NCT02624596

Brief Summary

The purpose of this study is to understand how ketamine brings about rapid improvement in Obsessive-Compulsive Disorder (OCD) symptoms.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
1mo left

Started Jun 2016

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 8, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

10 years

First QC Date

December 2, 2015

Last Update Submit

May 27, 2025

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD

Outcome Measures

Primary Outcomes (1)

  • improvement in the severity of OCD symptoms as measured by the Yale-Brown Obsessive Compulsive Scale (YBOCS)

    Improvement in OCD severity is measured by the YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold standard measure of obsessions and compulsions. For the YBOCS the minimum units are 0 and Maximum units on the total scale are 40. The higher the number on the YBOCS, the more severe the symptoms. Response is defined as at least a 35% reduction on the YBOCS.

    Up to 6 months

Secondary Outcomes (1)

  • Regional gamma-aminobutyric acid, glutamate/glutamine levels derived from 3T Magnetic Resonance Spectroscopy

    up to 90 minutes

Study Arms (2)

Ketamine

EXPERIMENTAL

OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion

Drug: Ketamine

Midazolam

ACTIVE COMPARATOR

OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion

Drug: Midazolam

Interventions

KetamineDRUG

OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion

Also known as: Ketamine Hydrochloride
Ketamine
MidazolamDRUG

OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion

Also known as: Midazolam Hydrochloride
Midazolam

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18-65
  • Primary diagnosis of OCD
  • Sufficient severity of OCD symptoms
  • ability to tolerate a treatment-free period
  • capacity to provide informed consent
  • ages 18-65
  • capacity to provide informed consent

You may not qualify if:

  • Psychiatric or medical conditions that make participation unsafe
  • pregnant or nursing females
  • concurrent use of any medications that might increase the risk of participation (e.g. drug interactions)
  • presence of metallic device or dental braces
  • any current or lifetime psychiatric diagnosis
  • pregnant or nursing females
  • major medical or neurological problem
  • presence of metallic device or dental braces

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

  • Bandeira ID, Lins-Silva DH, Cavenaghi VB, Dorea-Bandeira I, Faria-Guimaraes D, Barouh JL, Jesus-Nunes AP, Beanes G, Souza LS, Leal GC, Sanacora G, Miguel EC, Sampaio AS, Quarantini LC. Ketamine in the Treatment of Obsessive-Compulsive Disorder: A Systematic Review. Harv Rev Psychiatry. 2022 Mar-Apr 01;30(2):135-145. doi: 10.1097/HRP.0000000000000330.

    PMID: 35267254DERIVED

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

KetamineMidazolam

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Carolyn I Rodriguez, MD, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 8, 2015

Study Start

June 1, 2016

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 31, 2025

Record last verified: 2025-05

Locations

US(1)