Panic DisorderPhase 2NCT02631694
Disruption of Memory Reconsolidating as a Treatment for Panic Disorder
A Phase 2 study testing Propranolol, Carbon dioxide and Compressed air in people with Panic Disorder, run by VU University of Amsterdam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Propranolol, Carbon dioxide and Compressed air
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Sep 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a primary diagnosis of panic disorder according to DSM-V
- written approval of an independent physician for participation
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Panic Disorder
- Being tested
- Propranolol, Placebo, Carbon dioxide, Compressed air
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
Intake of propranolol pill (40 milligram)
PlaceboDrug
Intake of placebo pill (40 milligram)
Carbon dioxideOther
Inhalation of 35% carbon dioxide
Compressed airOther
Inhalation of air
| Study group | Role | What they receive |
|---|---|---|
| Fear reactivation with propranolol | Experimental | Not described Receives: Drug: Propranolol; Other: Carbon dioxide |
| Fear reactivation with placebo | Placebo comparator | Not described Receives: Drug: Placebo; Other: Carbon dioxide |
| No fear reactivation with propranolol | Placebo comparator | Not described Receives: Drug: Propranolol; Other: Compressed air |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 3 months
Change in score on the Panic Disorder Severity Scale (PDSS-SR)
Measured: Baseline, 7 days, 3 months
Secondary outcomes (7)
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.
Measured: 3 months
Change in score on the Panic Appraisal Inventory (PAI)
Measured: Baseline, 7 days, 3 months, 6 months, 1 year
Change in score on the Mobility Inventory (MI)
Measured: Baseline, 7 days, 3 months, 6 months, 1 year
Change in score on the Body Sensations Questionnaire (BSQ)
Measured: Baseline, 7 days, 3 months, 6 months, 1 year
Change in score on the Agoraphobic Cognitions Questionnaire (ACQ)
Measured: 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
Measured: Baseline, 6 months, 1 year
Change in score on the Panic Disorder Severity Scale (PDSS-SR)
Measured: Baseline, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startApr 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mrs. M. Kindt, VU University of Amsterdam
- Investigators
- Merel Kindt, Prof. dr., Principal investigator, University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02631694
- Sponsor's protocol ID
- MKAEWC1
- Status last verified
- Dec 2015
- First submitted
- 9 Dec 2015
- Last updated
- 16 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Fear Memory by Disrupting the Process of Reconsolidating: A New Intervention for Panic Disorder
- ClinicalTrials.gov ID
- NCT02631694
- Acronym / sponsor ID
- MKAEWC1
- Conditions
- Panic Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 16 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fear reactivation with propranolol | Experimental | Drug: Propranolol, Other: Carbon dioxide |
| Fear reactivation with placebo | Placebo comparator | Drug: Placebo, Other: Carbon dioxide |
| No fear reactivation with propranolol | Placebo comparator | Drug: Propranolol, Other: Compressed air |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a primary diagnosis of panic disorder according to DSM-V
- written approval of an independent physician for participation
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololIntake of propranolol pill (40 milligram) | Drug | Fear reactivation with propranolol, No fear reactivation with propranolol |
| PlaceboIntake of placebo pill (40 milligram) | Drug | Fear reactivation with placebo |
| Carbon dioxideInhalation of 35% carbon dioxide | Other | Fear reactivation with placebo, Fear reactivation with propranolol |
| Compressed airInhalation of air | Other | No fear reactivation with propranolol |
Primary outcome
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
Change in score on the Panic Disorder Severity Scale (PDSS-SR)
Time frame: Baseline, 7 days, 3 months
7 secondary outcomes
Carbon dioxide challenge using a visual analogue scale ranging from 0-100 mm
Time frame: 3 months
Change in score on the Panic Appraisal Inventory (PAI)
Time frame: 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
Change in score on the Body Sensations Questionnaire (BSQ)
Time frame: 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
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
Change in score on the Panic Disorder Severity Scale (PDSS-SR)
Time frame: Baseline, 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merel Kindt, Prof. dr. principal investigator
University of Amsterdam
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol, Carbon dioxide and Compressed air in people with Panic Disorder, run by VU University of Amsterdam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnold A.P. van Emmerik, PhD (0031205258604, A.A.P.vanEmmerik@uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.