Trial Outcomes & Findings for Ketamine for Depression: An MRI Study (NCT NCT02544607)

Last Updated: 2019-04-16

Results Overview

Hamilton Depression Rating Scale; possible scores range from 0 to 81 with higher scores indicating higher depression symptoms Change will be calculated by difference between HDRS from Minute 0 to Minute 240.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

4 hours

Results posted on

2019-04-16

Participant Flow

As specified, the total number of participants enrolled are those who agreed to participate in the study following completion of the informed consent process (n=25). This number does not reflect the number of subjects who actually started treatment (n=16).

Participant milestones

Participant milestones
Measure	Ketamine + MRI All eligible participants will receive open label ketamine and undergo Magnetic Resonance Imaging Ketamine: Ketamine 0.5mg/kg over 40 minutes IV
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ketamine for Depression: An MRI Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=16 Participants All eligible participants will receive open label ketamine Ketamine: Ketamine 0.5mg/kg over 40 minutes IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	42 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	14 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 hours

Outcome measures

Outcome measures
Measure	Ketamine n=16 Participants All eligible participants will receive open label ketamine Ketamine: Ketamine 0.5mg/kg over 40 minutes IV
Change in Hamilton Depression Rating Scale (HDRS) From Baseline/Minute 0 to 4 Hours Post-infusion.	-9.625 score on a scale Interval -25.0 to 6.0

SECONDARY outcome

Timeframe: 4 hours

Population: Reasons for missing data (N=3) included a scanner malfunction and participant requests to stop scanning prior to dMRI sequence acquisition.

Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion

Outcome measures

Outcome measures
Measure	Ketamine n=13 Participants All eligible participants will receive open label ketamine Ketamine: Ketamine 0.5mg/kg over 40 minutes IV
Percent Change in Tissue Fractional Anisotropy Quantification (Left Inferior Longitudinal Fasciculus)	.901 percent change

SECONDARY outcome

Timeframe: 4 hours

Population: Reasons for missing data (N=3) included a scanner malfunction and participant requests to stop scanning prior to dMRI sequence acquisition.

Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion

Outcome measures

Outcome measures
Measure	Ketamine n=13 Participants All eligible participants will receive open label ketamine Ketamine: Ketamine 0.5mg/kg over 40 minutes IV
Percent Change in Tissue Fractional Anisotropy Quantification (Right Inferior Longitudinal Fasciculus)	1.247 percent change

SECONDARY outcome

Timeframe: 4 hours

Population: Reasons for missing data (N=3) included a scanner malfunction and participant requests to stop scanning prior to dMRI sequence acquisition.

Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion

Outcome measures

Outcome measures
Measure	Ketamine n=13 Participants All eligible participants will receive open label ketamine Ketamine: Ketamine 0.5mg/kg over 40 minutes IV
Percent Change in Tissue Fractional Anisotropy Quantification (Left Superior Longitudinal Fasciculus)	.696 percent change

SECONDARY outcome

Timeframe: 4 hours

Population: Reasons for missing data (N=3) included a scanner malfunction and participant requests to stop scanning prior to dMRI sequence acquisition.

Free-water imaging, a two-compartment diffusion model, was employed to quantify tissue fractional anisotropy (FAt) pre- and post-infusion

Outcome measures

Outcome measures
Measure	Ketamine n=13 Participants All eligible participants will receive open label ketamine Ketamine: Ketamine 0.5mg/kg over 40 minutes IV
Percent Change in Tissue Fractional Anisotropy Quantification (Right Uncinate Fasciculus)	1.158 percent change

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketamine n=16 participants at risk All eligible participants will receive open label ketamine Ketamine: Ketamine 0.5mg/kg over 40 minutes IV
Eye disorders bilateral nystagmus	6.2% 1/16 • Adverse event data were collected throughout the course of the study. The collection of this data took place at the initial screen, continuously throughout the duration of the administration visit (e.g. Visit 2), 24 hours post-administration, and up to 3 months following the administration visit.

Additional Information

Dr. Cristina Cusin

Massachusetts General Hospital

Phone: 617-726-6421

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place