N/A
N=96
Preventing Relapse After Successful Electroconvulsive Therapy for Depression
Major Depressive Disorder (MDD)
Bottom Line
View on ClinicalTrials.gov: NCT06751875 ↗Enrolled (actual)
96
Serious AEs
2.1%
Results posted
May 2026
Primary outcome: Primary: Relapse Rate — 7; 9 Participants — p=0.014
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lithium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Universiteit Antwerpen
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relapse Rate |
7; 9 | 0.014 sig |
| SECONDARY Depression Severity Differences |
42.7; 41.3 | 0.991 |
| SECONDARY Cognitive Performance |
23.8; 23.1 | 0.32 |
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.
Eligibility Criteria
Inclusion Criteria
- Major depressive disorder patients
- Treatment with either an adequately dosed TCA (with therapeutic blood levels) or venlafaxine (target dose of ≥ 225mg/day)
- Remitted (IDS-C≤12) after an acute course of ECT
- Age 18 or older
- If applicable, use of appropriate contraception.
Exclusion Criteria
- Patients with bipolar, schizoaffective disorder or schizophrenia
- Patients already being treated with Lithium, or with a contra-indication for its use
- Patients with documented dementia or intellectual disability
- Substance abuse or dependence in the past 6 months
- Pregnancy or breastfeeding
Data sourced from ClinicalTrials.gov (NCT06751875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.