E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postictal phenomena after electroconvulsive therapy (ECT) induced seizures. |
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E.1.1.1 | Medical condition in easily understood language |
Symptoms after a seizure in electroconvulsive therapy (ECT). |
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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 |
Does treatment with drugs modulating vasoconstriction, i.e. COX-inhibitors (acetaminophen) or calcium-antagonists (nimodipine), improve electrographic postictal phenomena? |
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E.2.2 | Secondary objectives of the trial |
Does treatment with acetaminophen or nimodipine improve ‘time to orientation’? Does treatment with paracetamol or nimodipine prevent or limit postictal hypoperfusion? Are clinical and electrographic postictal phenomena associated with brain perfusion and function?
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adulthood (age > 17 years); Current clinical diagnosis of depressive episode (unipolar, bipolar, schizoaffective); Willingness and ability to give written informed consent and willingness and ability to understand, to participate and to comply with the study requirements.
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E.4 | Principal exclusion criteria |
Known adverse or allergic reactions to acetaminophen or nimodipine;
Chronic use of acetaminophen,calcium-antagonistsor NSAID’s that cannot be interrupted for less than two daysbefore the ECT-session;
Contraindications for magnetic resonance imaging (e.g. ferromagnetic implants, pacemakers).
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E.5 End points |
E.5.1 | Primary end point(s) |
‘Time to EEG normalization’, defined as the time interval between seizure onset and return to the pre-ECT (baseline) EEG, quantified with the temporal Brain Symmetry Index. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint is measured after each ECT-session. |
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E.5.2 | Secondary end point(s) |
Clinical measures : - ‘Orientation recovery time’, defined as the time-interval between seizure onset and orientation in time, person, and place. - The incidence and severity of headache, nausea and myalgia as measured using a visual analogue scale.
EEG measures: - The alpha/delta ratio derived from the EEG as a function of time after ECT. This ratio will be fitted to a sigmoid function, allowing to extract the ‘postictal recovery time constant (PRTC)’. - The cerebral recovery index (CRI) which is based on the evolution of several qEEG features over time.
MRI measures within one hour after seizure termination. - Cerebral perfusion: MRI with Arterial Spin Labeling (pCASL sequence on 3T Philips scanner) will be used measure perfusion levels. - Vessel diameter as measured with MRA. - Resting state activity and functional connectivity as measured by BOLD fMRI. - Structural MRI will be collected using isovoxel T1-weighted data to make volumetric changes during the ECT-course possible. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Clinical measures: after each ECT-session. EEG measures: after each ECT-session. MRI measures: within one hour of the ECT-session. Participants will undergo one MRI-scan per condition (equals to three ECT-sessions). |
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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) | 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 | 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 | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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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 | Yes |
E.8.2.3.1 | Comparator description |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |