Disruption of Memory Reconsolidating as a Treatment for Panic Disorder

Phase 2

• Conditions: Panic Disorder
• Interventions: Drug: Propranolol; Drug: Placebo; Other: Carbon dioxide; Other: Compressed air

• Registration Number: NCT02631694
• Lead Sponsor: VU University of Amsterdam

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-12
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2015-12-11
• Last Update Submitted: 2015-12-11
• Study First Posted: 2015-12-16
• Last Update Posted: 2015-12-16
• Study Start: 2016-04
• Primary Completion: 2018-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fear reactivation with propranolol	Propranolol	-
Fear reactivation with propranolol	Carbon dioxide	-
Fear reactivation with placebo	Placebo	-
Fear reactivation with placebo	Carbon dioxide	-
No fear reactivation with propranolol	Compressed air	-
No fear reactivation with propranolol	Propranolol	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Carbon dioxide challenge using a visual analogue scale ranging from 0-100 mm	3 months	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)	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