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

NCT ID: NCT02062658

Last Updated: 2016-12-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obsessive-Compulsive Disorder

Keywords

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OCD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ketamine, Exposure & Response Prevention

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

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

0.5mg/kg IV

Exposure and Response Prevention

Intervention Type BEHAVIORAL

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

Interventions

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Ketamine

0.5mg/kg IV

Intervention Type DRUG

Exposure and Response Prevention

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Ketamine hydrochloride EX/RP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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H Blair Simpson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Columbia-NYSPI-RFMH

Locations

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New York State Psychiatric Insitute

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 27046314 (View on PubMed)

Other Identifiers

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K23MH092434

Identifier Type: NIH

Identifier Source: secondary_id

View Link

#6811

Identifier Type: -

Identifier Source: org_study_id