Clinical trial NCT02631694: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Panic Disorder
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: Baseline and 3 months
measure: Change in score on the Panic Disorder Severity Scale (PDSS-SR)
timeFrame: Baseline, 7 days, 3 months
Secondary outcomes:
measure: Carbon dioxide challenge using a visual analogue scale ranging from 0-100 mm
timeFrame: 3 months
measure: Change in score on the Panic Appraisal Inventory (PAI)
timeFrame: Baseline, 7 days, 3 months, 6 months, 1 year
measure: Change in score on the Mobility Inventory (MI)
timeFrame: Baseline, 7 days, 3 months, 6 months, 1 year
measure: Change in score on the Body Sensations Questionnaire (BSQ)
timeFrame: Baseline, 7 days, 3 months, 6 months, 1 year
measure: Change in score on the Agoraphobic Cognitions Questionnaire (ACQ)
timeFrame: Baseline, 7 days, 3 months, 6 months, 1 year
measure: Change in the number of participants diagnosed with panic disorder assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders
timeFrame: Baseline, 6 months, 1 year
measure: Change in score on the Panic Disorder Severity Scale (PDSS-SR)
timeFrame: Baseline, 6 months, 1 year
Other outcomes:
measure: Score on the Anxiety Sensitivity Index (ASI)
timeFrame: Baseline
Locations:
Study officials:
affiliation: University of Amsterdam
name: Merel Kindt, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: