Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling

NCT03297411 | Unknown Phase 2

• 1 other identifier: HC17286
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study will generate new information on how to optimise brain targets with ECT stimulation.

Conditions

Depression

Keywords

electroconvulsive therapy; computer modelling

Outcome Measures

Primary Outcomes (2)

• HVLT-R

  Hopkins Verbal Learning Test-Revised

  Approximately 30 min after ECT treatment

• BVMT-R

  Brief Visual Memory Test-Revised

  Approximately 30 min after ECT treatment

Study Arms (4)

Brief Temporoparietal ECT

ACTIVE COMPARATOR

Brief Pulse Temporoparietal ECT

Procedure: Brief Temporoparietal ECT

Ultrabrief Temporoparietal ECT

ACTIVE COMPARATOR

Ultrabrief Pulse Temporoparietal ECT

Procedure: Ultrabrief Temporoparietal ECT

Brief Frontoparietal ECT

ACTIVE COMPARATOR

Brief Pulse Frontoparietal ECT

Procedure: Brief Frontoparietal ECT

Ultrabrief Frontoparietal ECT

ACTIVE COMPARATOR

Ultrabrief Pulse Frontoparietal ECT

Procedure: Ultrabrief Frontoparietal ECT

Interventions

Brief Temporoparietal ECT PROCEDURE

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

Brief Temporoparietal ECT

Ultrabrief Temporoparietal ECT PROCEDURE

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

Ultrabrief Temporoparietal ECT

Brief Frontoparietal ECT PROCEDURE

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

Brief Frontoparietal ECT

Ultrabrief Frontoparietal ECT PROCEDURE

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

Ultrabrief Frontoparietal ECT

Eligibility Criteria

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

You may qualify if:

• Aged ≥18 years; right-handed
• DSM-5 Major Depressive Episode
• Prescribed with a course of ECT

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of New South Wales: lead
• Wesley Mission: collaborator

Study Sites (1)

Wesley Hospital Kogarah

Sydney, New South Wales, 2217, Australia

RECRUITING

Related Publications (1)

• Martin DM, Alduraywish A, Bakir AA, Dokos PhD S, Bakouri M, Bai S, Sackeim HA, Loo CK. A Computational Modeling Study of Focal Electrically Administered Seizure Therapy and Frontoparietal Electroconvulsive Therapy. J ECT. 2025 Apr 3. doi: 10.1097/YCT.0000000000001135. Online ahead of print.

  PMID: 40184538 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Colleen Loo, MBBS

  The University of New South Wales

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Lin, MD

CONTACT

+612 9382 8318; feng.lin@student.unsw.edu.au

Colleen Loo, MBBS

CONTACT

+612 9113 2039

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Both participants and the outcome assessor will be blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Each participant will be randomly allocated to a sequence of treatments using designs for crossover studies with fewer periods (3) than treatments (4) involving two sets of ECT electrode placements and two sets of pulse width.

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 29, 2017
• Study Start: October 10, 2017
• Primary Completion: June 22, 2022
• Study Completion: June 22, 2022
• Last Updated: May 16, 2018

Record last verified: 2018-05

Locations

AU (1)