NCT02790710

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2016

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

6.8 years

First QC Date

May 26, 2016

Last Update Submit

April 12, 2023

Conditions

Obsessive-compulsive Disorder

Keywords

propanololobsessive-compulsive disorder

Outcome Measures

Primary Outcomes (1)

  • Yale Brown Obsessive-Compulsive Scale

    Total score on this Clinician-administered measure of OCD symptoms

    2 weeks

Secondary Outcomes (1)

  • Behavioral Avoidance Task

    2 weeks

Study Arms (2)

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

PropanololDRUG

Active treatment

Also known as: Inderal
Propanolol
PlaceboDRUG
Also known as: sugar pill
Placebo capsule

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Principal Diagnosis of Obsessive-Compulsive Disorder

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10028-2611, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

PropranololSugars

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsCarbohydrates

Study Officials

  • Blair Simpson, MD

    New York State Psychiatric Institute

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 6, 2016

Study Start

June 1, 2016

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)