NCT02206776

Brief Summary

Obsessive-compulsive disorder (OCD) is a common illness that causes significant distress and impairment. Currently, serotonin reuptake inhibitors (SRIs) are the only medications that are FDA-approved to treat OCD. Unfortunately, SRIs can take a long time to work (2-3 months), and even then they usually only partially reduce OCD symptoms. The present study, will test if intranasal ketamine is feasible to use and can reduce OCD symptoms significantly more than a comparison medication called midazolam. Therefore, you may or may not receive ketamine as part of this study. Results from this study will allow doctors and researchers to better understand if you and others with OCD may respond to this class of medications.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

July 31, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

February 23, 2017

Completed
Last Updated

May 3, 2017

Status Verified

March 1, 2017

Enrollment Period

8 months

First QC Date

July 31, 2014

Results QC Date

January 3, 2017

Last Update Submit

March 30, 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.

    Baseline and 1 Week

Study Arms (2)

Midazolam

PLACEBO COMPARATOR

A single dose of intranasal midazolam up to 4 mg

Drug: Intranasal Midazolam

Ketamine

EXPERIMENTAL

A single dose of intranasal ketamine up to 50 mg

Drug: Intranasal Ketamine

Interventions

Intranasal KetamineDRUG

A single dose of intranasal ketamine up to 50 mg

Also known as: Ketamine Hydrochloride
Ketamine
Intranasal MidazolamDRUG

A single dose of intranasal Midazolam up to 4 mg

Midazolam

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
  • For all patients on medications, medications dose must be stable for at least 6 weeks prior to enrollment. Must discuss with Dr. current medications and doses.
  • Able to provide consent

You may not qualify if:

  • First degree relative with schizophrenia
  • Psychiatric conditions that would make participation unsafe determined by study doctor
  • Female patients who are either pregnant or nursing
  • Planning to start EX/RP during the period of the study or those who have completed an adequate dose of EX/RP (defined as 8 or more sessions within 2 months) within 8 weeks prior to enrollment.
  • Nasal obstruction or history of nasal surgery
  • Currently on psychotropic medication or other medication likely to interact with the glutamate system
  • Medical conditions that make participation unsafe
  • Allergy or intolerance to ketamine or midazolam

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 Links

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Dr. Carolyn Rodriguez, Assistant Professor
Organization
Stanford University
ocdresearch@stanford.edu
650-723-4095

Study Officials

  • Carolyn I Rodriguez, M.D., Ph.D.

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2014

First Posted

August 1, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

May 3, 2017

Results First Posted

February 23, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)