Trial Outcomes & Findings for Low Dose Intravenous Ketamine in Treatment Resistant Depression Patients (NCT NCT02935595)

Results Overview

Transcranial magnetic stimulation (TMS) of the left dorsolateral prefrontal cortex (DLPFC) was performed, and electroencephalography (EEG) recording was performed during TMS stimulation. Data is reported as the local mean field amplitude-area under the curve (LMFA-AUC) from a subset of EEG electrodes around the TMS stimulation site.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Baseline

Results posted on

2022-01-13

Participant Flow

3 subjects signed consent and were screened, but met exclusion criteria and were thus excluded from the study before starting. 1 subject withdrew consent after screening and did not start the study.

Participant milestones

Participant milestones
Measure	Ketamine Slow infusions of ketamine will take place over a time period of 40 minutes. Ketamine: Ketamine Hydrochloride Injection
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race data was not collected from 1 participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=5 Participants Slow infusions of ketamine will take place over a time period of 40 minutes. Ketamine: Ketamine Hydrochloride Injection
Age, Continuous	40.20 years STANDARD_DEVIATION 10.38 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants • Race data was not collected from 1 participant.
Race (NIH/OMB) Asian	0 Participants n=4 Participants • Race data was not collected from 1 participant.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants • Race data was not collected from 1 participant.
Race (NIH/OMB) Black or African American	0 Participants n=4 Participants • Race data was not collected from 1 participant.
Race (NIH/OMB) White	4 Participants n=4 Participants • Race data was not collected from 1 participant.
Race (NIH/OMB) More than one race	0 Participants n=4 Participants • Race data was not collected from 1 participant.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants • Race data was not collected from 1 participant.
Region of Enrollment United States	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Data was not collected for one participant.

Transcranial magnetic stimulation (TMS) of the left dorsolateral prefrontal cortex (DLPFC) was performed, and electroencephalography (EEG) recording was performed during TMS stimulation. Data is reported as the local mean field amplitude-area under the curve (LMFA-AUC) from a subset of EEG electrodes around the TMS stimulation site.

Outcome measures

Outcome measures
Measure	Ketamine n=4 Participants Slow infusions of ketamine will take place over a time period of 40 minutes. Ketamine: Ketamine Hydrochloride Injection
Cortical Excitability in the Dorsolateral Prefrontal Cortex (DLPFC) as Assessed by Transcranial Magnetic Stimulation-evoked Activity Detected by Electroencephalography (TMS-EEG)	446.08 microvolt * milliseconds (µV * ms) Standard Deviation 209.13

PRIMARY outcome

Timeframe: 4 hours

Population: Data was not collected for 1 participant.

Transcranial magnetic stimulation (TMS) of the left dorsolateral prefrontal cortex (DLPFC) was performed, and electroencephalography (EEG) recording was performed during TMS stimulation. Data is reported as the local mean field amplitude-area under the curve (LMFA-AUC) from a subset of EEG electrodes around the TMS stimulation site.

Outcome measures

Outcome measures
Measure	Ketamine n=4 Participants Slow infusions of ketamine will take place over a time period of 40 minutes. Ketamine: Ketamine Hydrochloride Injection
Cortical Excitability in DLPFC Using TMS-EEG	319.71 microvolt * milliseconds (µV * ms) Standard Deviation 206.04

PRIMARY outcome

Timeframe: 24 hours

Population: Data was not collected for 1 participant.

Transcranial magnetic stimulation (TMS) of the left dorsolateral prefrontal cortex (DLPFC) was performed, and electroencephalography (EEG) recording was performed during TMS stimulation. Data is reported as the local mean field amplitude-area under the curve (LMFA-AUC) from a subset of EEG electrodes around the TMS stimulation site.

Outcome measures

Outcome measures
Measure	Ketamine n=4 Participants Slow infusions of ketamine will take place over a time period of 40 minutes. Ketamine: Ketamine Hydrochloride Injection
Cortical Excitability in DLPFC Using TMS-EEG	330.30 microvolt * milliseconds (µV * ms) Standard Deviation 222.45

PRIMARY outcome

Timeframe: 7 days

Population: Data was not collected from any participant at 7 days.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Population: Data was not collected for one participant.

Total MADRS score ranges from 0 to 60, and a higher score indicates more severe depression, as follows: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression

Outcome measures

Outcome measures
Measure	Ketamine n=4 Participants Slow infusions of ketamine will take place over a time period of 40 minutes. Ketamine: Ketamine Hydrochloride Injection
Severity of Depressive Symptoms as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)	24.50 units on a scale Standard Deviation 7.09

SECONDARY outcome

Timeframe: 4 hours

Population: Data was not collected for one participant.

Total MADRS score ranges from 0 to 60, and a higher score indicates more severe depression, as follows: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression

Outcome measures

Outcome measures
Measure	Ketamine n=4 Participants Slow infusions of ketamine will take place over a time period of 40 minutes. Ketamine: Ketamine Hydrochloride Injection
Severity of Depressive Symptoms as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)	22.5 units on a scale Standard Deviation 9.73

SECONDARY outcome

Timeframe: 24 hours

Population: Data was not collected for one participant.

Total MADRS score ranges from 0 to 60, and a higher score indicates more severe depression, as follows: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression

Outcome measures

Outcome measures
Measure	Ketamine n=4 Participants Slow infusions of ketamine will take place over a time period of 40 minutes. Ketamine: Ketamine Hydrochloride Injection
Severity of Depressive Symptoms as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS)	16.25 units on a scale Standard Deviation 7.66

SECONDARY outcome

Timeframe: 24 hours

Outcome measures

Outcome measures
Measure	Ketamine n=5 Participants Slow infusions of ketamine will take place over a time period of 40 minutes. Ketamine: Ketamine Hydrochloride Injection
Safety as Indicated by Number of Adverse Events	1 adverse events

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=5 participants at risk Slow infusions of ketamine will take place over a time period of 40 minutes. Ketamine: Ketamine Hydrochloride Injection
Psychiatric disorders Depersonalization	20.0% 1/5 • Number of events 1 • 24 hours

Additional Information

Sudhakar Selvaraj, MD, PhD, Assistant Professor

The University of Texas Health Science Center at Houston

Phone: (713) 486-2500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place