	10

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Ganaxolone Treatment Arm
Arm/Group Description	Participants randomized to ganaxolo...
Arm/Group Description	Participants randomized to ganaxolone treatment
Period Title: Overall Study
Started	10
Completed	9
Not Completed	1
Reason Not Completed
Adverse Event	1

Baseline Characteristics

Arm/Group Title		Ganaxolone Treatment Arm
Arm/Group Description		Participants received ganaxolone
Arm/Group Description		Participants received ganaxolone
Overall Number of Baseline Participants		10
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	10 participants
		62.8 (6.3)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	10 participants
	Female	10 100.0%
	Male	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	10 participants
	American Indian or Alaska Native	0 0.0%
	Asian	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	10 100.0%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants
United States	Number Analyzed	10 participants
United States		10 100.0%
Montgomery-Asberg Depression Rating Scale (MADRS) ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	10 participants
		24.4 (5.1)
		[1] Measure Description: 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)

Outcome Measures

1.Primary Outcome


Title	Montgomery-Asberg Depression Rating Scale (MADRS)
Description	The MADRS is a diagnostic questionnaire that is used to measure the se...
Description	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).
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

Ten subjects started the study. One subject dropped out (did not complete the 8-week study). Therefore, data from 9 subjects were analyzed.


Arm/Group Title	Ganaxolone Treatment Arm
Arm/Group Description:	Participants received ganaxolone
Arm/Group Description:	Participants received ganaxolone
Overall Number of Participants Analyzed	9
Mean (Standard Deviation) Unit of Measure: units on a scale
	12.8 (2.9)

Adverse Events

Time Frame	8 weeks
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Ganaxolone Treatment Arm
Arm/Group Description	Participants received ganaxolone tr...
Arm/Group Description	Participants received ganaxolone treatment
All-Cause Mortality
	Ganaxolone Treatment Arm
	Affected / at Risk (%)
Total	0/10 (0.00%)
Serious Adverse Events Serious Adverse Events
	Ganaxolone Treatment Arm
	Affected / at Risk (%)
Total	0/10 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Ganaxolone Treatment Arm
	Affected / at Risk (%)
Total	10/10 (100.00%)
General disorders
Sleepiness and fatigue ^†	10/10 (100.00%)
Dizziness ^†	6/10 (60.00%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Karen K. Miller, MD
Organization:	Massachusetts General Hospital
Phone:	617-726-3870
EMail:	KKMiller@mgh.harvard.edu

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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). pii: 19m12887. doi: 10.4088/JCP.19m12887.

Layout table for additonal information

Responsible Party:	Karen Klahr Miller, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT02900092
Other Study ID Numbers:	2016P001182
First Submitted:	September 9, 2016
First Posted:	September 14, 2016
Results First Submitted:	January 15, 2019
Results First Posted:	February 18, 2019
Last Update Posted:	February 18, 2019

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