- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02631694
Disruption of Memory Reconsolidating as a Treatment for Panic Disorder
December 11, 2015 updated by: Mrs. M. Kindt, VU University of Amsterdam
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arnold A.P. van Emmerik, PhD
- Phone Number: 0031205258604
- Email: A.A.P.vanEmmerik@uva.nl
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Fear reactivation with propranolol
|
Intake of propranolol pill (40 milligram)
Inhalation of 35% carbon dioxide
|
Placebo Comparator: Fear reactivation with placebo
|
Inhalation of 35% carbon dioxide
Intake of placebo pill (40 milligram)
|
Placebo Comparator: No fear reactivation with propranolol
|
Intake of propranolol pill (40 milligram)
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
Time Frame: Baseline and 3 months
|
Baseline and 3 months
|
Change in score on the Panic Disorder Severity Scale (PDSS-SR)
Time Frame: Baseline, 7 days, 3 months
|
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
Time Frame: 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.
|
3 months
|
Change in score on the Panic Appraisal Inventory (PAI)
Time Frame: Baseline, 7 days, 3 months, 6 months, 1 year
|
Baseline, 7 days, 3 months, 6 months, 1 year
|
|
Change in score on the Mobility Inventory (MI)
Time Frame: Baseline, 7 days, 3 months, 6 months, 1 year
|
Baseline, 7 days, 3 months, 6 months, 1 year
|
|
Change in score on the Body Sensations Questionnaire (BSQ)
Time Frame: Baseline, 7 days, 3 months, 6 months, 1 year
|
Baseline, 7 days, 3 months, 6 months, 1 year
|
|
Change in score on the Agoraphobic Cognitions Questionnaire (ACQ)
Time Frame: Baseline, 7 days, 3 months, 6 months, 1 year
|
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
Time Frame: Baseline, 6 months, 1 year
|
Baseline, 6 months, 1 year
|
|
Change in score on the Panic Disorder Severity Scale (PDSS-SR)
Time Frame: Baseline, 6 months, 1 year
|
Baseline, 6 months, 1 year
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Score on the Anxiety Sensitivity Index (ASI)
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Merel Kindt, Prof. dr., University of Amsterdam
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- MKAEWC1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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