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Disruption of Memory Reconsolidating as a Treatment for Panic Disorder

Primary Purpose

Panic Disorder

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Propranolol
Placebo
Carbon dioxide
Compressed air
Sponsored by
VU University of Amsterdam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Panic Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • a primary diagnosis of panic disorder according to DSM-V
  • written approval of an independent physician for participation

Exclusion Criteria:

  • other relevant treatment for panic disorder at the time of study - e.g., Cognitive Behavioral Therapy (CBT)
  • diagnosis of depression
  • diagnosis of psychosis
  • use of psychotropic medication
  • history of pulmonary diseases
  • metabolic acidosis
  • history of cardiovascular diseases
  • heart problems among first-degree relatives
  • heart rate (HR) < 60
  • blood pressure (BP) < 90-60 or BP > 170-100
  • history of black-outs or fainting
  • diabetes
  • liver or kidney diseases
  • hyperactive production of thyroid hormones
  • epilepsy
  • any medication contra-indicative of the use of propranolol
  • pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Placebo Comparator

    Placebo Comparator

    Arm Label

    Fear reactivation with propranolol

    Fear reactivation with placebo

    No fear reactivation with propranolol

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in the number of participants diagnosed with panic disorder assessed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fourth addition (DSM-IV) Axis I Disorders
    Change in score on the Panic Disorder Severity Scale (PDSS-SR)

    Secondary Outcome Measures

    Carbon dioxide challenge using a visual analogue scale ranging from 0-100 mm
    Participants are asked to rate on a visual analogue scale ranging from 0-100 mm the degree to which they are willing to inhale carbon dioxide again if this were requested. Secondly, participants will indeed be requested to perform the challenge a second time and rate on the visual analogue scale how anxious it made them feel.
    Change in score on the Panic Appraisal Inventory (PAI)
    Change in score on the Mobility Inventory (MI)
    Change in score on the Body Sensations Questionnaire (BSQ)
    Change in score on the Agoraphobic Cognitions Questionnaire (ACQ)
    Change in the number of participants diagnosed with panic disorder assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders
    Change in score on the Panic Disorder Severity Scale (PDSS-SR)

    Full Information

    First Posted
    December 9, 2015
    Last Updated
    December 11, 2015
    Sponsor
    VU University of Amsterdam
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02631694
    Brief Title
    Disruption of Memory Reconsolidating as a Treatment for Panic Disorder
    Official Title
    Targeting Fear Memory by Disrupting the Process of Reconsolidating: A New Intervention for Panic Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2016 (undefined)
    Primary Completion Date
    September 2018 (Anticipated)
    Study Completion Date
    September 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    VU University of Amsterdam

    4. Oversight

    5. Study Description

    Brief Summary
    Animal and human fear conditioning studies have repeatedly shown that administering propranolol before or after retrieval of a previously acquired fear results in an elimination of the fear expression. This approach, known as disruption of fear memory reconsolidation, is a promising new avenue for treating anxiety disorders. The present study aims to test its efficacy in patients with panic disorder.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Panic Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fear reactivation with propranolol
    Arm Type
    Experimental
    Arm Title
    Fear reactivation with placebo
    Arm Type
    Placebo Comparator
    Arm Title
    No fear reactivation with propranolol
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Propranolol
    Intervention Description
    Intake of propranolol pill (40 milligram)
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Intake of placebo pill (40 milligram)
    Intervention Type
    Other
    Intervention Name(s)
    Carbon dioxide
    Intervention Description
    Inhalation of 35% carbon dioxide
    Intervention Type
    Other
    Intervention Name(s)
    Compressed air
    Intervention Description
    Inhalation of air
    Primary Outcome Measure Information:
    Title
    Change in the number of participants diagnosed with panic disorder assessed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fourth addition (DSM-IV) Axis I Disorders
    Time Frame
    Baseline and 3 months
    Title
    Change in score on the Panic Disorder Severity Scale (PDSS-SR)
    Time Frame
    Baseline, 7 days, 3 months
    Secondary Outcome Measure Information:
    Title
    Carbon dioxide challenge using a visual analogue scale ranging from 0-100 mm
    Description
    Participants are asked to rate on a visual analogue scale ranging from 0-100 mm the degree to which they are willing to inhale carbon dioxide again if this were requested. Secondly, participants will indeed be requested to perform the challenge a second time and rate on the visual analogue scale how anxious it made them feel.
    Time Frame
    3 months
    Title
    Change in score on the Panic Appraisal Inventory (PAI)
    Time Frame
    Baseline, 7 days, 3 months, 6 months, 1 year
    Title
    Change in score on the Mobility Inventory (MI)
    Time Frame
    Baseline, 7 days, 3 months, 6 months, 1 year
    Title
    Change in score on the Body Sensations Questionnaire (BSQ)
    Time Frame
    Baseline, 7 days, 3 months, 6 months, 1 year
    Title
    Change in score on the Agoraphobic Cognitions Questionnaire (ACQ)
    Time Frame
    Baseline, 7 days, 3 months, 6 months, 1 year
    Title
    Change in the number of participants diagnosed with panic disorder assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders
    Time Frame
    Baseline, 6 months, 1 year
    Title
    Change in score on the Panic Disorder Severity Scale (PDSS-SR)
    Time Frame
    Baseline, 6 months, 1 year
    Other Pre-specified Outcome Measures:
    Title
    Score on the Anxiety Sensitivity Index (ASI)
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: a primary diagnosis of panic disorder according to DSM-V written approval of an independent physician for participation Exclusion Criteria: other relevant treatment for panic disorder at the time of study - e.g., Cognitive Behavioral Therapy (CBT) diagnosis of depression diagnosis of psychosis use of psychotropic medication history of pulmonary diseases metabolic acidosis history of cardiovascular diseases heart problems among first-degree relatives heart rate (HR) < 60 blood pressure (BP) < 90-60 or BP > 170-100 history of black-outs or fainting diabetes liver or kidney diseases hyperactive production of thyroid hormones epilepsy any medication contra-indicative of the use of propranolol pregnancy
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arnold A.P. van Emmerik, PhD
    Phone
    0031205258604
    Email
    A.A.P.vanEmmerik@uva.nl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Merel Kindt, Prof. dr.
    Organizational Affiliation
    University of Amsterdam
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Disruption of Memory Reconsolidating as a Treatment for Panic Disorder

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