Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Scott Orr, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01631682
First received: June 25, 2012
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Posttraumatic Stress Disorder
Anxiety Disorder
Reconsolidation
Drug: Propranolol
Behavioral: Reactivation
Drug: Mifepristone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Psychophysiology of Delayed Extinction and Reconsolidation in Humans

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change from baseline skin conductance response [ Time Frame: 24hrs ] [ Designated as safety issue: No ]
    Skin conductance response (SCR) is the change in skin conductance in response to a stimulus. We will compare the SCR measurements on day 2 to those acquired during fear conditioning acquisition on day 1.

  • Baseline skin conductance response [ Time Frame: 0hrs ] [ Designated as safety issue: No ]
    Skin conductance response (SCR) is the change in skin conductance in response to a stimulus. We will use these baseline data as a point of comparison at future time points.

  • Change from baseline skin conductance [ Time Frame: 48hrs ] [ Designated as safety issue: No ]
    Skin conductance response (SCR) is the change in skin conductance in response to a stimulus. We will compare the SCR measurements on day 3 to baseline and day 2.

  • Change in skin conductance response [ Time Frame: 30 days (plus or minus 3 days) ] [ Designated as safety issue: No ]
    Skin conductance response (SCR) is the change in skin conductance in response to a stimulus. We will compare the SCR measurements on day 30 to baseline, day 2, and day 3.


Estimated Enrollment: 190
Study Start Date: November 2010
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Propranolol
a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Drug: Propranolol
40mg single pill
Active Comparator: Reactivation with time delay
For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10 minute break and subsequently extinction
Behavioral: Reactivation
subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)
Experimental: Mifepristone
a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
Drug: Mifepristone
Other Names:
  • Mifeprex
  • Korlym

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631682

Contacts
Contact: Scott Orr, Ph.D. (617) 643-7269 scott_orr@hms.harvard.edu
Contact: Jonathan Fricchione, B.S. (617) 643-4780 jfricchione@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Jonathan Fricchione, B.S.    617-643-4780    jfricchione@partners.org   
Principal Investigator: Scott Orr, Ph.D.         
Sub-Investigator: Roger Pitman, M.D.         
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Scott Orr, Associate Professor of Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01631682     History of Changes
Other Study ID Numbers: W81XWH-11-2-0092
Study First Received: June 25, 2012
Last Updated: April 4, 2014
Health Authority: United States: Partners Human Research Committee
United States: Food and Drug Administration
United States: U.S. Army Human Research Protection Office (HRPO)

Keywords provided by Massachusetts General Hospital:
Posttraumatic Stress Disorder
PTSD
Anxiety
Fear of spiders
Reconsolidation
Reconsolidation blockade

Additional relevant MeSH terms:
Anxiety Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Mental Disorders
Propranolol
Mifepristone
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Luteolytic Agents
Menstruation-Inducing Agents
Abortifacient Agents, Steroidal

ClinicalTrials.gov processed this record on July 23, 2014