Trial Outcomes & Findings for PET Imaging of mGLuR5 With Drug Challenge (NCT NCT01691092)

Results Overview

PET imaging obtained in healthy and Major Depressive Disorder (MDD) subjects. Glutamate levels determined by radiotracer uptake in PET images.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

79 participants

Primary outcome timeframe

1st scan: 90 minute baseline scan; 2nd scan: 90 minutes, ketamine administration at start of scan; scan 3: 90 minute scan 24 hours post ketamine

Results posted on

2017-04-21

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine All subjects will receive ketamine Ketamine: All subjects will receive ketamine to induce glutamate release in the brain
Overall Study STARTED	79
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketamine All subjects will receive ketamine Ketamine: All subjects will receive ketamine to induce glutamate release in the brain
Overall Study Lost to Follow-up	10
Overall Study Physician Decision	4
Overall Study Withdrawal by Subject	3
Overall Study non-compliance	3
Overall Study used for different study	2
Overall Study screen fail	19

Baseline Characteristics

PET Imaging of mGLuR5 With Drug Challenge

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=42 Participants All subjects will receive ketamine Ketamine: All subjects will receive ketamine to induce glutamate release in the brain
Age, Continuous	34.07143 years STANDARD_DEVIATION 12.12615 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
diagnosis Healthy Control (HC)	20 Participants n=5 Participants
diagnosis Major Depressive Disorder (MDD)	14 Participants n=5 Participants
diagnosis Post-Traumatic Stress Disorder (PTSD)	4 Participants n=5 Participants
diagnosis Comorbid MDD & PTSD	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1st scan: 90 minute baseline scan; 2nd scan: 90 minutes, ketamine administration at start of scan; scan 3: 90 minute scan 24 hours post ketamine

Population: 13 healthy (6 males, 7 females) and 14 MDD non-smokers (4 males, 10 females) Mean age: 33.5 ± 13.2 yrs reasons for discrepancy (participant flow module): some data was not able to be analyzed due to elevated metabolites; some subject did not tolerate ketamine and had to be pulled out of scanner so we could not obtain data.

PET imaging obtained in healthy and Major Depressive Disorder (MDD) subjects. Glutamate levels determined by radiotracer uptake in PET images.

Outcome measures

Outcome measures
Measure	Ketamine n=27 Participants All subjects will receive ketamine Ketamine: All subjects will receive ketamine to induce glutamate release in the brain
Change in Glutamate Levels at Baseline and After Ketamine Administration as Confirmed by Positron Emission Tomography (PET) Imaging HC % reduction from baseline immediately post ket	19 percentage reduction Standard Deviation 22
Change in Glutamate Levels at Baseline and After Ketamine Administration as Confirmed by Positron Emission Tomography (PET) Imaging MDD % reduction from baseline immediately post ket	14 percentage reduction Standard Deviation 9
Change in Glutamate Levels at Baseline and After Ketamine Administration as Confirmed by Positron Emission Tomography (PET) Imaging HC % reduction from baseline 24 hrs post ket	31 percentage reduction Standard Deviation 30
Change in Glutamate Levels at Baseline and After Ketamine Administration as Confirmed by Positron Emission Tomography (PET) Imaging MDD % reduction from baseline 24 hrs post ket	14 percentage reduction Standard Deviation 13

Adverse Events

Ketamine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ketamine n=38 participants at risk All subjects will receive ketamine Ketamine: All subjects will receive ketamine to induce glutamate release in the brain
General disorders post-ketamine non-responsiveness	2.6% 1/38 • Number of events 1 • 4 years Standard assessments and regular observations are used to determine whether or not certain adverse events have occurred.

Other adverse events

Adverse event data not reported

Additional Information

Irina Esterlis, Ph.D.

Yale University - Psychiatry Department

Phone: (203)737-6820

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place