Trial Outcomes & Findings for A Trial of Intranasal Ketamine for the Treatment of Obsessive-Compulsive Disorder (NCT NCT02234011)

NCT ID: NCT02234011

Last Updated: 2017-05-12

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Baseline to Week 5

Results posted on

2017-05-12

Participant Flow

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).

Participant milestones

Participant milestones
Measure
Treatment
No participants enrolled in treatment portion of study.
Overall Study
STARTED
0
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: Baseline to Week 5

Population: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brian Brennan, MD

McLean Hospital, Biological Psychiatry Laboratory

Phone: 617-855-2911

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place