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

Phase 2

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Drug: Ketamine infusion; Other: Saline

• Registration Number: NCT01100255
• Lead Sponsor: New York State Psychiatric Institute

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-05
• Study First Submitted QC: 2010-04-07
• Study First Posted: 2010-04-08
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2016-05-19
• Results First Submitted QC: 2016-09-06
• Results First Posted: 2016-10-27
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-03
• Last Update Posted: 2017-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	Saline	IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
Group A	Ketamine infusion	0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
Group A	Saline	0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
Group B	Ketamine infusion	IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes

Primary Outcome Measures

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

Trial Locations

Locations (1)

New York State Psychiatric Institute; 🇺🇸 New York, New York, United States