Trial Outcomes & Findings for Anesthesia and Functional Connectivity: An Analysis of fMRI Changes (NCT NCT02196259)
NCT ID: NCT02196259
Last Updated: 2017-05-02
Results Overview
The imaging experiments and analysis of subject-specific data will lead to maps corresponding to separate measures: resting state functional connectivity maps. The outcome of interest is whether ketamine reduces functional connectivity between the anterior (subgenual anterior cingulate corte, sgACC) and posterior regions (posterior cingulate cortex, PCC) of the default mode network. This is the z-score of the functional connectivity correlation. Timepoints for Initial fMRI were: Time 1:Immediately before Infusion, Time 2: After washout (Approx. 40 min after end of infusion). Timepoints for Depression were: Time 1: 1 Day before Infusion, Time 2: 1 Day after Infusion
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
8 minutes scans, acquired between 1 day and 3 days (see above)
Results posted on
2017-05-02
Participant Flow
3 participants were screened out.
Participant milestones
| Measure |
Initial MRI
The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
|
Hospital
|
Depresssion
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
7
|
3
|
|
Overall Study
COMPLETED
|
3
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
Initial MRI
The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
|
Hospital
|
Depresssion
|
|---|---|---|---|
|
Overall Study
Researcher choice
|
0
|
0
|
1
|
|
Overall Study
Partial data analysis
|
0
|
3
|
0
|
Baseline Characteristics
Anesthesia and Functional Connectivity: An Analysis of fMRI Changes
Baseline characteristics by cohort
| Measure |
Initial MRI
n=3 Participants
The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
|
Initial Hospital
n=7 Participants
The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
|
Depression
n=3 Participants
The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
7 participants
n=7 Participants
|
3 participants
n=5 Participants
|
13 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 8 minutes scans, acquired between 1 day and 3 days (see above)Population: Primary outcome measure is functional connectivity as measured using the MRI scans, which is only in the Initial MRI and Depression Arms.
The imaging experiments and analysis of subject-specific data will lead to maps corresponding to separate measures: resting state functional connectivity maps. The outcome of interest is whether ketamine reduces functional connectivity between the anterior (subgenual anterior cingulate corte, sgACC) and posterior regions (posterior cingulate cortex, PCC) of the default mode network. This is the z-score of the functional connectivity correlation. Timepoints for Initial fMRI were: Time 1:Immediately before Infusion, Time 2: After washout (Approx. 40 min after end of infusion). Timepoints for Depression were: Time 1: 1 Day before Infusion, Time 2: 1 Day after Infusion
Outcome measures
| Measure |
Initial MRI
n=3 Participants
The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
|
Depression
n=2 Participants
The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
|
|---|---|---|
|
Functional Connectivity
Before Infusion sgACC-PCC connectivity
|
0.3114 z score
Standard Error 0.2199
|
0.3459 z score
Standard Error 0.018
|
|
Functional Connectivity
After Infusion sgACC-PCC connectivity
|
-0.4424 z score
Standard Error 0.29
|
0.3208 z score
Standard Error 0.0465
|
Adverse Events
Initial fMRI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hospital
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Depression
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Initial fMRI
n=3 participants at risk
The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
|
Hospital
n=7 participants at risk
The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
|
Depression
n=3 participants at risk
The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
|
|---|---|---|---|
|
Psychiatric disorders
Discomfort
|
0.00%
0/3 • Subjects were followed up for possible adverse events up to 4 weeks after the final infusion session.
describe monitoring of subjects for adverse symptoms
|
0.00%
0/7 • Subjects were followed up for possible adverse events up to 4 weeks after the final infusion session.
describe monitoring of subjects for adverse symptoms
|
33.3%
1/3 • Subjects were followed up for possible adverse events up to 4 weeks after the final infusion session.
describe monitoring of subjects for adverse symptoms
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place