Electroconvulsive Therapy and Concomitant Lithium in Depressive Disorder: A Pilot Study - Trial NCT05923476

Timeline & Enrollment

Primary Outcome

Feasibility and safety

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.

ICD-10 Classifications