DepressionPhase 3NCT03105245
Understanding How Anaesthesia Affects ECT Outcomes
A Phase 3 study testing Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone) in people with Depression, run by The University of New South Wales at 1 site in Australia.
Trial summary
This study will examine how anaesthetic technique affects ECT outcomes. Specifically, the investigators will examine how: 1) the time interval between anaesthetic and ECT stimulus, and 2) the ventilation rate before ECT stimulus, impacts on the quality of the EEG (this is a recording of brain activity during ECT and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Mar 2017to 15 Mar 2019
- Phase
- Phase 3
- 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
- Patients treated with a course of ECT
Who cannot join
- Use of non-standard anaesthetic agents in ECT (e.g. ketamine)
Trial locations and contacts
1 site in 1 country.
About this study
This study will examine how anaesthetic technique affects ECT outcomes. Specifically, the investigators will examine how: 1) the time interval between anaesthetic and ECT stimulus, and 2) the ventilation rate before ECT stimulus, impacts on the quality of the EEG (this is a recording of brain activity during ECT and is used to judge the quality of a seizure and to guide individual patient dosing).
Read the detailed description
This study aims to examine how the time interval between administration of anaesthetic agent and ECT stimulus delivery impacts upon measures of EEG quality (seizure quality).
- Conditions
- Depression
- Being tested
- Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)
- Keywords
- electroconvulsive therapy, anaesthesia
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)Other
The intervention in this study is the time interval between anaesthetic administration and ECT stimulus
| Study group | Role | What they receive |
|---|---|---|
| Short time interval + Normal ventilation | Active comparator | Not described Receives: Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone) |
| Short time interval + Hyperventilation | Active comparator | Not described Receives: Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone) |
| Long time interval + Normal ventilation | Active comparator | Not described Receives: Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone) |
| Long time interval + Hyperventilation | Active comparator | Not described Receives: Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG Seizure Quality Rating using the EEG Seizure Quality Rating Sheet utilised by MacPherson et al
EEG quality will be rated manually for each ECT treatment undertaken by a participant until the conclusion of their ECT course. This rating will be done using the EEG Seizure Quality Rating Sheet utilised by MacPherson et al - low dose lignocaine added to propofol does not attenuate the response to electroconvulsive therapy; Journal of Affective Disorders, 2010; 126: 330-333
Measured: Outcome measures will be collected immediately after each ECT treatment from the first treatment until the end of the ECT course, an estimated total of four to six weeks for most participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start15 Mar 2017
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will receive all four treatment conditions in randomly allocated sequence during their ECT course. That is, participants will receive either short or long anaesthetic-ECT stimulus time interval treatments, and normal or hyperventilation treatments - this results in four possible combinations, which individual participants will cycle through in random order during their ECT course (e.g. short-hyperventilation, long-normal ventilation, short-normal ventilation, long-hyperventilation).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
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
- NCT03105245
- Sponsor's protocol ID
- HREC16952
- Status last verified
- Mar 2023
- First submitted
- 27 Feb 2017
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding How Anaesthesia Affects ECT Outcomes
- ClinicalTrials.gov ID
- NCT03105245
- Acronym / sponsor ID
- HREC16952
- Conditions
- Depression
- Keywords
- electroconvulsive therapy, anaesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Collaborators
- Wesley Mission
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 7 Apr 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 examine how anaesthetic technique affects ECT outcomes. Specifically, the investigators will examine how: 1) the time interval between anaesthetic and ECT stimulus, and 2) the ventilation rate before ECT stimulus, impacts on the quality of the EEG (this is a recording of brain activity during ECT and is used to judge the quality of a seizure and to guide individual patient dosing).
Detailed description
This study aims to examine how the time interval between administration of anaesthetic agent and ECT stimulus delivery impacts upon measures of EEG quality (seizure quality).
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 receive all four treatment conditions in randomly allocated sequence during their ECT course. That is, participants will receive either short or long anaesthetic-ECT stimulus time interval treatments, and normal or hyperventilation treatments - this results in four possible combinations, which individual participants will cycle through in random order during their ECT course (e.g. short-hyperventilation, long-normal ventilation, short-normal ventilation, long-hyperventilation).
| Arm | Type | Receives |
|---|---|---|
| Short time interval + Normal ventilation | Active comparator | Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone) |
| Short time interval + Hyperventilation | Active comparator | Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone) |
| Long time interval + Normal ventilation | Active comparator | Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone) |
| Long time interval + Hyperventilation | Active comparator | Other: Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients treated with a course of ECT
Key exclusion criteria (1 listed)
- Use of non-standard anaesthetic agents in ECT (e.g. ketamine)
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 |
|---|---|---|
| Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)The intervention in this study is the time interval between anaesthetic administration and ECT stimulus | Other | Long time interval + Hyperventilation, Long time interval + Normal ventilation, Short time interval + Hyperventilation, Short time interval + Normal ventilation |
Primary outcome
EEG Seizure Quality Rating using the EEG Seizure Quality Rating Sheet utilised by MacPherson et al
Time frame: Outcome measures will be collected immediately after each ECT treatment from the first treatment until the end of the ECT course, an estimated total of four to six weeks for most participants
EEG quality will be rated manually for each ECT treatment undertaken by a participant until the conclusion of their ECT course. This rating will be done using the EEG Seizure Quality Rating Sheet utilised by MacPherson et al - low dose lignocaine added to propofol does not attenuate the response to electroconvulsive therapy; Journal of Affective Disorders, 2010; 126: 330-333
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Individual participant dataSharing planned: No
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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 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 3 study testing Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone) 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Mar 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG Seizure Quality Rating using the EEG Seizure Quality Rating Sheet utilised by MacPherson et al (time frame: Outcome measures will be collected immediately after each ECT treatment from the first treatment until the end of the ECT course, an estimated total of four to six weeks for most participants). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2023.