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NCT01631682 · ClinicalTrials.gov registry record · Phase 4

Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders

A Phase 4 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Phase 4
Development phase
186
Enrollment target

NCT01631682: Completed Phase 4 study, sponsored by Massachusetts General Hospital.

NCT01631682 is a Phase 4 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 186 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01631682, a Phase 4 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Phase 4
Development phase
186 participants
Enrollment target

Study Summary

The aim of this project is to create fear conditioning paradigm within which the relative strengths of various novel pharmacological and behavioral interventions can be tested. These interventions are intended to reduce the fearfulness associated with fear conditioning by blocking a memory process known as reconsolidation. In fear conditioning, a "conditioned" stimulus (CS) is paired with an aversive "unconditioned" stimulus (US) such as an electric shock, until presentation of the CS alone comes to elicit a fear conditioned response (CR). The investigators hypothesize that by using a more highly prepared CS (i.e. video of spiders); more sensitive subjects (individuals with stronger acquired CRs); and additional experimental probes for the presence of the latent CR, the investigators may develop a normal human paradigm that is not plagued by previously observed floor effects (i.e. intervention is 100% effective), within which both the established techniques of propranolol and delayed extinction will produce significant, but only partial, CR reduction. This would leave room to test and compare potentially more powerful candidate reconsolidation-blocking or memory-updating interventions. To achieve these aims, subjects will undergo a four-day fear conditioning and delayed extinction protocol. Skin conductance response data will be gathered across the different phases of the experiment.

Interventions

  • DRUG Intranasal oxytocin
  • DRUG Mifepristone
  • DRUG Propranolol
  • BEHAVIORAL Reactivation

Trial Details

FieldValue
Enrollment Target 186 participants
Start Date 2010-11
Est. Completion 2015-01
Phase Phase 4

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT01631682

The ClinicalTrials.gov registry entry for NCT01631682 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 186 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Intranasal oxytocin is the first listed.

NCT01631682 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01631682 about?

NCT01631682 is a clinical study titled "Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders". The aim of this project is to create fear conditioning paradigm within which the relative strengths of various novel pharmacological and behavioral interventions can be tested. These interventions are intended to reduce the fearfulness associated with fear conditioning by blocking a memory process k...

What is the current status of trial NCT01631682?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 186 participants. The study started on 2010-11. Estimated completion is 2015-01.

What interventions are being tested in trial NCT01631682?

The interventions under investigation include: Intranasal oxytocin (DRUG), Mifepristone (DRUG), Propranolol (DRUG), Reactivation (BEHAVIORAL).

Who is sponsoring clinical trial NCT01631682?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.