Trial Outcomes & Findings for Augmentation of Treatment-Resistant Depression With An Analog of the Neuroactive Steroid Allopregnanolone (NCT NCT02900092)

Last Updated: 2019-02-18

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

Week 8

Results posted on

2019-02-18

Participant Flow

Participant milestones

Participant milestones
Measure	Ganaxolone Treatment Arm Participants randomized to ganaxolone treatment
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Ganaxolone Treatment Arm Participants randomized to ganaxolone treatment
Overall Study Adverse Event	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ganaxolone Treatment Arm n=10 Participants Participants received ganaxolone
Age, Continuous	62.8 years STANDARD_DEVIATION 6.3 • n=93 Participants
Sex: Female, Male Female	10 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	10 Participants n=93 Participants
Montgomery-Asberg Depression Rating Scale (MADRS)	24.4 units on a scale STANDARD_DEVIATION 5.1 • n=93 Participants

PRIMARY outcome

Timeframe: Week 8

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

Outcome measures

Outcome measures
Measure	Ganaxolone Treatment Arm n=9 Participants Participants received ganaxolone
Montgomery-Asberg Depression Rating Scale (MADRS)	12.8 units on a scale Standard Deviation 2.9

Adverse Events

Ganaxolone Treatment Arm

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ganaxolone Treatment Arm n=10 participants at risk Participants received ganaxolone treatment
General disorders Sleepiness and fatigue	100.0% 10/10 • 8 weeks
General disorders Dizziness	60.0% 6/10 • 8 weeks

Additional Information

Karen K. Miller, MD

Massachusetts General Hospital

Phone: 617-726-3870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place