- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02790710
Brief Intervention for OCD Fears
April 12, 2023 updated by: Franklin Schneier, New York State Psychiatric Institute
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10028-2611
- New York State Psychiatric Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 58 years (Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Propanolol
Propranolol 40 mg capsule, given once after fear reactivation procedure
|
Active treatment
Other Names:
|
Placebo Comparator: Placebo capsule
Placebo capsule, given once after fear reactivation procedure
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Yale Brown Obsessive-Compulsive Scale
Time Frame: 2 weeks
|
Total score on this Clinician-administered measure of OCD symptoms
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral Avoidance Task
Time Frame: 2 weeks
|
Total number of steps completed (0-5) on this task assessing avoidance of OCD triggers
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Blair Simpson, MD, New York State Psychiatric Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
April 1, 2023
Study Completion (Actual)
April 1, 2023
Study Registration Dates
First Submitted
May 26, 2016
First Submitted That Met QC Criteria
June 3, 2016
First Posted (Estimate)
June 6, 2016
Study Record Updates
Last Update Posted (Actual)
April 18, 2023
Last Update Submitted That Met QC Criteria
April 12, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Personality Disorders
- Anxiety Disorders
- Compulsive Personality Disorder
- Obsessive-Compulsive Disorder
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Propranolol
Other Study ID Numbers
- 7293 (OCD)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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