Pharmacopsychiatry 2024; 57(06): 290-295
DOI: 10.1055/a-2364-4357
Original Paper

Electroconvulsive Therapy Versus Aripiprazole Addition to Clozapine in Patients with Clozapine-Resistant Symptoms (EMECLO): A Protocol of a Single-Blind, Multicenter, Randomized-Controlled Feasibility Trial

Manouk den Toom#
1   Department of Psychiatry, Amsterdam UMC, The Netherlands
,
Laura Blanken#
1   Department of Psychiatry, Amsterdam UMC, The Netherlands
2   Department of Psychiatry, Dijklander Ziekenhuis, Hoorn, Netherlands
,
Inge Horn
3   MS centrum, Amsterdam UMC, The Netherlands
,
Selene Veerman
4   Mental Health Service Noord Holland Noord, The Netherlands
,
Joris J. B. van der Vlugt-Molenaar
5   Antes – Parnassia Group, Rotterdam, The Netherlands
,
Mariken B. de Koning
6   Arkin Mental Health Care, Amsterdam, The Netherlands
,
Jan Bogers
7   Mental Health Service Rivierduinen, High Care Clinics and Rivierduinen Academy, Leiden, The Netherlands
,
John Enterman
8   Parnassia, The Hague, The Netherlands
,
Martin de Jonge
9   Pro Persona, Arnhem, The Netherlands
,
Daniela Cianci
10   Department of Psychiatry, UMC Utrecht Brain Center
,
Gerardus W. J. Frederix
4   Mental Health Service Noord Holland Noord, The Netherlands
,
Hans J. de Haas
1   Department of Psychiatry, Amsterdam UMC, The Netherlands
6   Arkin Mental Health Care, Amsterdam, The Netherlands
,
Bram W. Storosum
1   Department of Psychiatry, Amsterdam UMC, The Netherlands
,
Mike Veereschild
11   GGNet Mental Health, Warnsveld, The Netherlands
,
Martin Javadzadeh
11   GGNet Mental Health, Warnsveld, The Netherlands
,
Peter F. J. Schulte
4   Mental Health Service Noord Holland Noord, The Netherlands
,
Dan Cohen
4   Mental Health Service Noord Holland Noord, The Netherlands
,
Jim van Os
10   Department of Psychiatry, UMC Utrecht Brain Center
,
Wiepke Cahn
10   Department of Psychiatry, UMC Utrecht Brain Center
,
Lieuwe de Haan
1   Department of Psychiatry, Amsterdam UMC, The Netherlands
6   Arkin Mental Health Care, Amsterdam, The Netherlands
,
Jasper B. Zantvoord#
1   Department of Psychiatry, Amsterdam UMC, The Netherlands
,
Jurjen J. Luykx#
1   Department of Psychiatry, Amsterdam UMC, The Netherlands
12   Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University Medical Center, Maastricht, The Netherlands
13   GGZ InGeest Mental Health Care, Amsterdam, The Netherlands
› Author Affiliations

Funding ZonMw — http://dx.doi.org/10.13039/501100001826; 10390052010006
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Abstract

Background Currently, guidance on the most effective treatment for patients with clozapine-resistant schizophrenia-spectrum disorders (SSD) is lacking. While augmentation strategies to clozapine with aripiprazole and electroconvulsive therapy (ECT) have been demonstrated to be effective in patients with clozapine-resistant schizophrenia spectrum disorders (CRS), head-to-head comparisons between these addition strategies are unavailable. We therefore aim to examine the feasibility of a larger randomized, single-blind trial comparing the effectiveness, cost-effectiveness, and safety of aripiprazole addition vs. ECT addition in CRS.

Methods In this multi-center, randomized, single-blind feasibility study, the feasibility of recruiting 20 participants with CRS who will be randomized to either aripiprazole or bilateral ECT addition will be assessed. The main endpoint is the number of patients willing to be randomized. The number of screened individuals and reasons to decline participation will be recorded. Effects will be estimated for the benefit of the foreseen larger trial. To that end, differences between both arms in symptom severity will be assessed using blinded video assessments. In addition, tolerability (e. g., cognitive functioning), safety, quality of life, recovery, and all-cause discontinuation will be compared. The follow-up period is 16 weeks, after which non-responders will be given the option to switch to the other treatment.

Discussion Strengths of this feasibility trial include maintaining blinding with video assessment, a possibility to switch groups in case of non-response, and a broad set of outcome measures. Identification of factors contributing to non-participation and drop-out will generate valuable information on trial feasibility and may enhance recruitment strategies in a follow-up RCT.

Trial registration The study has been approved by the Medical Research Ethics Committee of the Amsterdam University Medical Center, location AMC, and was registered on 1 May 2022 in the EU Clinical Trials Register (EudraCT) under the trial name ‘EMECLO’ (2021–006333–19).

# These authors contributed equally: Manouk den Toom, Laura Blanken, Jasper B. Zantvoord, Jurjen J. Luykx.


Supplementary Material



Publication History

Received: 22 February 2024

Accepted after revision: 21 May 2024

Article published online:
26 August 2024

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