Disruption of Memory Reconsolidating as a Treatment for Panic Disorder

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

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.

Study Overview

• Status: Unknown
• Conditions: Panic Disorder
• Intervention / Treatment: Drug: Propranolol; Other: Carbon dioxide; Drug: Placebo; Other: Compressed air

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Arnold A.P. van Emmerik, PhD; Phone Number: 0031205258604; Email: A.A.P.vanEmmerik@uva.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fear reactivation with propranolol	Drug: Propranolol; Intake of propranolol pill (40 milligram); Other: Carbon dioxide; Inhalation of 35% carbon dioxide
Placebo Comparator: Fear reactivation with placebo	Other: Carbon dioxide; Inhalation of 35% carbon dioxide; Drug: Placebo; Intake of placebo pill (40 milligram)
Placebo Comparator: No fear reactivation with propranolol	Drug: Propranolol; Intake of propranolol pill (40 milligram); Other: Compressed air; Inhalation of air

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Change in score on the Panic Disorder Severity Scale (PDSS-SR)	Baseline, 7 days, 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in score on the Panic Appraisal Inventory (PAI)		Baseline, 7 days, 3 months, 6 months, 1 year
Change in score on the Mobility Inventory (MI)		Baseline, 7 days, 3 months, 6 months, 1 year
Change in score on the Body Sensations Questionnaire (BSQ)		Baseline, 7 days, 3 months, 6 months, 1 year
Change in score on the Agoraphobic Cognitions Questionnaire (ACQ)		Baseline, 7 days, 3 months, 6 months, 1 year
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
Change in score on the Panic Disorder Severity Scale (PDSS-SR)		Baseline, 6 months, 1 year

Other Outcome Measures

Outcome Measure	Time Frame
Score on the Anxiety Sensitivity Index (ASI)	Baseline

Collaborators and Investigators

• Sponsor: VU University of Amsterdam
• Investigators: Principal Investigator: Merel Kindt, Prof. dr., University of Amsterdam

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): September 1, 2019

Study Registration Dates

• First Submitted: December 9, 2015
• First Submitted That Met QC Criteria: December 11, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 11, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Panic Disorder; 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; Propranolol
• Other Study ID Numbers: MKAEWC1