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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VU University of Amsterdam

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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