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Randomized Controlled Trial
. 2024 Jun 28;19(6):e0303894.
doi: 10.1371/journal.pone.0303894. eCollection 2024.

Electroconvulsive therapy for the acute management of severe agitation in dementia (ECT-AD): A modified study protocol

Maria I Lapid  1 , Julia Merrill  2 , Martina Mueller  3   4 , Adriana P Hermida  5 , Louis Nykamp  6 , Jason Andrus  7   8   9 , Heela Azizi  7   8   10 , Paula Bolton  2 , Nana Bonsu  5 , Raphael Braga  7   8   9 , Catherine R Dillon  4 , Donna Ecklesdafer  6 , Darci Evans  6 , David Harper  2   11 , Hannah Heintz  2 , Sehba Hussain-Krauter  12 , Olivia Holzgen  6 , Daniel Humphrey  3 , Salima Jiwani  7   8   9 , Emily K Johnson  1 , Simran Kang  7   8   10 , Janelle Kassien  6 , Jonathan Kim  5 , Rebecca G Knapp  4 , Simon Kung  1 , Neil Kremen  7   8   9 , Kendra Le  5 , Jack Mahdasian  6 , Taylor Marzouk  7   8   10 , Jared D Masrud  1 , Jefferson Mattingly  2 , Dawn Miller  6 , Sandeep R Pagali  13 , Regan Patrick  2   11 , Patricio Riva Posse  5 , Cristina Pritchett  5 , Aniqa Rahman  2 , Swapnil Rath  6 , Cara Roczniak  6 , Teresa A Rummans  1 , Sohag Sanghani  7   8   9 , Steve Seiner  7 , LeAnn Smart  6 , Evan Tomaschek  4 , Valeriya Tsygankova  5 , Lori VanderSchuur-White  6 , Monica P Walton  14 , James Wilkins  2   11 , April Williams  4 , Sarah M Williams  1 , George Petrides  7   8   9   15 , Brent P Forester  2   11   16
Affiliations
Randomized Controlled Trial

Electroconvulsive therapy for the acute management of severe agitation in dementia (ECT-AD): A modified study protocol

Maria I Lapid et al. PLoS One. .

Abstract

Objective: This study began as a single-blind randomized controlled trial (RCT) to investigate the efficacy and safety of electroconvulsive therapy (ECT) for severe treatment-refractory agitation in advanced dementia. The aims are to assess agitation reduction using the Cohen-Mansfield Agitation Inventory (CMAI), evaluate tolerability and safety outcomes, and explore the long-term stability of agitation reduction and global functioning. Due to challenges encountered during implementation, including recruitment obstacles and operational difficulties, the study design was modified to an open-label format and other protocol amendments were implemented.

Methods: Initially, the RCT randomized participants 1:1 to either ECT plus usual care or simulated ECT plus usual care (S-ECT) groups. As patients were enrolled, data were collected from both ECT and simulated ECT (S-ECT) patients. The study now continues in an open-label study design where all patients receive actual ECT, reducing the targeted sample size from 200 to 50 participants.

Results: Study is ongoing and open to enrollment.

Conclusion: The transition of the ECT-AD study design from an RCT to open-label design exemplifies adaptive research methodologies in response to real-world challenges. Data from both the RCT and open-label phases of the study will provide a unique perspective on the role of ECT in managing severe treatment-refractory agitation in dementia, potentially influencing future clinical practices and research approaches.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. SPIRIT figure.
Fig 2
Fig 2. Assent/dissent flow chart.
See this image and copyright information in PMC

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