Trial Outcomes & Findings for The Sustained Effects of Ketamine (NCT NCT02708849)
NCT ID: NCT02708849
Last Updated: 2020-07-02
Results Overview
24 hours post infusion fMRI data
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
3 participants
Primary outcome timeframe
24 hours
Results posted on
2020-07-02
Participant Flow
Participant milestones
| Measure |
Ketamine Plus Lamotrigine
Ketamine: The subanesthetic dose of ketamine (0.23mg/kg bolus followed by 0.58mg/kg infusion over approximately 60 minutes) will be administered via intravenous infusion
Lamotrigine: lamotrigine (300 mg oral dose) or the matched-placebo control about 2-hours prior to the start of the infusion of ketamine
|
Ketamine Plus Placebo
Ketamine: The subanesthetic dose of ketamine (0.23mg/kg bolus followed by 0.58mg/kg infusion over approximately 60 minutes) will be administered via intravenous infusion
Placebo: oral dose placebo
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Sustained Effects of Ketamine
Baseline characteristics by cohort
| Measure |
Ketamine Plus Lamotrigine
n=2 Participants
Ketamine: The subanesthetic dose of ketamine (0.23mg/kg bolus followed by 0.58mg/kg infusion over approximately 60 minutes) will be administered via intravenous infusion
Lamotrigine: lamotrigine (300 mg oral dose) or the matched-placebo control about 2-hours prior to the start of the infusion of ketamine
|
Ketamine Plus Placebo
n=1 Participants
Ketamine: The subanesthetic dose of ketamine (0.23mg/kg bolus followed by 0.58mg/kg infusion over approximately 60 minutes) will be administered via intravenous infusion
Placebo: oral dose placebo
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
NA years
STANDARD_DEVIATION NA • n=99 Participants
|
NA years
STANDARD_DEVIATION NA • n=107 Participants
|
40 years
STANDARD_DEVIATION 7.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
3 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Imaging data were not extracted to protect confidentiality of participants.
24 hours post infusion fMRI data
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 hoursPopulation: Insufficient number of participants for data collection
Participants will be randomized into one of two parallel groups-ketamine+lamotrigine or ketamine+placebo-and will complete pre- and post-ketamine rs-fMRI. The hypothesis is that post-ketamine rs-fMRI data will demonstrate a pattern of increased global brain connectivity (GBC) in fronto-temporal cortex. Insufficient number of participants for data collection.
Outcome measures
Outcome data not reported
Adverse Events
Ketamine Plus Lamotrigine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ketamine Plus 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
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place