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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 : 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 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%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ganaxolone Treatment Arm
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events 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
Name/Title: Karen K. Miller, MD
Organization: Massachusetts General Hospital
Phone: 617-726-3870
Responsible Party: Karen Klahr Miller, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02900092     History of Changes
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