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Electroconvulsive Therapy and Concomitant Lithium in Depressive Disorder: A Pilot Study

NCT05923476 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-08-01

No results posted yet for this study

Summary

Depression is a major psychiatric illness associated with significant morbidity and mortality. Electroconvulsive therapy (ECT) is the most effective treatment for depression and arguably the safest. However, a sizable proportion of patients (20%-30%) do not get well with ECT. Typically, ECT is given as a course extending over weeks and then discontinued. Approximately 50% of patients become unwell again in one year after the completion of ECT even when they use antidepressant medications. Moreover, ECT brings recovery after a series of treatment sessions, usually with a range of 6-20. Each ECT session poses logistic issues. Lithium has robust antidepressant effect when used with antidepressant medications. A combination of lithium and ECT has been studied previously in mania and found to be safe at a lithium level in the human body below 0.6 mEq/L. There is a gap in the literature about the use of lithium and ECT combination in depression. This pilot study aims to investigate the feasibility and safety of conducting a randomized controlled trial comparing lithium and ECT against placebo and ECT. Participants will have either placebo and ECT or lithium ECT at an equal probability. They will be approached for an expression of interest, invited to take part in a consenting session, screened for the eligibility for the study, and assessed for the severity of depression, and cognitive function and then for the improvement in depression. Lithium blood level will be monitored five days after commencement of lithium and each dose change. Participants will be assessed for adverse reactions after each ECT using a formal adverse monitoring report form. Recruitment numbers, trial retention and completion rates and adverse events will be reported.

Conditions

  • Depressive Disorder

Interventions

DRUG

Lithium

Placebo + ECT

Sponsors & Collaborators

  • Melbourne Health

    lead OTHER

Principal Investigators

  • A Elias · University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2025-05-30
Completion
2025-06-30

Countries

  • Australia

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 NCT05923476 on ClinicalTrials.gov