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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
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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