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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
Date last updated
1/08/2023

Titles & IDs
Public title
Electroconvulsive Therapy and Concomitant Lithium in Depressive Disorder: A Pilot Study
Scientific title
Electroconvulsive Therapy and Concomitant Lithium in Depression: a Double-blind Randomized Controlled Pilot Study
Secondary ID [1] 0 0
ID: 2021-03
Secondary ID [2] 0 0
HREC/69072/MH-2021
Universal Trial Number (UTN)
Trial acronym
ECT+LITHIUM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility and safety
Timepoint [1] 0 0
Two years
Secondary outcome [1] 0 0
Total ECT sessions
Timepoint [1] 0 0
Four weeks
Secondary outcome [2] 0 0
Remission
Timepoint [2] 0 0
Four weeks
Secondary outcome [3] 0 0
Cognitive function
Timepoint [3] 0 0
Four weeks
Secondary outcome [4] 0 0
Relapse of depressive disorder in six months
Timepoint [4] 0 0
Six months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3103 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Melbourne Health
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05923476
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
A Elias
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05923476