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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ganaxolone Treatment Arm
Hide 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
Arm/Group Title Ganaxolone Treatment Arm
Hide Arm/Group Description Participants received ganaxolone
Overall Number of Baseline Participants 10
Hide 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
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)
1.Primary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS)
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ganaxolone Treatment Arm
Hide Arm/Group Description Participants received ganaxolone treatment
All-Cause Mortality
Ganaxolone Treatment Arm
Affected / at Risk (%)
Total   0/10 (0.00%) 
Hide Serious Adverse Events
Ganaxolone Treatment Arm
Affected / at Risk (%)
Total   0/10 (0.00%) 
Hide 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
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
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