Trial Outcomes & Findings for Repeated Neurocognitive Measurements in Depressed Patients (NCT NCT04916548)

Results Overview

functional connectivity normalized correlation values within default mode network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

24hrs post-intervention

Results posted on

2024-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Intravenous Ketamine Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Repeated Neurocognitive Measurements in Depressed Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intravenous Ketamine n=15 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Age, Continuous	33.47 years STANDARD_DEVIATION 11.14 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Montgomery-Asberg Depression Rating Scale	30.20 score on a scale STANDARD_DEVIATION 9.29 • n=5 Participants

PRIMARY outcome

Timeframe: 24hrs post-intervention

Population: All participants who received a ketamine infusion

functional connectivity normalized correlation values within default mode network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=15 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
fMRI Intrinsic Connectivity: Default Mode Network	0.40 units on a scale Standard Deviation 0.11

PRIMARY outcome

Timeframe: 24hrs post-intervention

Population: All participants who received a ketamine infusion

functional connectivity normalized correlation values within frontoparietal control network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=15 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
fMRI Intrinsic Connectivity: Frontoparietal Control Network	0.47 units on a scale Standard Deviation 0.14

PRIMARY outcome

Timeframe: 24hrs post-intervention

Population: All participants who received a ketamine infusion

functional connectivity normalized correlation values within limbic network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=15 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
fMRI Intrinsic Connectivity: Limbic Network	0.44 units on a scale Standard Deviation 0.10

PRIMARY outcome

Timeframe: 24hrs post-intervention

Population: All participants who received a ketamine infusion

functional connectivity normalized correlation values within salience ventral attentional network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=15 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
fMRI Intrinsic Connectivity: Salience Network	0.53 units on a scale Standard Deviation 0.13

SECONDARY outcome

Timeframe: 24hrs post-intervention

Population: All participants who received a ketamine infusion

functional connectivity normalized correlation values within dorsal attention network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=15 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
fMRI Intrinsic Connectivity: Dorsal Attention Network	0.54 units on a scale Standard Deviation 0.11

SECONDARY outcome

Timeframe: 24hrs post-intervention

Population: All participants who received a ketamine infusion

functional connectivity normalized correlation values within somatosensory motor network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=15 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
fMRI Intrinsic Connectivity: Somatosensory Motor Network	0.69 units on a scale Standard Deviation 0.10

SECONDARY outcome

Timeframe: 24hrs post-intervention

Population: All participants who received a ketamine infusion

functional connectivity normalized correlation values within visual network (range: -1 to +1; larger value = stronger connectivity, smaller value = weaker connectivity)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=15 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
fMRI Intrinsic Connectivity: Visual Network	0.60 units on a scale Standard Deviation 0.08

SECONDARY outcome

Timeframe: 24hrs post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-60; higher scores = worse outcome)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=15 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Montgomery-Asberg Depression Rating Scale	11.80 score on a scale Standard Deviation 7.55

SECONDARY outcome

Timeframe: 5 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-60; higher scores = worse outcome)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=15 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Montgomery-Asberg Depression Rating Scale	15.00 score on a scale Standard Deviation 10.45

SECONDARY outcome

Timeframe: 12 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-60; higher scores = worse outcome)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=14 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Montgomery-Asberg Depression Rating Scale	19.93 score on a scale Standard Deviation 13.57

SECONDARY outcome

Timeframe: 24hrs post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-52; higher scores = worse outcome)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=15 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Hamilton Depression Rating Scale (Modified Score)	7.53 score on a scale Standard Deviation 3.89

SECONDARY outcome

Timeframe: 5 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-52; higher scores = worse outcome)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=15 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Hamilton Depression Rating Scale (Modified Score)	11.07 score on a scale Standard Deviation 7.07

SECONDARY outcome

Timeframe: 12 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Clinician-rated depression (range: 0-52; higher scores = worse outcome)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=14 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Hamilton Depression Rating Scale (Modified Score)	13.07 score on a scale Standard Deviation 8.00

SECONDARY outcome

Timeframe: 24hrs post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Self-reported depression (range: 0-27; higher scores = worse outcome)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=15 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Quick Inventory of Depressive Symptoms	6.87 score on a scale Standard Deviation 4.60

SECONDARY outcome

Timeframe: 5 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Self-reported depression (range: 0-27; higher scores = worse outcome)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=14 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Quick Inventory of Depressive Symptoms	6.79 score on a scale Standard Deviation 4.09

SECONDARY outcome

Timeframe: 12 days post-intervention

Population: All participants who were assigned to the arm and were willing and able to complete this specific measure.

Self-reported depression (range: 0-27; higher scores = worse outcome)

Outcome measures

Outcome measures
Measure	Intravenous Ketamine n=14 Participants Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Quick Inventory of Depressive Symptoms	9.71 score on a scale Standard Deviation 5.59

OTHER_PRE_SPECIFIED outcome

Timeframe: infusion +24 hours (1 day)

Other adverse events

Other adverse events
Measure	Intravenous Ketamine n=15 participants at risk Open-label ketamine infusion Intravenous Ketamine: Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
General disorders decreased energy	6.7% 1/15 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Psychiatric disorders difficulty sleeping: too little	6.7% 1/15 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Psychiatric disorders dissociative symptoms	93.3% 14/15 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Nervous system disorders dizziness	53.3% 8/15 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Gastrointestinal disorders dry mouth	40.0% 6/15 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Psychiatric disorders emotional indifference	6.7% 1/15 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Nervous system disorders headache	6.7% 1/15 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Gastrointestinal disorders increased appetite	26.7% 4/15 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Reproductive system and breast disorders loss of sexual desire	6.7% 1/15 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Gastrointestinal disorders nausea	26.7% 4/15 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
General disorders restlessness	6.7% 1/15 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
General disorders sweating	26.7% 4/15 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Nervous system disorders tremors	6.7% 1/15 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.
Reproductive system and breast disorders trouble achieving orgasm	6.7% 1/15 • 24 hours Adverse events were collected using the Patient Rated Inventory of Side Effects (PRISE; Rush et al 2004) instrument and the Clinician-Administered Dissociative States Scale (CADSS). Open-ended questions were also used to inquire about any additional adverse events not captured on the PRISE. Adverse events were tallied for all symptoms that were reported as new or worsening from pre-infusion baseline with onset during the infusion and/or within the subsequent 24hr period.

Additional Information

Dr. Rebecca Price

University of Pittsburgh

Phone: 412-383-2150

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place