Preventing Relapse After Successful Electroconvulsive Therapy for Depression

NCT06751875 | Completed Results DMC

• 2 other identifiers: 19/10/126T000218N
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Lithium; Major depressive disorder; maintenance electroconvulsive therapy; ECT; relapse prevention

Outcome Measures

Primary Outcomes (1)

• Relapse Rate

  The investigators will compare the lithium-arm with the arm without lithium, as we look at the relapse rate and depression severity. Relapse rate was described as the percentage of patients in each of the two treatment arms that relapsed. Depression severity was measured using the Inventory of Depressive Symptomatology - Clinician Rated (IDS-C), a 30-item clinician-rated scale assessing the severity of depressive symptoms. Because only one of two 'appetite disturbance/body weight disturbance' items are selected for rating, the score of 28 items is added to reach a final score. Each item is scored 0-3, resulting in a total score range of 0-84, where higher scores indicate more severe depression.

  Start of Maintenance Phase with repeated assessments at fixed points for six months (1 month, 2 month, 3 month, 4 month, 5 month, and 6 month) during the maintenance period through 6-month follow-up.

Secondary Outcomes (2)

• Depression Severity Differences

  Five monthly assessments at 2, 3, 4, 5, and 6 months during the Maintenance Phase (modeled as one value).

• Cognitive Performance

  Start of Maintenance Phase, timepoint at month 1.

Study Arms (2)

Lithium arm

ACTIVE COMPARATOR

Drug: Lithium

non-Lithium arm

NO INTERVENTION

Interventions

Lithium DRUG

Patients are randomized to either receive lithium or not.

Lithium arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiteit Antwerpen: lead

Study Sites (1)

Collaborative Antwerp Psychiatric Research Institute (CAPRI)

Wilrijk, Antwerp, 2610, Belgium

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Lithium

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Metals, Alkali; Elements; Inorganic Chemicals; Metals, Light; Metals

Limitations and Caveats

\- small sample size with lesser inclusions then calculated because of study during COVID pandemy but also long study follow-up

Results Point of Contact

• Title: Didier Schrijvers
• Organization: University of Antwerp

Didier.Schrijvers@uantwerpen.be

+32 (0)15/30.40.34

Study Officials

• Didier Schrijvers, MD PhD

  Universiteit Antwerpen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Raters did not receive information about treatment group while handling the questionnaires.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: July 26, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 5, 2026
• Results First Posted: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)