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Preventing Relapse After Successful Electroconvulsive Therapy for Depression

NCT06751875 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-05-05

Study results available
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Summary

The present project is designed to study two promising relapse prevention strategies in an RCT. This will be the first project worldwide to study the effects of a personalized ECT treatment algorithm in the continuation phase of depression in an ECT-responsive population of all ages. The project holds promise for diminishing relapse rates after successful ECT, thereby being of potential impact for a vulnerable group of patients with an often-recurring form of major depressive disorder. The underinvestigated role of lithium after successful ECT is the focus of our project. In order to improve implementation options, the investigators assess self-rating of mood alongside clinician-ratings. To investigate the effectiveness of these strategies, a multidisciplinary research project with partners from UAntwerp as well as PZ Duffel, KULeuven, AZ Sint-Jan in Brugge and our Dutch partner UMC Rotterdam was set up. With the expertise, skills and patients available at the consortium participants, the research team will be able to address the challenges of the project in terms of planning and organization of the treatment and testings. This is a completely clinical study with the intent to decrease relapse rates after successful ECT. The concrete scientific objectives (SO) will be the following:

* SO1: Investigate the additive effect of lithium-addition to symptom-driven M-ECT and antidepressant treatment in preventing relapse after successful ECT.
* SO2: Validate the effectiveness of a personalized, symptom-driven approach of maintenance ECT (for 6 months) in depressive patients that have responded to an acute ECT-course.
* SO3: Compare clinician-rated mood with scores on self-rating scales.
* SO4: Evaluate the tolerability of combined continuation treatment in the two different treatment arms by assessment of cognitive functioning.

Conditions

  • Major Depressive Disorder (MDD)

Interventions

DRUG

Lithium

Patients are randomized to either receive lithium or not.

Sponsors & Collaborators

  • Universiteit Antwerpen

    lead OTHER

Principal Investigators

  • Didier Schrijvers, MD PhD · Universiteit Antwerpen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-26
Primary Completion
2024-12-01
Completion
2024-12-31

Countries

  • Belgium

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06751875 on ClinicalTrials.gov