Phase 4
N=172
Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders
Posttraumatic Stress Disorder · Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01631682 ↗Enrolled (actual)
172
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Change From Baseline Skin Conductance Response — .06; .17; -1.27; -.04 microSiemens — p=>.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Propranolol (Drug); Reactivation (Behavioral); Mifepristone (Drug); Intranasal oxytocin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Skin Conductance Response |
.06; .17; -1.27; -.04 | >.05 |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18-35
- Top half of the normal human distribution of the Spider Phobia Questionnaire-15
Exclusion Criteria:'
- Any criteria for diagnosable spider phobia
- Any current Axis I mental disorder on the Structured Clinical Interview for DSM-IV (SCID)
- Presence of drugs of abuse (e.g. opiates, marijuana, cocaine, or amphetamines) per urine screen
- Non-English speaking (due to lack of validated questionnaires/instruments in other languages)
Data sourced from ClinicalTrials.gov (NCT01631682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.