Brief Intervention for OCD Fears | NCT02790710

Studies
Brief Intervention for OCD Fears

NCT02790710

Sponsor

New York State Psychiatric Institute

Status

Withdrawn

Last Update Posted

Apr 18, 2023Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Obsessive-compulsive Disorder

Interventions

Propanolol
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study has been withdrawn due to reconsideration of study design.

Expanded Access Info

Start Date

Jun 2016Actual

Primary Completion Date

Apr 2023Actual

Completion Date

Apr 2023Actual

First Submitted Date

May 26, 2016

First Submission Date that Met QC Criteria

Jun 3, 2016

First Posted Date

Jun 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2023

Last Update Posted Date

Apr 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Franklin Schneier, Research Scientist, New York State Psychiatric InstitutePrincipal Investigator

Lead Sponsor

New York State Psychiatric InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Propanolol	Experimental	Propranolol 40 mg capsule, given once after fear reactivation procedure	Drug: Propanolol
Placebo capsule	Placebo Comparator	Placebo capsule, given once after fear reactivation procedure	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Propanolol	Drug	Active treatment	Propanolol	Inderal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Yale Brown Obsessive-Compulsive Scale	Total score on this Clinician-administered measure of OCD symptoms	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Behavioral Avoidance Task	Total number of steps completed (0-5) on this task assessing avoidance of OCD triggers	2 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Blair Simpson, MD	New York State Psychiatric Institute	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York State Psychiatric Institute		New York	New York	10028-2611	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009771	Obsessive-Compulsive Disorder

Ancestor Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011433	Propranolol
D000073893	Sugars

Ancestor Terms

ID	Term
D050198	Phenoxypropanolamines
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols

Browse Leaves

Not provided

Browse Branches

Not provided