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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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Skin conductance response (SCR) is the change in skin conductance level in response to a stimulus. We compared the SCR to a non-treated conditioned stimulus (CS+N) with the SCR to a treated conditioned stimulus (CS+R) by creating a difference score (CS+R - CS+N) for the day 3 data. Day 3 is 48 hours after the fear-conditioning procedure and serves as the primary measure of whether the treatment had an effect. SCR was measured in microSiemens; the SCR difference score reflects a change in microSi
Interventions
- DRUG Intranasal oxytocin
- DRUG Mifepristone
- DRUG Propranolol
- BEHAVIORAL Reactivation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 186 participants |
| Start Date | 2010-11 |
| Est. Completion | 2015-01 |
| Phase | Phase 4 |
What the finished NCT01631682 record still lists
NCT01631682 is an interventional study that assigns participants to a tested intervention. The registered 186 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 4 interventions - of which Intranasal oxytocin is the first listed.
NCT01631682 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01631682's enrollment target sits among peer trials
186 459th of 2000 higher than 1,541 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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