Measuring Blood Flow in the Brain After Epileptic Activity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-05

Study Completion Date

2023-04-15

Brief Summary

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In this clinical trial, postictal phenomena (i.e., headache, delirium) will be investigated after administration of acetaminophen and nimodipine in depressed patients receiving electroconvulsive therapy (ECT). Postictal phenomena are thought to result from decreased cerebral blood flow and decreased oxygen concentration in the brain. It is expected that acetaminophen and nimodipine will reduce these postictal phenomena, compared to no treatment, because they target these mechanisms.

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Detailed Description

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Postictal phenomena, such as sensory, motor or memory deficits, headache, delirium, and psychosis, are common manifestations after electroconvulsive therapy (ECT) induced seizures. Also, postictal phenomena add to the burden of seizures in patients with epilepsy. The pathophysiology of these phenomena is poorly understood and effective treatments are not available (Fisher RS, 2000; Krauss \& Theodore, 2010). Recently, seizure-induced postictal vasoconstriction with cerebral hypoperfusion was observed in experimentally induced seizures in rats. Treatment with acetaminophen or calcium antagonists decreased hypoperfusion and postictal phenomena (Farrell, 2016, 2017).

The objective of this research is to study the effect of acetaminophen and nimodipine to reduce postictal phenomena after ECT induced seizures.

A prospective, three conditions crossover trial will be conducted, with randomized condition allocation, open-label treatment, and blinded end-point evaluation (PROBE design; Hansson, Hedner, \& Dahlof, 1992).

Thirty-three adult (age \>17 years) patients referred to treatment with ECT for a depressive episode will be included to achieve a statistical power of .80. This will be feasible in one year.

A single dose of nimodipine (60 mg) or acetaminophen (1000 mg) or no additional treatment will be given prior to a maximum of 12 ECT-sessions per patient. Patients will be randomly assigned to predefined treatment sequences. EEG and MRI measures will serve as main outcome measures, as well as psychometric tests.

Data will be stored on two separate hard disks, one including patient sensitive information for identification, the other with anonymized data only (for the sponsor).

Patients will be recruited by doctors at Rijnstate Hospital Arnhem. A mixed model with repeated measurements analysis will be conducted for the primary outcome measures.

Conditions

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Epilepsy Depression Postictal Delirium Electroconvulsive Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study makes use of a 3 x 3 crossover design, in which patients receive a randomized sequence of interventions in pairs of 3 (acetaminophen, nimodipine, no intervention), with a maximum of 12 interventions/measurements.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

The PROBE design will be used in this study, in which the principal investigator will be blinded to the administration of drugs until the end of the study. The other principal investigator will know about administration, but will not be involved in testing patients.

Study Groups

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Acetaminophen

Trade name: Paracetamol Pharmaceutical form: Tablet (oral use) Once 1000 mg 2h before the ECT-session. Total maximum of five times over the course of weeks

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

once, 1000mg, 2 h before ECT session

Nimodipine

Trade name: Nimotop Pharmaceutical form: Film-coated tablet (oral use) Once 60mg 2h before the ECT-session. Total maximum of five times over the course of weeks.

Group Type ACTIVE_COMPARATOR

Nimotop

Intervention Type DRUG

once, 60mg, 2 h before ECT session

Control

Glass of water (50cc) only. Once 2h before the ECT-session. Total maximum of five times over the course of weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Paracetamol

once, 1000mg, 2 h before ECT session

Intervention Type DRUG

Nimotop

once, 60mg, 2 h before ECT session

Intervention Type DRUG

Other Intervention Names

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RVG 107336 RVG 12060

Eligibility Criteria

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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.

Exclusion Criteria

* Known adverse or allergic reactions to acetaminophen or nimodipine;
* Chronic use of acetaminophen, calcium-antagonists or NSAID's that cannot be interrupted for less than two days before the ECT-session;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No