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

NCT05923476 | Unknown Early Phase 1 DMC

• 2 other identifiers: HREC/69072/MH-2021ID: 2021-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Feasibility and safety

  Number of participants recruited, retention and completion rate and adverse events

  Two years

Secondary Outcomes (4)

• Total ECT sessions

  Four weeks

• Remission

  Four weeks

• Cognitive function

  Four weeks

• Relapse of depressive disorder in six months

  Six months

Study Arms (2)

Intervention arm

EXPERIMENTAL

Lithium and ECT will be administered concomitantly to the intervention group

Drug: Lithium

Control arm

PLACEBO COMPARATOR

Placebo and ECT will be administered to the control group

Drug: Lithium

Interventions

Lithium DRUG

Placebo + ECT

Also known as: Lithicarb

Control arm; Intervention arm

Eligibility Criteria

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

You may qualify if:

• A depressive episode either in the context of Major Depressive Disorder or bipolar disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, DSM-V, criteria.
• Hamilton Rating Scale for Depression (HRSD 28-item) score of 18 or more.
• Participants who were prescribed ECT as part of standard care.
• Provides written informed consent.

You may not qualify if:

• Age below 18 years.
• Contraindication for lithium: renal dysfunction; cardiac disease; concomitant nonsteroidal anti-inflammatory drugs, angiotensin inhibitors and diuretics.
• Neurocognitive disorder (dementia) as defined by DSM-V criteria.
• Serious medical conditions that may preclude ECT or lithium.
• Current or history of non-mood disorder psychosis.
• Pregnancy and lactation based on clinical history and urine pregnancy test.
• A previous history of adverse events to lithium or previous history of lithium toxicity.

Sponsors & Collaborators

• Melbourne Health: lead

Study Sites (1)

Hospital

Melbourne, Victoria, 3103, Australia

Location

MeSH Terms

Conditions

Depressive Disorder

Interventions

Lithium

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• A Elias

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 28, 2023
• Study Start: June 1, 2023
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: August 1, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)