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OpenTrials
Completed

NCT Number: NCT02062658

Extending Ketamine's Effects in OCD With Exposure and Response Prevention (EX/RP)

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.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New York State Psychiatric Insitute

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

ketamine

Drug

0.5mg/kg IV

Other names: Ketamine hydrochloride

Exposure and Response Prevention

Behavioral

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

Other names: EX/RP

Primary outcomes

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

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Extending Ketamine's Effects in Obsessive-Compulsive Disorder (OCD) With Exposure and Response Prevention (EX/RP)

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 14, 2014
Registry last updated
Dec 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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