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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05923476
Registration number
NCT05923476
Ethics application status
Date submitted
20/06/2023
Date registered
28/06/2023
Titles & IDs
Public title
Electroconvulsive Therapy and Concomitant Lithium in Depressive Disorder: A Pilot Study
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Scientific title
Electroconvulsive Therapy and Concomitant Lithium in Depression: a Double-blind Randomized Controlled Pilot Study
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Secondary ID [1]
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ID: 2021-03
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Secondary ID [2]
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HREC/69072/MH-2021
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Universal Trial Number (UTN)
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Trial acronym
ECT+LITHIUM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder
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Condition category
Condition code
Mental Health
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Depression
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Lithium
Experimental: Intervention arm - Lithium and ECT will be administered concomitantly to the intervention group
Placebo comparator: Control arm - Placebo and ECT will be administered to the control group
Treatment: Drugs: Lithium
Placebo + ECT
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Feasibility and safety
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Assessment method [1]
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Number of participants recruited, retention and completion rate and adverse events
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Timepoint [1]
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Two years
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Secondary outcome [1]
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Total ECT sessions
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Assessment method [1]
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Number of ECT required
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Timepoint [1]
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Four weeks
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Secondary outcome [2]
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Remission
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Assessment method [2]
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Rate of remission
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Timepoint [2]
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Four weeks
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Secondary outcome [3]
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Cognitive function
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Assessment method [3]
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Rate of delirium
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Timepoint [3]
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Four weeks
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Secondary outcome [4]
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Relapse of depressive disorder in six months
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Assessment method [4]
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Rate of relapse of depression
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Timepoint [4]
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Six months
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Eligibility
Key inclusion criteria
* 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 0
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2025
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Hospital - Melbourne
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Recruitment postcode(s) [1]
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3103 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Melbourne Health
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05923476
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A Elias
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Address
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University of Melbourne
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05923476