Clinical trial NCT01100255: Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD)
Official title: Understanding the Glutamate System in Adults With Obsessive-Compulsive Disorder With N-methyl-D Aspartate Antagonist Ketamine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2010-04-08
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: Columbia-NYSPI-RFMH
name: Carolyn I. Rodriguez, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.