Trial Outcomes & Findings for Ketamine Treatment for Pediatric-Refractory Obsessive-Compulsive Disorder (OCD) (NCT NCT02422290)

Last Updated: 2020-08-17

Results Overview

The CY-BOCS is a semi-structured measure of OCD severity with excellent inter-rater reliability, internal consistency, and test-retest reliability. It is validated in those starting at age 7 and used in studies up to age 20. The CYBOCS differs from the adult YBOCS only in its use of simpler language. The CY-BOCS consists of 10 items which are summed up to derive the total CY-BOCS score. The total score ranges from 0-40 with higher scores indicating greater severity of OCD symptoms.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Screening, Baseline, Day 7, Day 17, 3-Month; Baseline and Day 14 pre-specified to be reported

Results posted on

2020-08-17

Participant Flow

Participant milestones

Participant milestones
Measure	Adolescent OCD Ketamine Group Open trial of ketamine IV for adolescents with treatment refractory OCD
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ketamine Treatment for Pediatric-Refractory Obsessive-Compulsive Disorder (OCD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Demographics n=5 Participants Demographics of participants
Age, Continuous	16.6 years STANDARD_DEVIATION 1.52 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 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	0 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	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Screening, Baseline, Day 7, Day 17, 3-Month; Baseline and Day 14 pre-specified to be reported

Outcome measures

Outcome measures
Measure	Ketamine Treatment Group n=5 Participants Adolescents and young adults with OCD who received an intravenous ketamine infusion.
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) CY-BOCS Baseline	29.00 score on a scale Standard Deviation 5.52
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) CY-BOCS Day 14	26.20 score on a scale Standard Deviation 5.59

PRIMARY outcome

Timeframe: Screening, Baseline, Day 7, Day 17, 3-Month; Baseline and Day 14 pre-specified to be reported

The CGI-S is a clinician rated 7-point rating scale for the severity of a participant's illness relative to the clinician's experience of working with this particular population. The score ranges from 1-7 with higher scores indicating greater illness severity.

Outcome measures

Outcome measures
Measure	Ketamine Treatment Group n=5 Participants Adolescents and young adults with OCD who received an intravenous ketamine infusion.
Clinical Global Impressions - Severity Scale (CGI-S) CGI-S Baseline	5.80 score on a scale Standard Deviation 0.45
Clinical Global Impressions - Severity Scale (CGI-S) CGI-S Day 14	5.00 score on a scale Standard Deviation 1.00

SECONDARY outcome

Timeframe: Screening, Baseline, Day 1-14, 3-Month; Baseline and Day 14 pre-specified to be reported

The OCD-VAS is a one-item unipolar scale to assess OCD symptoms over a rapid time frame ("No obsessions" to "Constant obsessions"). The scale ranges from 0-10 with higher scores indicating higher presence of obsessions.

Outcome measures

Outcome measures
Measure	Ketamine Treatment Group n=5 Participants Adolescents and young adults with OCD who received an intravenous ketamine infusion.
OCD Visual Analogue Scale (OCD-VAS) OCD-VAS Baseline	5.00 score on a scale Standard Deviation 1.00
OCD Visual Analogue Scale (OCD-VAS) OCD-VAS Day 14	5.00 score on a scale Standard Deviation 2.12

SECONDARY outcome

Timeframe: Screening, Baseline, Day 1-14, 3-Month; Baseline and Day 14 pre-specified to be reported

Population: One participant was missing data

The Y-BOCCS is self-report scale which assesses OCD symptoms on a 5-point likert scale ("None" to "Extreme"). It consists of 10 items which are summed up to derive the total Y-BOCCS score. The total score ranges from 0-40 with higher scores indicating higher prevalence of OCD symptoms.

Outcome measures

Outcome measures
Measure	Ketamine Treatment Group n=4 Participants Adolescents and young adults with OCD who received an intravenous ketamine infusion.
Yale-Brown Obsessive Compulsive Challenge Scale (Y-BOCCS) Y-BOCCS Baseline	18.25 score on a scale Standard Deviation 7.27
Yale-Brown Obsessive Compulsive Challenge Scale (Y-BOCCS) Y-BOCCS Day 14	16.50 score on a scale Standard Deviation 5.32

Adverse Events

Ketamine Treatment Group

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ketamine Treatment Group n=5 participants at risk Adolescents and young adults with OCD who received an intravenous ketamine infusion.
Psychiatric disorders Psychiatric Hospitalization	20.0% 1/5 • Number of events 1 • Adverse event data was collected during the ketamine infusion and for two hours post-infusion. Following the infusion, adverse events were assessed daily for a period of 14 days and at a 3-month follow-up visit.

Other adverse events

Other adverse events
Measure	Ketamine Treatment Group n=5 participants at risk Adolescents and young adults with OCD who received an intravenous ketamine infusion.
Psychiatric disorders Dissociation	80.0% 4/5 • Number of events 4 • Adverse event data was collected during the ketamine infusion and for two hours post-infusion. Following the infusion, adverse events were assessed daily for a period of 14 days and at a 3-month follow-up visit.
Nervous system disorders Dizziness	40.0% 2/5 • Number of events 2 • Adverse event data was collected during the ketamine infusion and for two hours post-infusion. Following the infusion, adverse events were assessed daily for a period of 14 days and at a 3-month follow-up visit.

Additional Information

Pablo H. Goldberg, MD

New York State Psychiatric Institute

Phone: 646-774-6318

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place