Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD)
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Purpose
In this study investigators are studying the effects of a drug called ketamine on the symptoms of Obsessive-compulsive disorder (OCD).
| Condition | Intervention | Phase |
|---|---|---|
|
Obsessive-Compulsive Disorder |
Drug: Ketamine infusion Other: Saline |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) |
| Official Title: | Understanding the Glutamate System in Adults With Obsessive-Compulsive Disorder With N-methyl-D Aspartate Antagonist Ketamine |
- improvement in severity of OCD symptoms as measured by the YBOCS (Yale-Brown Obsessive Compulsive Scale) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: saline infusion
IV saline infusion over 40 minutes
|
Other: Saline
saline infusion
|
|
Experimental: Ketamine Infusion
0.5mg/kg IV infusion over 40 minutes
|
Drug: Ketamine infusion
0.5mg/kg IV over 40 minutes
Other Name: Ketamine hydrochloride
|
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| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Carolyn I. Rodriguez, M.D., Ph.D. | 212-543-5637 | |
| Contact: James Bender, Psy.D. | 212-543-5462 |
| United States, New York | |
| New York State Psychiatric Institute | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Carolyn I. Rodriguez, M.D., Ph.D. 212-543-5637 | |
| Contact: James Bender, Psy.D. 212-543-5462 | |
| Principal Investigator: Carolyn I. Rodriguez, MD., Ph.D. | |
| Principal Investigator: | Carolyn I. Rodriguez, M.D., Ph.D. | Columbia-NYSPI-RFMH |
More Information
No publications provided by New York State Psychiatric Institute
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT01100255 History of Changes |
| Other Study ID Numbers: | 5883 |
| Study First Received: | April 5, 2010 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York State Psychiatric Institute:
|
OCD |
Additional relevant MeSH terms:
|
Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders N-Methylaspartate Ketamine Excitatory Amino Acid Agonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Excitatory Amino Acid Antagonists Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013