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Brief Intervention for OCD Fears

Primary Purpose

Obsessive-compulsive Disorder

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Propanolol
Placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obsessive-compulsive Disorder focused on measuring propanolol, obsessive-compulsive disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Principal Diagnosis of Obsessive-Compulsive Disorder

Exclusion Criteria:

  • History of other serious psychiatric disorder
  • Current Major Depressive Disorder
  • Women who are pregnant or nursing
  • Current use of psychiatric medication
  • Persons planning to start another treatment during the study period
  • Any significant medical condition that might increase the risk or participation or use of medications that might negatively interact with propranolol

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Propanolol

Placebo capsule

Arm Description

Propranolol 40 mg capsule, given once after fear reactivation procedure

Placebo capsule, given once after fear reactivation procedure

Outcomes

Primary Outcome Measures

Yale Brown Obsessive-Compulsive Scale
Total score on this Clinician-administered measure of OCD symptoms

Secondary Outcome Measures

Behavioral Avoidance Task
Total number of steps completed (0-5) on this task assessing avoidance of OCD triggers

Full Information

First Posted
May 26, 2016
Last Updated
April 12, 2023
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02790710
Brief Title
Brief Intervention for OCD Fears
Official Title
Brief Intervention for OCD Fears
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study has been withdrawn due to reconsideration of study design.
Study Start Date
June 2016 (Actual)
Primary Completion Date
April 2023 (Actual)
Study Completion Date
April 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will test the efficacy of propranolol or placebo, administered after reactivation of a previously acquired obsessive-compulsive disorder (OCD) fear, in reducing fear and avoidance in OCD.
Detailed Description
Twenty subjects with OCD will be enrolled in the study. Participants will complete baseline assessments of fear and avoidance. Participants will be randomly assigned to a single dose of propranolol 40mg or placebo, administered immediately after a fear reactivation procedure. Primary outcome assessment will be OCD symptoms and avoidance behavior in a behavioral avoidance task 2 weeks after the intervention

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-compulsive Disorder
Keywords
propanolol, obsessive-compulsive disorder

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propanolol
Arm Type
Experimental
Arm Description
Propranolol 40 mg capsule, given once after fear reactivation procedure
Arm Title
Placebo capsule
Arm Type
Placebo Comparator
Arm Description
Placebo capsule, given once after fear reactivation procedure
Intervention Type
Drug
Intervention Name(s)
Propanolol
Other Intervention Name(s)
Inderal
Intervention Description
Active treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Primary Outcome Measure Information:
Title
Yale Brown Obsessive-Compulsive Scale
Description
Total score on this Clinician-administered measure of OCD symptoms
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Behavioral Avoidance Task
Description
Total number of steps completed (0-5) on this task assessing avoidance of OCD triggers
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Principal Diagnosis of Obsessive-Compulsive Disorder Exclusion Criteria: History of other serious psychiatric disorder Current Major Depressive Disorder Women who are pregnant or nursing Current use of psychiatric medication Persons planning to start another treatment during the study period Any significant medical condition that might increase the risk or participation or use of medications that might negatively interact with propranolol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blair Simpson, MD
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Study Director
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10028-2611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Brief Intervention for OCD Fears

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