E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Panic disorder |
Paniekstoornis |
|
E.1.1.1 | Medical condition in easily understood language |
Fear of sudden panic attacks |
Angst voor onverwachte paniekaanvallen |
|
E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Our study will test whether a single intervention of fear memory reactivation (35% C02 inhalation) followed by the intake of a beta-aderenergic blocker (40 mg propranolol HCl) reduces panic disorder symptoms. |
In deze studie wordt getest of een eenmalige reactivatie van het angstgeheugen (35% C02 inhalatie) gevolgd door inname van een betablokker (40 mg propranolol HCl) symptomen van paniekstoornis vermindert. |
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
Niet van toepassing |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Aged between 18 and 65 years - A primary diagnosis of panic disorder according to DSM-V - Written approval of an independent physician for participation
|
- Tussen 18 en 65 jaar oud - Paniekstoornis als primaire diagnose volgens DSM-V - Geschreven toestemming voor deelname van een onafhankelijk arts |
|
E.4 | Principal exclusion criteria |
- Other relevant treatment for panic disorder at the time of study - e.g., 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 - HR<60 - 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 |
- Andere behandeling voor paniekstoornis tijdens de studie (bijvoorbeeld cognitieve gedragstherapie) - Depressieve stoornis - Psychotische stoornis - Gebruik van psychotrope medicatie - Longaandoening - Zuurvergiftiging van het bloed (metabole acidose) - Verleden van hartklachten - Hartklachten bij eerstegraads familieleden - Hartslag lager dan 60 - Bloeddruk lager dan 90-60 of hoger dan 170-100 - Een verleden van blackouts of flauwvallen - Diabetes - Lever of nierfunctiestoornissen - Overmatige productie van het schildklierhormoon - Epilepsie - Medicatie contra-indicatief voor het gebruik van propranolol - Zwangerschap |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Absence of panic disorder diagnosis according to DSM-V (clinical interview) and a significant reduction in panic disorder symptoms (questionnaire) |
Afwezigheid van een paniekstoornis volgens DSM-V (klinisch interview) en een significante afname in paniekstoornis symptomen (vragenlijst) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Three months post-treatment |
Drie maanden na behandeling |
|
E.5.2 | Secondary end point(s) |
1 Willingness to inhale 35% C02 2 A significant reduction in negative cognitive appraisals of panic 3 A significant reduction in agoraphobic avoidance 4 A significant reduction in panic-related bodily symptoms 5 A significant reduction in anxious thoughts related to panic attacks and agoraphobic avoidance 6 Absence of panic disorder diagnosis according to DSM-V 7 A significant reduction in panic disorder symptoms |
1 Bereidheid om 35% C02 te inhaleren 2 Een significante daling in negatieve reflecties over paniek 3 Een significante daling agorafobische vermijding 4 Een significante daling in paniekgerelateerde, lichamelijke symptomen 5 Een significante daling in angstige gedachten, gerelateerd aan paniekaanvallen en agorafobische vermijding 6 Afwezigheid van een paniekstoornis volgens DSM-V 7 Een significante afname in paniekstoornis symptomen |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 Three months post-treatment 2 One week, three months, six months and one year post-treatment 3 One week, three months, six months and one year post-treatment 4 One week, three months, six months and one year post-treatment 5 One week, three months, six months and one year post-treatment 6 Six months and one year post-treatment 7 One week, six months and one year post-treatment |
1 Drie maanden na behandeling 2 Eén week, drie maanden, zes maanden en één jaar na behandeling 3 Eén week, drie maanden, zes maanden en één jaar na behandeling 4 Eén week, drie maanden, zes maanden en één jaar na behandeling 5 Eén week, drie maanden, zes maanden en één jaar na behandeling 6 Zes maanden en één jaar na behandeling 7 Eén week, zes maanden en één jaar na behandeling |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
At three months post-treatment participants can receive additional treatment. Therefore, the end of the trial is at three months after treatment of the last participant. For exploratory measures participants' complaints are also assessed at six months and one year post-treatment. |
Drie maanden na behandeling is het voor proefpersonen toegestaan om aanvullende therapie te volgen. Derhalve is het einde van de trial drie maanden na behandeling van de laatste proefpersoon. Voor exploratieve analyses worden de klachten van proefpersonen ook zes maanden en één jaar na behandeling gemeten. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |