Trial Outcomes & Findings for Physiological and Cognitive Biomarkers for Ketamine's Antidepressant Effects (NCT NCT02669043)

Last Updated: 2018-04-23

Results Overview

Continuous score of depression symptoms. The higher the score, the more severe the depression. HAMD scores range from 0 to 81.

Recruitment status

TERMINATED

Study phase

Target enrollment

8 participants

Primary outcome timeframe

48 hours

Results posted on

2018-04-23

Participant milestones
Measure	Ketamine All participants receive open-label ketamine Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes
Overall Study STARTED	8
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	4

Reasons for withdrawal
Measure	Ketamine All participants receive open-label ketamine Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes
Overall Study Didn't meet I/E criteria	4

Physiological and Cognitive Biomarkers for Ketamine's Antidepressant Effects

Baseline characteristics by cohort
Measure	Ketamine n=8 Participants All participants receive open-label ketamine Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	48.3 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants
HAMD Total Score	28.5 units on a scale n=5 Participants

Timeframe: 48 hours

Population: Patients who completed the study. Outcome measure was at 48 hours.

Continuous score of depression symptoms. The higher the score, the more severe the depression. HAMD scores range from 0 to 81.

Outcome measures
Measure	Ketamine n=4 Participants All participants receive open-label ketamine Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes
Hamilton Depression Rating Scale (HDRS, HAM-D)	11.5 units on a scale Interval 5.0 to 27.0

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Massachusetts General Hospital

Phone: 617-726-6421