Trial Outcomes & Findings for Ketamine as a Rapidly-Acting Antidepressant in Depressed Emergency Department Patients (NCT NCT02106325)

NCT ID: NCT02106325

Last Updated: 2018-09-14

Results Overview

40 Minutes Post Infusion, The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 54 points. 0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 21 participants
• Primary outcome timeframe: Baseline and 16 weeks
• Results posted on: 2018-09-14

Participant Flow

Participant milestones

Measure	Ketamine IV Ketamine .25mg/kg Ketamine: IV of Ketamine (.25mg/kg)	Diphenhydramine 25mg Diphenhydramine Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
Phase 1 STARTED	5	3
Phase 1 COMPLETED	3	1
Phase 1 NOT COMPLETED	2	2
Phase 2 STARTED	4	4
Phase 2 COMPLETED	2	1
Phase 2 NOT COMPLETED	2	3
Phase 3 STARTED	2	3
Phase 3 COMPLETED	0	2
Phase 3 NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Ketamine IV Ketamine .25mg/kg Ketamine: IV of Ketamine (.25mg/kg)	Diphenhydramine 25mg Diphenhydramine Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
Phase 1 Lost to Follow-up	2	2
Phase 2 Lost to Follow-up	2	3
Phase 3 Lost to Follow-up	2	1

Baseline Characteristics

Ketamine as a Rapidly-Acting Antidepressant in Depressed Emergency Department Patients

Baseline characteristics by cohort

Measure	Ketamine n=11 Participants IV Ketamine .25mg/kg Ketamine: IV of Ketamine (.25mg/kg)	Diphenhydramine n=10 Participants 25mg Diphenhydramine Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department	Total n=21 Participants Total of all reporting groups
Age, Continuous	40 years n=5 Participants	31 years n=7 Participants	38 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 16 weeks

40 Minutes Post Infusion, The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 54 points.

0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression.

Outcome measures

Measure	Ketamine n=11 Participants IV Ketamine .25mg/kg Ketamine: IV of Ketamine (.25mg/kg)	Diphenhydramine n=10 Participants 25mg Diphenhydramine Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
Evaluate the Effects of Ketamine on Depressive Symptomatology by Measuring Change in Score on the Montgomery-Asberg Depressive Rating Scale	28.82 units on a scale Standard Error 2.95	25.20 units on a scale Standard Error 3.10

PRIMARY outcome

Timeframe: 120 min post-infusion

BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.

0-13 Indicates minimal depression 14-19 Indicates mild depression 20-28 Indicates Moderate depression 29-63 Indicates Severe depression

Outcome measures

Measure	Ketamine n=11 Participants IV Ketamine .25mg/kg Ketamine: IV of Ketamine (.25mg/kg)	Diphenhydramine n=10 Participants 25mg Diphenhydramine Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
Beck Depression Inventory-II (BDI-II)	20.00 Scored units on a scale Standard Error 3.94	24.72 Scored units on a scale Standard Error 4.06

PRIMARY outcome

Timeframe: 4-6 hours post-infusion

Although the HAM-D form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2.

Sum the scores from the first 17 items 0-7= Normal 8-13= Mild Depression 14-18= Moderate Depression 19-22= Severe Depression >23= Very Severe Depression

Outcome measures

Measure	Ketamine n=11 Participants IV Ketamine .25mg/kg Ketamine: IV of Ketamine (.25mg/kg)	Diphenhydramine n=10 Participants 25mg Diphenhydramine Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
Hamilton Depression Scale (Ham-D)	21.48 Scored units on a scale Standard Error 2.08	17.00 Scored units on a scale Standard Error 2.26

SECONDARY outcome

Timeframe: Baseline and 16 weeks

The I-TAS is a 10-item, Likert-style rating scale designed to assess a patient's composite treatment alliance as it develops across multi-disciplinary treatment components. The I-TAS was intended to measure the primary alliance factors identified by Hatcher and Barends (1996) of bond, goals and collaboration. Each question is scored on a scale of 0 (Completely False) to 6 (Completely True). Total scores on the ITAS range from 0 to 60, with higher scores representing greater alliance with the treatment team (better outcome). The reported score is an average of each participant's total score on the ITAS.

Outcome measures

Measure	Ketamine n=11 Participants IV Ketamine .25mg/kg Ketamine: IV of Ketamine (.25mg/kg)	Diphenhydramine n=10 Participants 25mg Diphenhydramine Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
Change in Treatment Alliance Score	43.52 Scored units on a scale Standard Error 3.69	53.15 Scored units on a scale Standard Error 4.17

SECONDARY outcome

Timeframe: 40 minutes post-infusion

BDI-II items are rated on a 4-point scale ranging from 0 to 3 based on severity of each item. The maximum total score is 63.

0-13 Indicates minimal depression 14-19 Indicates mild depression 20-28 Indicates Moderate depression 29-63 Indicates Severe depression

Outcome measures

Measure	Ketamine n=11 Participants IV Ketamine .25mg/kg Ketamine: IV of Ketamine (.25mg/kg)	Diphenhydramine n=10 Participants 25mg Diphenhydramine Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
Beck Scale for Suicidal Ideation (BSSI)	1.58 units on a scale Standard Error 1.40	1.08 units on a scale Standard Error 1.42

SECONDARY outcome

Timeframe: 40 minutes post-infusion

40 Minutes Post Infusion, The MADRS-S instrument has nine questions, with an overall score ranging from 0 to 54 points.

0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression.

Outcome measures

Measure	Ketamine n=11 Participants IV Ketamine .25mg/kg Ketamine: IV of Ketamine (.25mg/kg)	Diphenhydramine n=10 Participants 25mg Diphenhydramine Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
Montgomery-Åsberg Depression Rating Scale Suicide Ideation Item (MADRS-SI)	0.83 units on a scale Standard Error 0.46	0.75 units on a scale Standard Error 0.40

SECONDARY outcome

Timeframe: 2 Weeks Post-infusion

Outcome measures

Measure	Ketamine n=11 Participants IV Ketamine .25mg/kg Ketamine: IV of Ketamine (.25mg/kg)	Diphenhydramine n=10 Participants 25mg Diphenhydramine Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
Length of Inpatient Stay	6.33 Days Standard Error 1.32	7.80 Days Standard Error 1.25

SECONDARY outcome

Timeframe: 1 Day

Scoring System: 0= not compliant, 1=compliant

Outcome measures

Measure	Ketamine n=11 Participants IV Ketamine .25mg/kg Ketamine: IV of Ketamine (.25mg/kg)	Diphenhydramine n=10 Participants 25mg Diphenhydramine Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
Outpatient Follow-up Compliance	0.73 units on follow up compliance scale Standard Error .14	.70 units on follow up compliance scale Standard Error .14

SECONDARY outcome

Timeframe: 7 days post-infusion

The I-TAS is a 10-item, Likert-style rating scale designed to assess a patient's composite treatment alliance as it develops across multi-disciplinary treatment components. The I-TAS was intended to measure the primary alliance factors identified by Hatcher and Barends (1996) of bond, goals and collaboration. Each question is scored on a scale of 0 (Completely False) to 6 (Completely True). Total scores on the ITAS range from 0 to 60, with higher scores representing greater alliance with the treatment team (better outcome). The reported score is an average of each participant's total score on the ITAS.

Outcome measures

Measure	Ketamine n=11 Participants IV Ketamine .25mg/kg Ketamine: IV of Ketamine (.25mg/kg)	Diphenhydramine n=10 Participants 25mg Diphenhydramine Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
Inpatient Treatment Alliance Scale (ITAS)	43.52 Scored units on ITAS Scale Standard Error 3.69	53.15 Scored units on ITAS Scale Standard Error 4.17

Adverse Events

Ketamine

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Diphenhydramine

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ketamine n=11 participants at risk IV Ketamine .25mg/kg Ketamine: IV of Ketamine (.25mg/kg)	Diphenhydramine n=10 participants at risk 25mg Diphenhydramine Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
Psychiatric disorders Psychosis and Suicidality	9.1% 1/11 • Number of events 1	0.00% 0/10

Other adverse events

Measure	Ketamine n=11 participants at risk IV Ketamine .25mg/kg Ketamine: IV of Ketamine (.25mg/kg)	Diphenhydramine n=10 participants at risk 25mg Diphenhydramine Diphenhydramine: Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
General disorders Tiredness	9.1% 1/11 • Number of events 1	30.0% 3/10 • Number of events 3
General disorders Perceptual Disturbance	18.2% 2/11 • Number of events 2	20.0% 2/10 • Number of events 2
General disorders Headache	9.1% 1/11 • Number of events 1	0.00% 0/10
General disorders Dizziness	18.2% 2/11 • Number of events 2	10.0% 1/10 • Number of events 1
General disorders Toe Numbness	0.00% 0/11	10.0% 1/10 • Number of events 1
General disorders GI Distress	18.2% 2/11 • Number of events 2	0.00% 0/10
Vascular disorders Elevated Systolic BP	0.00% 0/11	10.0% 1/10 • Number of events 1

Additional Information

Stephen Ross, MD/ Principal Investigator

New York University School of Medicine

Phone: 212 562 4097

Email: Stephen.Ross@nyumc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place