Disruption of Memory Reconsolidating as a Treatment for Panic Disorder

Panic Disorder Clinical Trial

Official title:

Targeting Fear Memory by Disrupting the Process of Reconsolidating: A New Intervention for Panic Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02631694
• Other study ID #: MKAEWC1
• Status: Not yet recruiting
• Phase: Phase 2
• First received: December 9, 2015
• Last updated: December 11, 2015
• Start date: April 2016
• Est. completion date: September 2019

Study information

• Verified date: December 2015
• Source: VU University of Amsterdam
• Contact: Arnold A.P. van Emmerik, PhD
• Phone: 0031205258604
• Email: A.A.P.vanEmmerik[@]uva.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2019
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Panic Disorder

Intervention

Drug:
• Propranolol
Intake of propranolol pill (40 milligram)
• Placebo
Intake of placebo pill (40 milligram)

Other:
• Carbon dioxide
Inhalation of 35% carbon dioxide
• Compressed air
Inhalation of air

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VU University of Amsterdam

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Score on the Anxiety Sensitivity Index (ASI)		Baseline	No
Primary	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		Baseline and 3 months	No
Primary	Change in score on the Panic Disorder Severity Scale (PDSS-SR)		Baseline, 7 days, 3 months	No
Secondary	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.	3 months	No
Secondary	Change in score on the Panic Appraisal Inventory (PAI)		Baseline, 7 days, 3 months, 6 months, 1 year	No
Secondary	Change in score on the Mobility Inventory (MI)		Baseline, 7 days, 3 months, 6 months, 1 year	No
Secondary	Change in score on the Body Sensations Questionnaire (BSQ)		Baseline, 7 days, 3 months, 6 months, 1 year	No
Secondary	Change in score on the Agoraphobic Cognitions Questionnaire (ACQ)		Baseline, 7 days, 3 months, 6 months, 1 year	No
Secondary	Change in the number of participants diagnosed with panic disorder assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders		Baseline, 6 months, 1 year	No
Secondary	Change in score on the Panic Disorder Severity Scale (PDSS-SR)		Baseline, 6 months, 1 year	No