Trial Outcomes & Findings for Extending Ketamine's Effects in OCD With Exposure and Response Prevention (EX/RP) (NCT NCT02062658)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

2 weeks

Results posted on

2016-12-29

Participant Flow

Adult outpatients were recruited from the community starting March 2014 until March 2015.

No pre-assignment was done.

Participant milestones

Participant milestones
Measure	Ketamine, Exposure & Response Prevention 0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP) Ketamine: 0.5mg/kg IV Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketamine, Exposure & Response Prevention 0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP) Ketamine: 0.5mg/kg IV Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.
Overall Study Withdrawal by Subject	1
Overall Study Lack of Efficacy	1

Baseline Characteristics

Extending Ketamine's Effects in OCD With Exposure and Response Prevention (EX/RP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine, Exposure & Response Prevention n=10 Participants 0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP) Ketamine: 0.5mg/kg IV Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	35.3 years STANDARD_DEVIATION 10.6 • n=93 Participants
Gender Female	1 Participants n=93 Participants
Gender Male	9 Participants n=93 Participants

PRIMARY outcome

Timeframe: 2 weeks

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.

Outcome measures

Outcome measures
Measure	Ketamine, Exposure & Response Prevention n=8 Participants 0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP) Ketamine: 0.5mg/kg IV Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.
Number of Patients Who Met and Exceeded Response Criteria of Yale-Brown Obsessive-Compulsive Scale	5 participants

Adverse Events

Ketamine, Exposure & Response Prevention

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. Carolyn Rodriguez, Assistant Professor

Stanford University

Phone: 6507236158

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place