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

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ClinicalTrials.gov Identifier: NCT01100255
Recruitment Status : Completed
First Posted : April 8, 2010
Results First Posted : October 27, 2016
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

April 5, 2010
April 8, 2010
May 19, 2016
October 27, 2016
February 20, 2017
April 2010
December 2015   (Final data collection date for primary outcome measure)
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale. [ Time Frame: 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.
improvement in severity of OCD symptoms as measured by the YBOCS (Yale-Brown Obsessive Compulsive Scale) [ Time Frame: 2 weeks ]
Complete list of historical versions of study NCT01100255 on ClinicalTrials.gov Archive Site
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Not Provided
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Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD)
Understanding the Glutamate System in Adults With Obsessive-Compulsive Disorder With N-methyl-D Aspartate Antagonist Ketamine
In this study investigators are studying the effects of a drug called ketamine on the symptoms of Obsessive-compulsive disorder (OCD).
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Obsessive-Compulsive Disorder
  • Drug: Ketamine infusion
    0.5mg/kg IV over 40 minutes
    Other Name: Ketamine hydrochloride
  • Other: Saline
    saline infusion
  • Active Comparator: Group A
    0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
    Interventions:
    • Drug: Ketamine infusion
    • Other: Saline
  • Active Comparator: Group B
    IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
    Interventions:
    • Drug: Ketamine infusion
    • Other: Saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
10
December 2015
December 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01100255
6906R/5883
Yes
Not Provided
Plan to Share IPD: No
New York State Psychiatric Institute
New York State Psychiatric Institute
Not Provided
Principal Investigator: Carolyn I. Rodriguez, M.D., Ph.D. Columbia-NYSPI-RFMH
New York State Psychiatric Institute
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP