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A Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02234011
Recruitment Status : Terminated (Terminated due to difficulty in recruiting participants.)
First Posted : September 9, 2014
Results First Posted : May 12, 2017
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Brian P. Brennan, MD, Mclean Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Obsessive-Compulsive Disorder
Interventions Drug: Ketamine
Drug: Placebo
Enrollment 1
Recruitment Details  
Pre-assignment Details One subject completed the screening visit, but chose to withdraw from study due to time commitment required. Because this subject only completed a screening visit, she was never entered into the treatment arm of the study (which begins at the baseline visit).
Arm/Group Title Treatment
Hide Arm/Group Description No participants enrolled in treatment portion of study.
Period Title: Overall Study
Started 0
Completed 0
Not Completed 0
Arm/Group Title Treatment
Hide Arm/Group Description No participants enrolled in treatment portion of study, and therefore never completed a baseline visit. One subject completed a screening visit and then withdrew from study due to time commitments.
Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Number Analyzed 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants
Female
Male
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants
1.Primary Outcome
Title Observing if Ketamine May Cause a Decrease in OCD Symptoms
Hide Description

Examining if ketamine is associated with a decrease in OCD symptoms as measured by the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) at completion of one treatment when compared to placebo (saline solution).

The Y-BOCS measures OCD symptoms on a scale of 0-40, with higher numbers indicating greater severity of OCD symptoms. For this study, subjects had to have a Y-BOCS of greater than or equal to 18 in order to participate.

Time Frame Baseline to Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
One subject had a screening visit, but was never enrolled in the treatment portion and therefore never had any sort of treatment analysis performed on her data.
Arm/Group Title Treatment
Hide Arm/Group Description:
No participants enrolled in treatment portion of study.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment
Hide Arm/Group Description

No participants enrolled in treatment portion of study. One subject had a screening visit, but since she never entered the treatment portion of the study and never received the study medication. Because she never had any exposure to the study medication and had no visits other than the initial screening visit, she was never at risk for any adverse events related to study medication.

No adverse events related to study medication were collected since no subjects ever entered the treatment phase of this study.

All-Cause Mortality
Treatment
Affected / at Risk (%)
Total   0/0 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment
Affected / at Risk (%)
Total   0/0 
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
Name/Title: Dr. Brian Brennan, MD
Organization: McLean Hospital, Biological Psychiatry Laboratory
Phone: 617-855-2911
Responsible Party: Brian P. Brennan, MD, Mclean Hospital
ClinicalTrials.gov Identifier: NCT02234011     History of Changes
Other Study ID Numbers: 2014P001140
First Submitted: September 4, 2014
First Posted: September 9, 2014
Results First Submitted: January 20, 2017
Results First Posted: May 12, 2017
Last Update Posted: May 12, 2017