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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03297411




Registration number
NCT03297411
Ethics application status
Date submitted
14/09/2017
Date registered
29/09/2017
Date last updated
16/05/2018

Titles & IDs
Public title
Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling
Scientific title
Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling
Secondary ID [1] 0 0
HC17286
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Brief Temporoparietal ECT
Treatment: Surgery - Ultrabrief Temporoparietal ECT
Treatment: Surgery - Brief Frontoparietal ECT
Treatment: Surgery - Ultrabrief Frontoparietal ECT

Active comparator: Brief Temporoparietal ECT - Brief Pulse Temporoparietal ECT

Active comparator: Ultrabrief Temporoparietal ECT - Ultrabrief Pulse Temporoparietal ECT

Active comparator: Brief Frontoparietal ECT - Brief Pulse Frontoparietal ECT

Active comparator: Ultrabrief Frontoparietal ECT - Ultrabrief Pulse Frontoparietal ECT


Treatment: Surgery: Brief Temporoparietal ECT
Electroconvulsive Therapy (Brief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.

Treatment: Surgery: Ultrabrief Temporoparietal ECT
Electroconvulsive Therapy (Ultrabrief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.

Treatment: Surgery: Brief Frontoparietal ECT
Electroconvulsive Therapy (Brief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.

Treatment: Surgery: Ultrabrief Frontoparietal ECT
Electroconvulsive Therapy (Ultrabrief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HVLT-R
Timepoint [1] 0 0
Approximately 30 min after ECT treatment
Primary outcome [2] 0 0
BVMT-R
Timepoint [2] 0 0
Approximately 30 min after ECT treatment

Eligibility
Key inclusion criteria
* Aged =18 years; right-handed
* DSM-5 Major Depressive Episode
* Prescribed with a course of ECT
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Diagnosis (as defined by DSM-V) of psychotic disorder (apart from Major Depressive Episode with Psychotic features), current drug or alcohol abuse or dependence;
* ECT treatments in last 3 months from a prior course of ECT;
* Score <23 on the Montreal Cognitive Assessment Battery (MoCA);
* Past or current neurological illness or injury, medical illness which may significantly affect neuropsychological function;
* Inability to give informed consent or comply with study procedures; or
* Not having worked or studied in an English speaking background (to ensure validity of neuropsychological testing).
* Not be claustrophobic (if having an MRI brain scan).
* Not have any metal in your head or body (if having an MRI brain scan).
* Likely non response to RUL forms of ECT, as indicated by past non response to RUL ECT

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
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/06/2022
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Wesley Hospital Kogarah - Sydney
Recruitment postcode(s) [1] 0 0
2217 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Wesley Mission
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will generate new information on how to optimise brain targets with ECT stimulation.
Trial website
https://clinicaltrials.gov/study/NCT03297411
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Colleen Loo, MBBS
Address 0 0
The University of New South Wales
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Feng Lin, MD
Address 0 0
Country 0 0
Phone 0 0
+612 9382 8318
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03297411