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Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01631682
First Posted: June 29, 2012
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Scott Orr, Massachusetts General Hospital
  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 Drug: Propranolol Behavioral: Reactivation Drug: Mifepristone Drug: Intranasal oxytocin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Psychophysiology of Delayed Extinction and Reconsolidation in Humans

Resource links provided by NLM:


Further study details as provided by Scott Orr, Massachusetts General Hospital:

Primary Outcome Measures:
  • Change From Baseline Skin Conductance Response [ Time Frame: 48hrs ]
    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 microSiemens.


Enrollment: 186
Study Start Date: November 2010
Study Completion Date: January 2015
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
Other Name: Inderal
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
1800mg, 9 tablets
Other Names:
  • Mifeprex
  • Korlym
Experimental: Intranasal oxytocin
A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.
Drug: Intranasal oxytocin
32 IU, 8 self-administered intranasal sprays, 4 in each nostril
Other Name: Syntocinon

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631682


Locations
United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Scott P. Orr, Ph.D. Massachusetts General Hospital
  More Information

Publications:
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
First Submitted: June 25, 2012
First Posted: June 29, 2012
Results First Submitted: September 13, 2016
Results First Posted: February 23, 2017
Last Update Posted: February 23, 2017
Last Verified: January 2017

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

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Mental Disorders
Trauma and Stressor Related Disorders
Oxytocin
Mifepristone
Propranolol
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Abortifacient Agents, Steroidal
Abortifacient Agents
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital
Hormone Antagonists