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
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Sponsor:
Massachusetts General Hospital
Information provided by (Responsible Party):
Karen Klahr Miller, MD, Massachusetts General Hospital
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Study Type | Interventional |
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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 |
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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 | |
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Participants received ganaxolone | |
Overall Number of Baseline Participants | 10 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 10 participants | |
62.8 (6.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 10 participants | |
Female |
10 100.0%
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Male |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 10 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
10 100.0%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 10 participants |
10 100.0%
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Montgomery-Asberg Depression Rating Scale (MADRS)
[1] Mean (Standard Deviation) Unit of measure: Units on a scale |
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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)
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
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):
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 |