E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Headaches occuring after electro conculsion therapy. |
Hoofdpijn die optreed na elektroconvulsietherapie. |
|
E.1.1.1 | Medical condition in easily understood language |
Headaches occuring after electro conculsion therapy. |
Hoofdpijn die optreed na elektroconvulsietherapy. |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
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 |
Reduction of headache complaints after electro convulsion therapy. Effect of treatment is defined as a reduction of headache on the VRS (verbal rating scale), from 2 or 3 to equal or less than 1. |
Verminderen van hoofdpijnklcahten die optreden na ECT-behandeling.
Een behandeleffect wordt gedefinieerd als een vermindering van de hoofdpijn op de VRS (verbal rating scale) van 2 of 3 naar minder dan of gelijk aan 1. |
|
E.2.2 | Secondary objectives of the trial |
Time untill the treatment effect. It is expected that oxygen therapy will result in an imediate reduction of headache, as it is the case in treatment of cluster headache.
Duration of treatment effect. It is expected that reduction of headache will last for at least 2 hours. |
Tijdsduur tot een behandeleffect optreed. Er wordt verwacht dat het effect van zuurstoftoediening of de hoofdpijnklachten direct optreed, zoals dat ook bij de behandeling van clusterhoofdpijn het geval is.
Duur van het behandeleffect. Het wordt verwacht dat de vermindering van hoofdpijnklachten ten minste twee uur aanhoudt. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age older than 18
Indication for ECT for psychiatric illness.
Hospitalized in the department ZPO of the Reinier van Arkel groep |
Leeftijd ouder dan 18 jaar
Indicatie voor ECT behandeling voor psychiatrische klachten.
Klinisch opgenomen binnen het Centrum voor ouderen en ziekenhuispsychiatrie van Reinier van Arkel, locatie Jeroen Bosch ziekenhuis. |
|
E.4 | Principal exclusion criteria |
COPD
Current use of bleomycine, or in the past 12 months
Patients with a custody measure
Patients who are mentally incompetent regarding the decision of participation in the study, or undergo trial operations
Patients who suffer from panic attacks
Patients with a VRS-score equal or less than 1 after ECT
Patients with a VRS-score more than 1 before ECT |
COPD
Huidig gebruik van bleomycine, of in de afgelopen 12 maanden
Patiënten met IBS of voorlopige Rechterlijke Machtiging.
Wilsonbekwaamheid ten aanzien van het besluit voor deelname aan de studie, of het ondergaan van studiehandelingen.
Patienten die lijden aan paniekaanvallen
Patienten met een VRS-score kleiner of gelijk aan 1, na ECT
Patienten met een VRS-score groter dan 1 vóór ECT |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Reduction of headache from a score of 2 or 3 on the verbal rating scale (VRS) to equal or less than 1.. |
Vermindering van hoofdpijnklcahten van 2 of 3, naar minder dan of gelijk aan 1 op de verbal rating scale (VRS) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Treatment effect will be measured after ECT, after oxygen therapy and after 60 and 120 minutes after oxygen therapy. |
Behandeleffect zal worden gemeten na ECT, direct na zuurstofbehandeling en na 60 en 120 minuten na zuurstofbehandeling. |
|
E.5.2 | Secondary end point(s) |
not applicable |
niet van toepassing |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Niet van toepassing |
|
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.2.3 | Other | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |