Trial Outcomes & Findings for Intranasal Ketamine in Treatment-Resistant Depression (NCT NCT01304147)

Last Updated: 2017-02-08

Results Overview

Number of patients meeting response criteria of \>=50% decrease in MADRS score from baseline , ie, difference in depressive symptoms using MADRS instrument, 24 hours following drug administration 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms. Each of the 10 items is rated on a scale of 0 to 6, with differing descriptors for each item. These individual item scores are added together to form a total score, which can range between 0 and 60 points.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

24 hours

Results posted on

2017-02-08

Participant Flow

Study participants were recruited from physician referrals, media advertisements, and an academic outpatient psychiatric clinic. All study treatments were performed at Mount Sinai Medical Center between April 2012 and June 2013.

Participant milestones

Participant milestones
Measure	Placebo, Then Ketamine placebo: Single dose of saline (0.9% saline solution) intranasal for 7 days in first intervention, then Ketamine 50mg in second intervention.	Ketamine Then Placebo Ketamine: A single dose of intranasal ketamine up to 50 mg for 7 days in first intervention. Then Placebo for 7 days in 2nd intervention.
First Intervention (7days) STARTED	10	10
First Intervention (7days) COMPLETED	10	10
First Intervention (7days) NOT COMPLETED	0	0
Washout (1 Day) STARTED	10	10
Washout (1 Day) COMPLETED	10	10
Washout (1 Day) NOT COMPLETED	0	0
Second Intervention (7days) STARTED	10	10
Second Intervention (7days) COMPLETED	9	9
Second Intervention (7days) NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo, Then Ketamine placebo: Single dose of saline (0.9% saline solution) intranasal for 7 days in first intervention, then Ketamine 50mg in second intervention.	Ketamine Then Placebo Ketamine: A single dose of intranasal ketamine up to 50 mg for 7 days in first intervention. Then Placebo for 7 days in 2nd intervention.
Second Intervention (7days) Withdrawal by Subject	1	1

Baseline Characteristics

Intranasal Ketamine in Treatment-Resistant Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Participants Treated n=20 Participants
Age, Continuous	48.0 years STANDARD_DEVIATION 12.8 • n=5 Participants
Gender Female	10 Participants n=5 Participants
Gender Male	10 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	0 Participants n=5 Participants
Race (NIH/OMB) White	18 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
Married yes	6 participants n=5 Participants
Married no	14 participants n=5 Participants
Employed yes	10 participants n=5 Participants
Employed no	10 participants n=5 Participants
Age of Onset	21.4 years STANDARD_DEVIATION 12.0 • n=5 Participants
Illness Duration in Years	27.4 years STANDARD_DEVIATION 13.7 • n=5 Participants
Chronic yes	9 participants n=5 Participants
Chronic no	11 participants n=5 Participants
Recurrent yes	17 participants n=5 Participants
Recurrent no	3 participants n=5 Participants
Length of Current Episode in Years	15.2 years STANDARD_DEVIATION 17.4 • n=5 Participants
Failed Antidepressants Medications	4.1 number of medications STANDARD_DEVIATION 3.9 • n=5 Participants
History of Electroconvulsive Therapy yes	4 participants n=5 Participants
History of Electroconvulsive Therapy no	16 participants n=5 Participants
History of Psychotherapy yes	17 participants n=5 Participants
History of Psychotherapy no	2 participants n=5 Participants
History of Psychotherapy missing information	1 participants n=5 Participants
History of Suicide Attempts yes	2 participants n=5 Participants
History of Suicide Attempts no	18 participants n=5 Participants
Past Substance Use Disorder yes	3 participants n=5 Participants
Past Substance Use Disorder no	17 participants n=5 Participants
Current Anxiety Disorder yes	4 participants n=5 Participants
Current Anxiety Disorder no	16 participants n=5 Participants
Melancholic yes	9 participants n=5 Participants
Melancholic no	11 participants n=5 Participants
Atypical yes	2 participants n=5 Participants
Atypical no	18 participants n=5 Participants
Baseline Inventory of Depressive Symptoms- Clinician Rated (Screen)	42.7 units on a scale STANDARD_DEVIATION 8.5 • n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Population: 20 patients randomized and 18 completed both treatment periods

Outcome measures

Outcome measures
Measure	Ketamine n=18 Participants Ketamine: A single dose of intranasal ketamine up to 50 mg	Placebo n=18 Participants placebo: Single dose of saline intranasal
Montgomery-Asberg Depression Rating Scale (MADRS)	8 participants	1 participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Number of events, more detailed in adverse event section

This is a self-report measure for systematically assessing 48 possible adverse events. It documents their severity, relationship to study drug, and the action taken.

Outcome measures

Outcome measures
Measure	Ketamine n=19 Participants Ketamine: A single dose of intranasal ketamine up to 50 mg	Placebo n=19 Participants placebo: Single dose of saline intranasal
Systematic Assessment for Treatment Emergent Effects (SAFTEE)	79 events	57 events

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Dr. James W. Murrough

Icahn School of Medicine at Mount Sinai

Phone: 212-241-7574

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ketamine n=19 participants at risk	Placebo n=19 participants at risk
General disorders Abnormal sensations	10.5% 2/19 • Number of events 2 • within 24 hours following treatment No serious adverse events occurred during the study.	0.00% 0/19 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Weakness or fatigue	31.6% 6/19 • Number of events 6 • within 24 hours following treatment No serious adverse events occurred during the study.	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Feeling strange or unreal	42.1% 8/19 • Number of events 8 • within 24 hours following treatment No serious adverse events occurred during the study.	0.00% 0/19 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Poor Memory	36.8% 7/19 • Number of events 7 • within 24 hours following treatment No serious adverse events occurred during the study.	10.5% 2/19 • Number of events 2 • within 24 hours following treatment No serious adverse events occurred during the study.
Social circumstances Delayed or absent orgasm	26.3% 5/19 • Number of events 5 • within 24 hours following treatment No serious adverse events occurred during the study.	0.00% 0/19 • within 24 hours following treatment No serious adverse events occurred during the study.
Social circumstances Loss of sexual interest	21.1% 4/19 • Number of events 4 • within 24 hours following treatment No serious adverse events occurred during the study.	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Trouble concentrating	21.1% 4/19 • Number of events 4 • within 24 hours following treatment No serious adverse events occurred during the study.	10.5% 2/19 • Number of events 2 • within 24 hours following treatment No serious adverse events occurred during the study.
Social circumstances Problems with sexual arousal	21.1% 4/19 • Number of events 4 • within 24 hours following treatment No serious adverse events occurred during the study.	15.8% 3/19 • Number of events 3 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Dizziness or fainting	15.8% 3/19 • Number of events 3 • within 24 hours following treatment No serious adverse events occurred during the study.	0.00% 0/19 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Dizziness when you stand up	15.8% 3/19 • Number of events 3 • within 24 hours following treatment No serious adverse events occurred during the study.	10.5% 2/19 • Number of events 2 • within 24 hours following treatment No serious adverse events occurred during the study.
Psychiatric disorders Diminished mental	15.8% 3/19 • Number of events 3 • within 24 hours following treatment No serious adverse events occurred during the study.	15.8% 3/19 • Number of events 3 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Feeling drowsy or sleepy	15.8% 3/19 • Number of events 3 • within 24 hours following treatment No serious adverse events occurred during the study.	21.1% 4/19 • Number of events 4 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Poor coordination or unsteadiness	15.8% 3/19 • Number of events 3 • within 24 hours following treatment No serious adverse events occurred during the study.	0.00% 0/19 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Difficulties finding words	15.8% 3/19 • Number of events 3 • within 24 hours following treatment No serious adverse events occurred during the study.	10.5% 2/19 • Number of events 2 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Numbness or tingling	10.5% 2/19 • Number of events 2 • within 24 hours following treatment No serious adverse events occurred during the study.	0.00% 0/19 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Strange taste in mouth	10.5% 2/19 • Number of events 2 • within 24 hours following treatment No serious adverse events occurred during the study.	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Nightmares or other sleep disturbance	10.5% 2/19 • Number of events 2 • within 24 hours following treatment No serious adverse events occurred during the study.	26.3% 5/19 • Number of events 5 • within 24 hours following treatment No serious adverse events occurred during the study.
Eye disorders Blurred vision	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.	0.00% 0/19 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Appetite decreased	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.	0.00% 0/19 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Dry mouth	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Heartbeat rapid or pounding	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Clenching of teeth at night	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Stuffy nose	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.	10.5% 2/19 • Number of events 2 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Irritable	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.	0.00% 0/19 • within 24 hours following treatment No serious adverse events occurred during the study.
Nervous system disorders Headache	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Tremor or shakiness	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.
Gastrointestinal disorders Constipation	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Trouble sitting still	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Feeling nervous or hyper	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.	10.5% 2/19 • Number of events 2 • within 24 hours following treatment No serious adverse events occurred during the study.
Renal and urinary disorders Frequent need to urinate	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.	10.5% 2/19 • Number of events 2 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Apathy/Emotional indifference	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.	10.5% 2/19 • Number of events 2 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Trouble sleeping	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.	47.4% 9/19 • Number of events 9 • within 24 hours following treatment No serious adverse events occurred during the study.
Musculoskeletal and connective tissue disorders Muscle twitching or movements	0.00% 0/19 • within 24 hours following treatment No serious adverse events occurred during the study.	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.
Gastrointestinal disorders Stomach or abdominal discomfort	0.00% 0/19 • within 24 hours following treatment No serious adverse events occurred during the study.	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.
Gastrointestinal disorders Appetite increased	0.00% 0/19 • within 24 hours following treatment No serious adverse events occurred during the study.	5.3% 1/19 • Number of events 1 • within 24 hours following treatment No serious adverse events occurred during the study.
Ear and labyrinth disorders Ringing in ears or trouble hearing	0.00% 0/19 • within 24 hours following treatment No serious adverse events occurred during the study.	10.5% 2/19 • Number of events 2 • within 24 hours following treatment No serious adverse events occurred during the study.
General disorders Unable to sit still	0.00% 0/19 • within 24 hours following treatment No serious adverse events occurred during the study.	10.5% 2/19 • Number of events 2 • within 24 hours following treatment No serious adverse events occurred during the study.