NCT02062658

Brief Summary

This study investigates if a single dose of IV Ketamine can rapidly improve Obsessive-Compulsive Disorder (OCD) symptoms and whether these effect can be maintained with a condensed course of a type of Cognitive Behavioral Therapy called Exposure and Response Prevention (EX/RP). You will be compensated for your time and travel. Participants must be between the ages of 18-55.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 27, 2016

Completed
Last Updated

December 29, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

February 12, 2014

Results QC Date

May 19, 2016

Last Update Submit

November 8, 2016

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale

    Patients given 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 was defined as at least a 35% reduction on the YBOCS.

    2 weeks

Study Arms (1)

Ketamine, Exposure & Response Prevention

EXPERIMENTAL

0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)

Drug: KetamineBehavioral: Exposure and Response Prevention

Interventions

KetamineDRUG

0.5mg/kg IV

Also known as: Ketamine hydrochloride
Ketamine, Exposure & Response Prevention
Exposure and Response PreventionBEHAVIORAL

A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.

Also known as: EX/RP
Ketamine, Exposure & Response Prevention

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-55
  • Physically healthy and not currently pregnant
  • Primary Diagnosis of OCD
  • Sufficient severity of symptoms
  • Currently off all psychotropic medication OR
  • Currently on adequate dose of medication for treatment of OCD, but have not achieved at least partial remission
  • Able to provide consent

You may not qualify if:

  • Psychiatric conditions that make participation unsafe (schizophrenia \[either self or first degree relative e.g. siblings, parents\], history of violence, severe depression, eating disorder, substance dependence \[including nicotine\])
  • Female patients who are either pregnant or nursing
  • Planning to commence EX/RP during the period of the study or those who have completed an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment.
  • period of the study
  • Allergy to ketamine
  • Participants for whom being off of medication is not clinically recommended
  • Medical conditions that make participation unsafe (e.g. high blood pressure, head injury)
  • Currently on medications that make participation unsafe

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Insitute

New York, New York, 10032, United States

Location

Related Publications (1)

  • Rodriguez CI, Wheaton M, Zwerling J, Steinman SA, Sonnenfeld D, Galfalvy H, Simpson HB. Can exposure-based CBT extend the effects of intravenous ketamine in obsessive-compulsive disorder? an open-label trial. J Clin Psychiatry. 2016 Mar;77(3):408-9. doi: 10.4088/JCP.15l10138. No abstract available.

    PMID: 27046314RESULT

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Carolyn Rodriguez, Assistant Professor
Organization
Stanford University
carolynrodriguez@stanford.edu
6507236158

Study Officials

  • H Blair Simpson, MD, PhD

    Columbia-NYSPI-RFMH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 14, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 29, 2016

Results First Posted

October 27, 2016

Record last verified: 2016-11

Locations

US(1)