DepressionPhase 2NCT03297411
Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling
A Phase 2 study testing Brief Temporoparietal ECT, Ultrabrief Temporoparietal ECT and Brief Frontoparietal ECT in people with Depression, run by The University of New South Wales at 1 site in Australia.
Trial summary
This study will generate new information on how to optimise brain targets with ECT stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Brief Temporoparietal ECT, Ultrabrief Temporoparietal ECT and Brief Frontoparietal ECT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- 10 Oct 2017to 22 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years; right-handed
- DSM-5 Major Depressive Episode
- Prescribed with a course of ECT
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
Colleen Loo, MBBS contact
Australia1 site, 1 recruiting
- Recruiting
Wesley Hospital Kogarah
Sydney, New South Wales, 2217
Feng Lin, MD, +612 9383 8318
About this study
This study will generate new information on how to optimise brain targets with ECT stimulation.
Read the detailed description
This study will differentiate the brain regions which are related to the effectiveness of electroconvulsive therapy (ECT) as a treatment, from the brain regions associated with memory impairment, with ECT stimulation. This will be done by 1) testing effects on memory of 4 different forms of ECT, which stimulate the brain differently; 2) in a subset of participants, use computer modelling to assess the pattern of brain stimulation with the 4 forms of ECT, and match these results to memory outcomes.
- Conditions
- Depression
- Being tested
- Brief Temporoparietal ECT, Ultrabrief Temporoparietal ECT, Brief Frontoparietal ECT, Ultrabrief Frontoparietal ECT
- Keywords
- electroconvulsive therapy, computer modelling
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Temporoparietal ECTProcedure or surgery
Electroconvulsive Therapy (Brief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
Ultrabrief Temporoparietal ECTProcedure or surgery
Electroconvulsive Therapy (Ultrabrief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
Brief Frontoparietal ECTProcedure or surgery
Electroconvulsive Therapy (Brief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
Ultrabrief Frontoparietal ECTProcedure or surgery
Electroconvulsive Therapy (Ultrabrief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
| Study group | Role | What they receive |
|---|---|---|
| Brief Temporoparietal ECT | Active comparator | Brief Pulse Temporoparietal ECT Receives: Procedure: Brief Temporoparietal ECT |
| Ultrabrief Temporoparietal ECT | Active comparator | Ultrabrief Pulse Temporoparietal ECT Receives: Procedure: Ultrabrief Temporoparietal ECT |
| Brief Frontoparietal ECT | Active comparator | Brief Pulse Frontoparietal ECT Receives: Procedure: Brief Frontoparietal ECT |
| Ultrabrief Frontoparietal ECT | Active comparator | Ultrabrief Pulse Frontoparietal ECT Receives: Procedure: Ultrabrief Frontoparietal ECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
HVLT-R
Hopkins Verbal Learning Test-Revised
Measured: Approximately 30 min after ECT treatment
BVMT-R
Brief Visual Memory Test-Revised
Measured: Approximately 30 min after ECT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start10 Oct 2017
- Primary completion22 Jun 2022 (estimated)
- Study completion22 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Collaborators
- Wesley Mission
- Responsible party
- Principal investigator, Colleen Loo, The University of New South Wales
- Investigators
- Colleen Loo, MBBS, Principal investigator, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297411
- Sponsor's protocol ID
- HC17286
- Status last verified
- May 2018
- First submitted
- 14 Sep 2017
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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. 2026 Mar 1;42(1):63-69. doi: 10.1097/YCT.0000000000001135. Epub 2025 Apr 3.
PubMed 40184538
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling
- ClinicalTrials.gov ID
- NCT03297411
- Acronym / sponsor ID
- HC17286
- Conditions
- Depression
- Keywords
- electroconvulsive therapy, computer modelling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- Wesley Mission
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 22 Jun 2022 (estimated)
- Study completion
- 22 Jun 2022 (estimated)
- First posted
- 29 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will generate new information on how to optimise brain targets with ECT stimulation.
Detailed description
This study will differentiate the brain regions which are related to the effectiveness of electroconvulsive therapy (ECT) as a treatment, from the brain regions associated with memory impairment, with ECT stimulation. This will be done by 1) testing effects on memory of 4 different forms of ECT, which stimulate the brain differently; 2) in a subset of participants, use computer modelling to assess the pattern of brain stimulation with the 4 forms of ECT, and match these results to memory outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Brief Temporoparietal ECT | Active comparator | Procedure: Brief Temporoparietal ECTBrief Pulse Temporoparietal ECT |
| Ultrabrief Temporoparietal ECT | Active comparator | Procedure: Ultrabrief Temporoparietal ECTUltrabrief Pulse Temporoparietal ECT |
| Brief Frontoparietal ECT | Active comparator | Procedure: Brief Frontoparietal ECTBrief Pulse Frontoparietal ECT |
| Ultrabrief Frontoparietal ECT | Active comparator | Procedure: Ultrabrief Frontoparietal ECTUltrabrief Pulse Frontoparietal ECT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged ≥18 years; right-handed
- DSM-5 Major Depressive Episode
- Prescribed with a course of ECT
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief Temporoparietal ECTElectroconvulsive Therapy (Brief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements. | Procedure or surgery | Brief Temporoparietal ECT |
| Ultrabrief Temporoparietal ECTElectroconvulsive Therapy (Ultrabrief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements. | Procedure or surgery | Ultrabrief Temporoparietal ECT |
| Brief Frontoparietal ECTElectroconvulsive Therapy (Brief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements. | Procedure or surgery | Brief Frontoparietal ECT |
| Ultrabrief Frontoparietal ECTElectroconvulsive Therapy (Ultrabrief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements. | Procedure or surgery | Ultrabrief Frontoparietal ECT |
Primary outcome
HVLT-R
Time frame: Approximately 30 min after ECT treatment
Hopkins Verbal Learning Test-Revised
BVMT-R
Time frame: Approximately 30 min after ECT treatment
Brief Visual Memory Test-Revised
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Derived from this study: PubMed 40184538Martin 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. 2026 Mar 1;42(1):63-69. doi: 10.1097/YCT.0000000000001135. Epub 2025 Apr 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen Loo, MBBS contact
Colleen Loo, MBBS principal investigator
The University of New South Wales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Brief Temporoparietal ECT, Ultrabrief Temporoparietal ECT and Brief Frontoparietal ECT in people with Depression, run by The University of New South Wales at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Feng Lin, MD (+612 9382 8318, feng.lin@student.unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HVLT-R (time frame: Approximately 30 min after ECT treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03297411, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.