Obsessive-compulsive DisorderPhase 4NCT02790710
Brief Intervention for OCD Fears
A Phase 4 study testing Propanolol in people with Obsessive-compulsive Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obsessive-compulsive Disorder
- What is being tested?
- Propanolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Principal Diagnosis of Obsessive-Compulsive Disorder
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10028-2611
About this study
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.
Read the 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
- Conditions
- Obsessive-compulsive Disorder
- Being tested
- Propanolol, Placebo
- Keywords
- propanolol, obsessive-compulsive disorder
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropanololDrug
Also called Inderal
Active treatment
PlaceboDrug
Also called sugar pill
| Study group | Role | What they receive |
|---|---|---|
| Propanolol | Experimental | Propranolol 40 mg capsule, given once after fear reactivation procedure Receives: Drug: Propanolol |
| Placebo capsule | Placebo comparator | Placebo capsule, given once after fear reactivation procedure Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive-Compulsive Scale
Total score on this Clinician-administered measure of OCD symptoms
Measured: 2 weeks
Secondary outcomes (1)
Behavioral Avoidance Task
Total number of steps completed (0-5) on this task assessing avoidance of OCD triggers
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2023
- Study completionApr 2023
Why it stopped: Study has been withdrawn due to reconsideration of study design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive-compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franklin Schneier, New York State Psychiatric Institute
- Investigators
- Blair Simpson, MD, Study director, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790710
- Sponsor's protocol ID
- 7293 (OCD)
- Status last verified
- Apr 2023
- First submitted
- 26 May 2016
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention for OCD Fears
- ClinicalTrials.gov ID
- NCT02790710
- Acronym / sponsor ID
- 7293 (OCD)
- Conditions
- Obsessive-compulsive Disorder
- Keywords
- propanolol, obsessive-compulsive disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study has been withdrawn due to reconsideration of study design.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2023 (actual)
- Study completion
- Apr 2023 (actual)
- First posted
- 6 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propanolol | Experimental | Drug: PropanololPropranolol 40 mg capsule, given once after fear reactivation procedure |
| Placebo capsule | Placebo comparator | Drug: PlaceboPlacebo capsule, given once after fear reactivation procedure |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Principal Diagnosis of Obsessive-Compulsive Disorder
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropanololAlso: InderalActive treatment | Drug | Propanolol |
| PlaceboAlso: sugar pill | Drug | Placebo capsule |
Primary outcome
Yale Brown Obsessive-Compulsive Scale
Time frame: 2 weeks
Total score on this Clinician-administered measure of OCD symptoms
1 secondary outcome
Behavioral Avoidance Task
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blair Simpson, MD study director
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Propanolol in people with Obsessive-compulsive Disorder, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Brown Obsessive-Compulsive Scale (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023; AzTrials last refreshed its copy on 28 Oct 2026.