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

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Sponsor:

Information provided by (Responsible Party):

New York State Psychiatric Institute

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator)
Condition	Obsessive-Compulsive Disorder
Interventions	Drug: Ketamine infusion Other: Saline
Enrollment	15

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	Group A	Group B
Arm/Group Description	0.5mg/kg IV ketamine infusion over ...	IV saline infusion over 40 minutes ...
Arm/Group Description	0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes	IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
Period Title: Overall Study
Started	8	7
Completed	8	7
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Group A	Group B	Total
Arm/Group Description		0.5mg/kg IV ketamine infusion over ...	IV saline infusion over 40 minutes ...	Total of all reporting groups
Arm/Group Description		0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes	IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes	Total of all reporting groups
Overall Number of Baseline Participants		8	7	15
Baseline Analysis Population Description		...
Baseline Analysis Population Description		This was a cross over trial.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	8 participants	7 participants	15 participants
		36 (10)	32 (8)	34 (9)
Gender Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	8 participants	7 participants	15 participants
	Female	4 50.0%	3 42.9%	7 46.7%
	Male	4 50.0%	4 57.1%	8 53.3%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	8 participants	7 participants	15 participants
	Hispanic or Latino	2 25.0%	1 14.3%	3 20.0%
	Not Hispanic or Latino	6 75.0%	6 85.7%	12 80.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	8 participants	7 participants	15 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	1 14.3%	1 6.7%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	6 75.0%	3 42.9%	9 60.0%
	White	2 25.0%	3 42.9%	5 33.3%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%

Outcome Measures

1.Primary Outcome


Title	Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.
Description	Patients given YBOCS (Yale Brown Obsessive-Compulsive Scale), a gold s...
Description	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.
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Saline Infusion	Ketamine Infusion
Arm/Group Description:	IV saline infusion over 40 minutes ...	0.5mg/kg IV infusion over 40 minute...
Arm/Group Description:	IV saline infusion over 40 minutes Saline: saline infusion	0.5mg/kg IV infusion over 40 minutes Ketamine infusion: 0.5mg/kg IV over 40 minutes
Overall Number of Participants Analyzed	15	15
Measure Type: Number Unit of Measure: participants
	0	5

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Saline Infusion		Ketamine Infusion
Arm/Group Description	IV saline infusion over 40 minutes		0.5mg/kg IV ketamine infusion over ...
Arm/Group Description	IV saline infusion over 40 minutes		0.5mg/kg IV ketamine infusion over 40 minutes
All-Cause Mortality
	Saline Infusion		Ketamine Infusion
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events Serious Adverse Events
	Saline Infusion		Ketamine Infusion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0.00%)		0/15 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Saline Infusion		Ketamine Infusion
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/15 (0.00%)		4/15 (26.67%)
Gastrointestinal disorders
Nausea ^* [1]	0/15 (0.00%)	0	2/15 (13.33%)	2
Vomiting ^* [2]	0/15 (0.00%)	0	1/15 (6.67%)	1
Nervous system disorders
Dizziness ^* [3]	0/15 (0.00%)	0	3/15 (20.00%)	3
Headache ^* [4]	0/15 (0.00%)	0	2/15 (13.33%)	2
* Indicates events were collected by non-systematic assessment [1] Nausea resolved within 110min of the start of the infusion. [2] Vomiting resolved within 110min of the start of the infusion. [3] Dizziness resolved within 110min of the start of the infusion. [4] Headache resolved within 110min of the start of the infusion.

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	Dr. Carolyn Rodriguez, Assistant Professor
Organization:	Stanford University
Phone:	6507236158
EMail:	carolynrodriguez@stanford.edu

Publications of Results:

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.

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.

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.

Layout table for additonal information

Responsible Party:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT01100255
Other Study ID Numbers:	6906R/5883
First Submitted:	April 5, 2010
First Posted:	April 8, 2010
Results First Submitted:	May 19, 2016
Results First Posted:	October 27, 2016
Last Update Posted:	February 20, 2017

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