Disruption of Memory Reconsolidating as a Treatment for Panic Disorder

Study Overview
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Brief Summary
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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.

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

Conditions
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Panic Disorder

Intervention / Treatment
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* Drug: Propranolol
* Drug: Placebo
* Other: Carbon dioxide
* Other: Compressed air


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |