NCT02631694

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2016

Typical duration for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

December 16, 2015

Status Verified

December 1, 2015

Enrollment Period

2.4 years

First QC Date

December 9, 2015

Last Update Submit

December 11, 2015

Conditions

Panic Disorder

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • Carbon dioxide challenge using a visual analogue scale ranging from 0-100 mm

    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

  • +2 more secondary outcomes

Other Outcomes (1)

  • Score on the Anxiety Sensitivity Index (ASI)

    Baseline

Study Arms (3)

Fear reactivation with propranolol

EXPERIMENTAL
Drug: PropranololOther: Carbon dioxide

Fear reactivation with placebo

PLACEBO COMPARATOR
Drug: PlaceboOther: Carbon dioxide

No fear reactivation with propranolol

PLACEBO COMPARATOR
Drug: PropranololOther: Compressed air

Interventions

PropranololDRUG

Intake of propranolol pill (40 milligram)

Fear reactivation with propranololNo fear reactivation with propranolol
PlaceboDRUG

Intake of placebo pill (40 milligram)

Fear reactivation with placebo
Carbon dioxideOTHER

Inhalation of 35% carbon dioxide

Fear reactivation with placeboFear reactivation with propranolol
Compressed airOTHER

Inhalation of air

No fear reactivation with propranolol

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a primary diagnosis of panic disorder according to DSM-V
  • written approval of an independent physician for participation

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Panic Disorder

Interventions

PropranololCarbon DioxideCompressed Air

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsCarbon Compounds, InorganicInorganic ChemicalsGasesOxidesOxygen CompoundsEquipment and SuppliesAirAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Merel Kindt, Prof. dr.

    University of Amsterdam

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnold A.P. van Emmerik, PhD

CONTACT

0031205258604A.A.P.vanEmmerik@uva.nl

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Experimental and Clinical Psychology

Study Record Dates

First Submitted

December 9, 2015

First Posted

December 16, 2015

Study Start

April 1, 2016

Primary Completion

September 1, 2018

Study Completion

September 1, 2019

Last Updated

December 16, 2015

Record last verified: 2015-12