NCT01100255

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2010

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 27, 2016

Completed
Last Updated

February 20, 2017

Status Verified

January 1, 2017

Enrollment Period

5.7 years

First QC Date

April 5, 2010

Results QC Date

May 19, 2016

Last Update Submit

January 3, 2017

Conditions

Obsessive-Compulsive Disorder

Keywords

OCD

Outcome Measures

Primary Outcomes (1)

  • Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale.

    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.

    1 week

Study Arms (2)

Group A

ACTIVE COMPARATOR

0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes

Drug: Ketamine infusionOther: Saline

Group B

ACTIVE COMPARATOR

IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes

Drug: Ketamine infusionOther: Saline

Interventions

Ketamine infusionDRUG

0.5mg/kg IV over 40 minutes

Also known as: Ketamine hydrochloride
Group AGroup B
SalineOTHER

saline infusion

Group AGroup B

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-55
  • Physically healthy and not currently pregnant
  • Primary Diagnosis of OCD
  • Sufficient severity of symptoms
  • Able to provide consent

You may not qualify if:

  • Psychiatric conditions that make participation unsafe
  • Currently on psychotropic medication
  • Medical conditions that make participation unsafe
  • Allergy to ketamine
  • Any metal in the body

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (3)

  • 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.

    PMID: 21527129RESULT

  • 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.

    PMID: 23783065RESULT

  • 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.

    PMID: 26104826RESULT

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

KetamineSodium Chloride

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Results Point of Contact

Title
Dr. Carolyn Rodriguez, Assistant Professor
Organization
Stanford University
carolynrodriguez@stanford.edu
6507236158

Study Officials

  • Carolyn I. Rodriguez, M.D., Ph.D.

    Columbia-NYSPI-RFMH

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2010

First Posted

April 8, 2010

Study Start

April 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 20, 2017

Results First Posted

October 27, 2016

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)