Trial Outcomes & Findings for Biomarker Assessment of Glutamatergic Target Engagement (NCT NCT02134951)

Results Overview

Compare changes in Glx response to infusion of ketamine vs placebo, as measured by proton magnetic resonance spectroscopy (¹H MRS). Calculated by post-pre changes in the Glx over creatinine ratios, with higher values indicating higher Glx/creatinine ratios.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

65 participants

Primary outcome timeframe

Day 1

Results posted on

2018-08-17

Participant Flow

65 subjects were randomized, with results (Number started) reported for the 59 subjects randomized subjects with at least one valid scan

Participant milestones

Participant milestones
Measure	Ketamine IV infusion of ketamine 0.23mg/kg bolus over 1 minutes followed by 0.58 mg/kg/hr over 30 minutes then 0.29mg/kg/hr over 64 minutes Ketamine: intravenous infusion of saline solution with ketamine	Placebo Placebo group will receive normal saline Normal saline: Normal saline will be used for placebo in this group
Overall Study STARTED	39	20
Overall Study COMPLETED	39	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Biomarker Assessment of Glutamatergic Target Engagement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=39 Participants randomized to ketamine	Placebo n=20 Participants randomized to placebo	Total n=59 Participants Total of all reporting groups
Age, Continuous	31.1 years STANDARD_DEVIATION 9.6 • n=5 Participants	32.2 years STANDARD_DEVIATION 10.2 • n=7 Participants	31.5 years STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	16 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	4 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Glx response in 1st 15 minutes post ketamine

Compare changes in Glx response to infusion of ketamine vs placebo, as measured by proton magnetic resonance spectroscopy (¹H MRS). Calculated by post-pre changes in the Glx over creatinine ratios, with higher values indicating higher Glx/creatinine ratios.

Outcome measures

Outcome measures
Measure	Ketamine n=31 Participants IV infusion of ketamine 0.23mg/kg bolus over 1 minutes followed by 0.58 mg/kg/hr over 30 minutes then 0.29mg/kg/hr over 64 minutes Ketamine: intravenous infusion of saline solution with ketamine	Placebo n=16 Participants Placebo group will receive normal saline Normal saline: Normal saline will be used for placebo in this group
Glutamate + Glutamine (Glx) Response	0.015 Glx over creatinine ratio Standard Error .002	0.007 Glx over creatinine ratio Standard Error .003

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 14

Compare changes inpharmacoBOLD in response to infusion of ketamine vs. placebo, as measured by resting state functional magnetic resonance imaging. Calculated by post-pre changes, with higher values indicating higher response

Outcome measures

Outcome measures
Measure	Ketamine n=34 Participants IV infusion of ketamine 0.23mg/kg bolus over 1 minutes followed by 0.58 mg/kg/hr over 30 minutes then 0.29mg/kg/hr over 64 minutes Ketamine: intravenous infusion of saline solution with ketamine	Placebo n=19 Participants Placebo group will receive normal saline Normal saline: Normal saline will be used for placebo in this group
Pharmacological Blood-oxygen-level Dependent (pharmacoBOLD) Response	.91 BOLD signal units Standard Error .1	-0.27 BOLD signal units Standard Error 0.14

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketamine n=39 participants at risk	Placebo n=20 participants at risk
Psychiatric disorders ketamine psychological effect	15.4% 6/39 • Number of events 6	0.00% 0/20

Additional Information

Marlene Carlson

New York State Psychiatric Institute

Phone: 646-774-8436

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place