This pilot study is proposed to determine the acceptability, feasibility and potential efficacy of ketamine, a medication that modulates glutamate in the brain, as a rapid treatment for obsessive-compulsive disorder (OCD) symptoms in adolescents and young adults with OCD. This study will recruit 6 youth (ages 14-22) who are diagnosed with clinically significant OCD and have failed at least one adequate trial of a Serotonin Reuptake Inhibitor (SRI) medication and a course of Cognitive-Behavioral Therapy (CBT) (unless unable to access or tolerate) for OCD in the past. Participants will receive a single infusion of intravenous ketamine and be assessed at regular intervals post-infusion for up to 14 days. At the end of the 14-day treatment phase, all participants will be offered three months of open treatment for OCD with medication and/or CBT.
See Brief Summary for description.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Single infusion of IV Ketamine, 0.5mg/kg
New York State Psychiatric Institute/Columbia University
New York, New York, United States
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
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.
Time frame: Screening, Baseline, Day 7, Day 17, 3-Month; Baseline and Day 14 pre-specified to be reported
Clinical Global Impressions - Severity Scale (CGI-S)
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.
Time frame: Screening, Baseline, Day 7, Day 17, 3-Month; Baseline and Day 14 pre-specified to be reported
OCD Visual Analogue Scale (OCD-VAS)
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.
Time frame: Screening, Baseline, Day 1-14, 3-Month; Baseline and Day 14 pre-specified to be reported
Yale-Brown Obsessive Compulsive Challenge Scale (Y-BOCCS)
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.
Time frame: Screening, Baseline, Day 1-14, 3-Month; Baseline and Day 14 pre-specified to be reported
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