Trial Outcomes & Findings for Ketamine Infusion for Obsessive-Compulsive Disorder (NCT NCT01349231)

Results Overview

We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 1 day following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Baseline and 1 day after ketamine infusion

Results posted on

2014-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Ketamine Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine. ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes).
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ketamine Infusion for Obsessive-Compulsive Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine n=10 Participants Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine. ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes).
Age, Continuous	41.7 years STANDARD_DEVIATION 13.5 • n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	32.9 units on a scale STANDARD_DEVIATION 1.9 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1 day after ketamine infusion

We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 1 day following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.

Outcome measures

Outcome measures
Measure	Ketamine n=10 Participants Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine. ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes).
OCD Severity	-2.7 units on a scale Standard Deviation 1.11

PRIMARY outcome

Timeframe: Baseline and 2 days following infusion

We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 2 days following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.

Outcome measures

Outcome measures
Measure	Ketamine n=10 Participants Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine. ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes).
OCD Severity	-3.6 units on a scale Standard Deviation 1.19

PRIMARY outcome

Timeframe: Baseline and 3 days following infusion

We will examine change from baseline in the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) ratings of OCD severity at 3 days following infusion. The Yale-Brown Obsessive Compulsive Scale (Y-BOCS) assesses obsessive and compulsive symptom severity. Obsessions are rated on a scale from 0-20 and compulsions are rated on a scale of 0-20, for a total scale of 0-40. Scores on the obsessions scale and scores on the compulsions scale are summed to obtain the total score. The higher the score, the more severe the OCD.

Outcome measures

Outcome measures
Measure	Ketamine n=10 Participants Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine. ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes).
OCD Severity	-2.9 units on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: Baseline, Day 1, Day 2, and Day 3

We will examine change from baseline in Hamilton Rating Scale for Depression (HRDS) ratings of depression severity at day 1-3 following a single ketamine infusion. The HRDS assesses severity of, and change in, depressive symptoms. The HRDS is a 21 item scale with scores ranging from 0-66. The higher the score, the more severe the depression.

Outcome measures

Outcome measures
Measure	Ketamine n=10 Participants Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine. ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes).
Depression Symptoms HRDS change from Baseline to Day 1	-6.57 units on a scale Standard Deviation 1.69
Depression Symptoms HRDS change from Baseline to Day 2	-7.29 units on a scale Standard Deviation 2.89
Depression Symptoms HRDS change from Baseline to Day 3	-5.14 units on a scale Standard Deviation 2.48

Adverse Events

Ketamine

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketamine n=10 participants at risk Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine. ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes).
General disorders Transient increase in systolic blood pressure	10.0% 1/10
Psychiatric disorders Dysphoria	20.0% 2/10
Psychiatric disorders Dissociative symptoms	50.0% 5/10
Psychiatric disorders Anxiety	20.0% 2/10
Psychiatric disorders Passive suicidal ideation	20.0% 2/10

Additional Information

Dr. Michael Bloch, MD, MS

Yale University, Connecticut Mental Health Center

Phone: 203-737-4809

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place