Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD)

NCT ID: NCT01100255

Last Updated: 2017-02-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2015-12-31

Brief Summary

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In this study investigators are studying the effects of a drug called ketamine on the symptoms of Obsessive-compulsive disorder (OCD).

Detailed Description

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Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Recent evidence suggest that a different neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from OCD. In this study the investigators are recruiting patients to receive the drug ketamine, which is thought to modulate the neurotransmitter glutamate through the N-methyl-D-aspartate (NMDA), in a 2-week placebo controlled study.

Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group A

0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes

Group Type ACTIVE_COMPARATOR

Ketamine infusion

Intervention Type DRUG

0.5mg/kg IV over 40 minutes

Saline

Intervention Type OTHER

saline infusion

Group B

IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes

Group Type ACTIVE_COMPARATOR

Ketamine infusion

Intervention Type DRUG

0.5mg/kg IV over 40 minutes

Saline

Intervention Type OTHER

saline infusion

Interventions

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Ketamine infusion

0.5mg/kg IV over 40 minutes

Intervention Type DRUG

Saline

saline infusion

Intervention Type OTHER

Other Intervention Names

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Ketamine hydrochloride

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
* Able to provide consent

Exclusion Criteria

* Psychiatric conditions that make participation unsafe
* Currently on psychotropic medication
* Medical conditions that make participation unsafe
* Allergy to ketamine
* Any metal in the body
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carolyn I. Rodriguez, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Columbia-NYSPI-RFMH

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

References

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Rodriguez CI, Kegeles LS, Flood P, Simpson HB. Rapid resolution of obsessions after an infusion of intravenous ketamine in a patient with treatment-resistant obsessive-compulsive disorder. J Clin Psychiatry. 2011 Apr;72(4):567-9. doi: 10.4088/JCP.10l06653. No abstract available.

Reference Type RESULT
PMID: 21527129 (View on PubMed)

Rodriguez CI, Kegeles LS, Levinson A, Feng T, Marcus SM, Vermes D, Flood P, Simpson HB. Randomized controlled crossover trial of ketamine in obsessive-compulsive disorder: proof-of-concept. Neuropsychopharmacology. 2013 Nov;38(12):2475-83. doi: 10.1038/npp.2013.150. Epub 2013 Jun 19.

Reference Type RESULT
PMID: 23783065 (View on PubMed)

Rodriguez CI, Kegeles LS, Levinson A, Ogden RT, Mao X, Milak MS, Vermes D, Xie S, Hunter L, Flood P, Moore H, Shungu DC, Simpson HB. In vivo effects of ketamine on glutamate-glutamine and gamma-aminobutyric acid in obsessive-compulsive disorder: Proof of concept. Psychiatry Res. 2015 Aug 30;233(2):141-7. doi: 10.1016/j.pscychresns.2015.06.001. Epub 2015 Jun 6.

Reference Type RESULT
PMID: 26104826 (View on PubMed)

Other Identifiers

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6906R/5883

Identifier Type: -

Identifier Source: org_study_id

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