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van CCT (UK)

van CCT (UK)

The role of fear learning in panic disorder.

- candidate number8164
- NTR NumberNTR2387
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jun-2010
- Secondary IDsNL32415.068 MEC Maastricht
- Public TitleThe role of fear learning in panic disorder.
- Scientific TitleInteroceptive fear conditioning by using interoceptive stimuli and CO2 enriched air.
- ACRONYMinteroceptive conditioning
- hypothesisWe want to establish intero-interoceptive conditioning in healthy volunteers for the better understanding of the development of panic attacks into panic disorder.
- Healt Condition(s) or Problem(s) studiedPanic disorder, CO2 challenge, Interoceptive conditioning, Interoceptive stimuli
- Inclusion criteria1. Healthy volunteers aged between 18-65 years;
2. Good physical condition.
- Exclusion criteria1. History of pulmonary disease (including asthma and lung fibrosis);
2. A psychiatric disorder;
3. History of cardiovascular disease (including cardiac failure, suspicion of infarct, cardiomyopathy, TIA, angina pectoris, arrythmias);
4. Hypertension (diastolic > 100; systolic > 170);
5. Personal or familial history of cerebral aneurysm;
6. Pregnancy;
7. Epilepsy;
8. Psychotropic medication use;
9. Use of á2- or â-blockers;
10. Idiosyncratic response to pentagastrin;
11. If participants refuse insight in deviant findings.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jul-2010
- planned closingdate31-dec-2013
- Target number of participants80
- InterventionsWe want to establish intero-interoceptive fear conditioning with a differential conditioning paradigm. We want to make use of “real” interoceptive conditioned stimuli (CS): A low respiratory load (1.43 kPa/l/s) resistance and small infusions of pentagastrin (0.2 µg/ kg) will be used as CS. CO2-enriched air is used as unconditioned stimulus (UCS). To rule out possible procedural effects also a placebo injection and placebo resistance is included in this study. The experiment consists of two parts, acquisition and test. During acquisition we want to establish conditioning (linking CS to the UCS). During the test part only the CS is given without the UCS.
- Primary outcomeThe subjective reports of the participants measured by the Visual Analogue Scale – Fear (VAS-F) during the test part.
- Secondary outcomeThe physiological responses of respiration rate, tidal volume and FetCO2 and the subjective report by Panic Symtom List (PSL) during the test part.
- TimepointsAll assesments are measured before and after each trial. The differences between the trial in the test part are important.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM)
- PublicationsN/A
- Brief summaryMore than 20% of the general population experience a panic attack once in their lives; however, only a minority goes on to develop panic disorder. The alarm theory tries to explain the etiology of panic disorder through interoceptive conditioning. To date studies concerning panic disorder and interoceptive conditioning are limited.
The aim of the present study is to establish intero-interoceptive fear conditioning in healthy participants in a differential conditioning paradigm. We want to make use of “real” interoceptive conditioned stimuli (CS): a low respiratory load and small infusions of pentagastrin will be used as CS. CO2-enriched air is used as unconditioned stimulus.
This study involves a double-blinded randomised design.Healthy volunteers with an age range between 18-65 years are included in the study. The main study outcome are the subjective reports (fear and physical symptoms) and the physiological measurements (respiration rate, tidal volume) that are assessed during the test-phase.
- Main changes (audit trail)
- RECORD21-jun-2010 - 7-jul-2010

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