Major Depressive EpisodeRAFT-ECTNCT05402657
The RAFT ECT Study
A study testing Frontoparietal Ultrabrief Right Unilateral (UBRUL-FP) electroconvulsive therapy and Temporoparietal Ultrabrief Right Unilateral (UBRUL-TP) electroconvulsive therapy in people with Major Depressive Episode, run by The George Institute at 7 sites in 2 countries.
Trial summary
Severe depression is devastating for those affected and is often associated with significant risk of suicide. Electroconvulsive therapy (ECT) is a highly effective acute treatment for severe depression, but its use and acceptability are limited by cognitive side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Episode
- What is being tested?
- Frontoparietal Ultrabrief Right Unilateral (UBRUL-FP) electroconvulsive therapy and Temporoparietal Ultrabrief Right Unilateral (UBRUL-TP) electroconvulsive therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 22 Mar 2023to 13 Feb 2026
- Phase
- Interventional
- 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
- DSM-5 diagnosis* of major depressive episode (unipolar or bipolar)
- HRSD-17 score ≥ 17 at Screening
- At least 18 years old
- Able to tolerate washout of prohibited medications and restriction on benzodiazepine dosage, as determined by patient's own treating psychiatrist.
- ECT indicated for treatment of depression, as determined by own treating referring psychiatrist and confirmed by research evaluations (e.g., diagnosis of depression)
- Willing and able to participate in research and comply with study requirements
- Sufficient proficiency in spoken English to ensure validity of neuropsychological testing (e.g., worked or studied in an English-speaking context or equivalent)
Who cannot join
- History of schizophrenia, schizoaffective disorder, other [non-mood disorder] psychosis, or rapid cycling bipolar disorder (DSM-5 diagnoses*)
- Current manic episode, hypomanic episode, or major depressive episode with mixed features (DSM-5 diagnoses*)
- Alcohol or substance use disorder (other than caffeine or nicotine) present in the past month, or is likely to be present during the 24-week study period as determined by study physician evaluation
- Diagnosis of amnestic disorder, dementia, delirium, or epilepsy, as determined by study physician evaluation and medical history
- Central nervous system disease or brain injury that has resulted in significant cognitive impact, as determined by study physician evaluation and medical history
- Serious or unstable medical condition, as determined by study physician evaluation and medical history
Show all 14Show fewer
- If female of childbearing potential: a) pregnancy as determined by pregnancy urine screen
- Completed an acute course of ECT during the past 2 months, as determined by treatment history
- Received any ECT during the past 2 weeks
- Failed an adequate course of ECT (i.e., 8 ECT treatments ) in the current depressive episode
- Patients who are prisoners, and those who lack capacity to make medical decisions (as judged by their own treating psychiatrist)
- Currently enrolled in another interventional clinical trial
- Currently using another investigational device or product
- DSM-5 psychiatric diagnoses will be assessed and confirmed using the Mini International Neuropsychiatric Interview (MINI; Sheehan et al., 1998) Version 7.0.2 for DSM-5, administered by research team members.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Australia4 sites
Gold Coast University Hospital (GCUH)
Gold Coast, Queensland, 4215
Ramsay Clinic Albert Road
Melbourne, Victoria, 3004
Ramsay Clinic Northside
Sydney, New South Wales, 2065
Ramsay Clinic Lakeside
Warners Bay, New South Wales, 2282
United States3 sites
Emory University
Atlanta, Georgia, 30322
Medical College of Georgia, Augusta University
Augusta, Georgia, 30912
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: The Randomised Controlled Trial of Frontoparietal and Temporoparietal Electroconvulsive Therapy (ECT) for Severe Depression: The RAFT ECT Study
Severe depression is devastating for those affected and is often associated with significant risk of suicide. Electroconvulsive therapy (ECT) is a highly effective acute treatment for severe depression, but its use and acceptability are limited by cognitive side effects. Of these, retrograde memory loss is most concerning, and can be long-term. The introduction of ultrabrief right unilateral (UBRUL) ECT into clinical practice has been an important step in reducing the risk of memory impairment, but significant deficits still occur.
A new form of UBRUL ECT which utilises a Frontoparietal electrode placement represents a further development. Preliminary data suggest that Frontoparietal UBRUL has good efficacy and less cognitive side effects than UBRUL given using the conventional Temporoparietal electrode placement. Designed as a pivotal trial, this protocol will be the first RCT comparing these two forms of ECT, producing the rigorous efficacy and safety data required to change clinical practice/policy.
This is a multicentre, parallel group RCT with 1:1 allocation ratio between Frontoparietal (intervention) and Temporoparietal (comparator) forms of UBRUL ECT. Participation will involve receiving randomised acute ECT under blinded conditions during the randomised acute treatment period (typically around 4 weeks), then completion of a 24-week follow-up period which commences after the cessation of all acute ECT. The study protocol aims to provide 12 randomised acute ECT treatments, though the number of treatments (and hence the length of the randomised acute treatment period) can be adjusted by the participant's own treating/admitting psychiatrist according to their clinical judgement.
- Conditions
- Major Depressive Episode
- Being tested
- Frontoparietal Ultrabrief Right Unilateral (UBRUL-FP) electroconvulsive therapy, Temporoparietal Ultrabrief Right Unilateral (UBRUL-TP) electroconvulsive therapy
- Keywords
- Severe depression, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major, Memory, Electroconvulsive therapy, Randomised clinical trial
- Medical subject headings
- Depression, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frontoparietal Ultrabrief Right Unilateral (UBRUL-FP) electroconvulsive therapyProcedure or surgery
UBRUL-FP involves ultrabrief right unilateral ECT delivered using a novel frontoparietal montage, where the anterior electrode is shifted frontally to a position above the midpoint of the right eye to avoid temporal lobe stimulation (and reduce memory side effects). UBRUL-FP will be delivered using standard ECT devices.
Temporoparietal Ultrabrief Right Unilateral (UBRUL-TP) electroconvulsive therapyProcedure or surgery
UBRUL-TP is the standard form of ultrabrief right unilateral ECT, using the conventional temporoparietal (d'Elia) electrode placement, where the anterior electrode is placed over the right temporal lobe. UBRUL-TP will be delivered using standard ECT devices.
| Study group | Role | What they receive |
|---|---|---|
| Frontoparietal ECT Group | Experimental | Participants will receive ultrabrief right unilateral ECT with a frontoparietal placement of ECT electrodes. Receives: Procedure: Frontoparietal Ultrabrief Right Unilateral (UBRUL-FP) electroconvulsive therapy |
| Temporoparietal ECT Group | Active comparator | Participants will receive ultrabrief right unilateral ECT with the conventional temporoparietal placement of ECT electrodes. Receives: Procedure: Temporoparietal Ultrabrief Right Unilateral (UBRUL-TP) electroconvulsive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17
The Hamilton Rating Scale for Depression-17 has a range of 0-52. Lower scores represent mild depression to no depression at all.
Measured: From baseline to end of randomized acute treatment (typically 4 weeks)
Secondary outcomes (13)
Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17
The Hamilton Rating Scale for Depression-17 has a range of 0-52. Lower scores represent mild depression to no depression at all.
Measured: From end of acute ECT treatment up to 24-week follow-up
Autobiographical Memory Interview-Short Form (AMI-SF) Consistency Scores
In the Autobiographical Memory Interview-Short Form, participants are graded on the consistency of their answers between baseline and subsequent time-points. The maximum consistency score is 100 percent, with lower percentages representing increasing inconsistency in retrospective autobiographical memory function.
Measured: From Baseline to end of randomized acute treatment (typically 4 weeks)
Clinical Global Impression-Severity (CGI-S)
The Clinical Global Impression-Severity measure is a 7-point scale where a clinician rates the severity of a patient's illness in comparison to the clinician's experience with patients who have the same diagnosis. The ratings range from 1 indicating normal, not at all ill to 7 suggesting they are among the most extremely ill patients.
Measured: From baseline to end of randomized acute treatment (typically 4 weeks)
Clinical Global Impression-Improvement (CGI-I)
The Clinical Global Impression-Improvement is a measure where a clinician assesses how much the patient's illness has improved or worsened in comparison to baseline. The "improved" version being used in this trial (Kadouri, Corruble \& Falissard, 2007) is a 13-point scale with ratings which range from 6 ('ideal improvement') to -6 (maximum deterioration).
Measured: Through the randomized acute ECT treatment period (typically 4 weeks)
Suicidality score
Assessed by examining scores on item 3 (suicidality) of the Hamilton Rating Scale for Depression (which range from 0 to 4, where higher scores indicate more severe and/or persistent suicidality) and scores on the suicidal ideation subscale of the Columbia
Measured: From baseline to end of randomized acute treatment (typically 4 weeks)
Post ECT reorientation time
Post ECT reorientation time is the time taken to recover orientation immediately after ECT in randomised treatment phase.
Measured: After ECT sessions 3 and 6, which typically occur at the end of week 1 and week 2 in the randomised acute treatment phase.
Change in mean neuropsychological function
Assessed by a cognitive test battery.
Measured: From baseline to end of randomized acute treatment (typically 4 weeks)
Mental Health Questionnaire-14 (MHQ-14)
The Mental Health Questionnaire-14 is a self-report quality of life instrument consisting of the mental health component of the Medical Outcomes Study questionnaire. This patient self-report measure contains 14 items in total, addressing symptoms of fatigue, anxiety and depression, and the impact of these symptoms on functioning. Scores on this measure range from 0 to 100, where higher scores indicate better quality of life.
Measured: From baseline to end of randomized acute treatment (typically 4 weeks)
Number of responders
Response is defined as a 50 percent reduction in depression severity from baseline, assessed using the Hamilton Rating Scale for Depression-17
Measured: From baseline to End of Randomized Acute Treatment (typically 4 weeks)
Number of remitters
Remission is defined as a score of ≤ 7 on the Hamilton Rating Scale for Depression-17.
Measured: From baseline to end of randomized acute treatment (typically 4 weeks)
Number of participants switched from randomized treatment to another form of acute ECT
Number of participants switched from randomized treatment to another form of acute ECT after receiving at least 8 randomized ECT.
Measured: After at least 8 randomized ECT treatments (typically after 3 weeks).
Number of randomized ECT treatments given over the Acute Study Treatment Phase (RCT)
Number of randomized acute ECT treatments received by participants during the Acute Study Treatment Phase (RCT), compared between the groups.
Measured: From baseline to End of Randomized Acute Treatment (typically 4 weeks)
Occurrence of adverse events and serious adverse events
Occurrence of adverse events (AEs) and serious adverse events (SAEs) compared between the groups, based on treating them as binary outcomes (no/yes, e.g., whether participants experienced any given side effect/adverse event at least once) and as count outcomes (number of occurrences).
Measured: From baseline and up to 24-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start22 Mar 2023
- Primary completion19 Aug 2025
- Study completion13 Feb 2026
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 Major Depressive EpisodeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Ramsay Clinic Albert Road, Australia, Ramsay Clinic Lakeside, Australia, Ramsay Clinic Northside, Australia, Gold Coast Hospital and Health Service, Augusta University, Medical University of South Carolina, The University of New South Wales, Emory University
- Responsible party
- Sponsor
- Investigators
- Colleen Loo, Principal investigator, University of New South WalesAnthony Rodgers, Study director, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05402657
- Sponsor's protocol ID
- X22-0018
- Other IDs
- APP1159769, RG180233
- Acronym
- RAFT-ECT
- Status last verified
- Mar 2026
- First submitted
- 5 May 2022
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared upon request to the data custodian, subject to approval from the Trial Steering Committee and signing of data transfer agreements.
Publications
Loo C, Barreiros AR, Martin D, Dong V, George MS, McCall WV, Sarma S, Hopwood M, Weiss A, Bull M, Tuneu CM, Alonzo A, Hadzi-Pavlovic D, Rodgers A, Sahlem GL, Harvey AJ, Haldane K, Brettell L, Fitzgerald PB, Dokos S, Sackeim H. A Randomized Controlled Trial of Ultrabrief Right Unilateral ECT With Frontoparietal Versus Temporoparietal Electrode Placement for Severe Depression-The RAFT ECT Trial. J ECT. 2024 Dec 1;40(4):229-231. doi: 10.1097/YCT.0000000000001018. Epub 2024 Jul 5. No abstract available.
PubMed 38968425
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomised Controlled Trial of Frontoparietal and Temporoparietal Electroconvulsive Therapy (ECT) for Severe Depression: The RAFT ECT Study
- ClinicalTrials.gov ID
- NCT05402657
- Acronym / sponsor ID
- RAFT-ECT / X22-0018
- Conditions
- Major Depressive Episode
- Keywords
- Severe depression, Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major, Memory, Electroconvulsive therapy, Randomised clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, Ramsay Clinic Albert Road, Australia, Ramsay Clinic Lakeside, Australia, Ramsay Clinic Northside, Australia, Gold Coast Hospital and Health Service, Augusta University, Medical University of South Carolina, The University of New South Wales, Emory University
- Study start
- 22 Mar 2023 (actual)
- Primary completion
- 19 Aug 2025 (actual)
- Study completion
- 13 Feb 2026 (actual)
- First posted
- 2 Jun 2022 (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.
Severe depression is devastating for those affected and is often associated with significant risk of suicide. Electroconvulsive therapy (ECT) is a highly effective acute treatment for severe depression, but its use and acceptability are limited by cognitive side effects. Of these, retrograde memory loss is most concerning, and can be long-term. The introduction of ultrabrief right unilateral (UBRUL) ECT into clinical practice has been an important step in reducing the risk of memory impairment, but significant deficits still occur.
A new form of UBRUL ECT which utilises a Frontoparietal electrode placement represents a further development. Preliminary data suggest that Frontoparietal UBRUL has good efficacy and less cognitive side effects than UBRUL given using the conventional Temporoparietal electrode placement. Designed as a pivotal trial, this protocol will be the first RCT comparing these two forms of ECT, producing the rigorous efficacy and safety data required to change clinical practice/policy.
This is a multicentre, parallel group RCT with 1:1 allocation ratio between Frontoparietal (intervention) and Temporoparietal (comparator) forms of UBRUL ECT. Participation will involve receiving randomised acute ECT under blinded conditions during the randomised acute treatment period (typically around 4 weeks), then completion of a 24-week follow-up period which commences after the cessation of all acute ECT. The study protocol aims to provide 12 randomised acute ECT treatments, though the number of treatments (and hence the length of the randomised acute treatment period) can be adjusted by the participant's own treating/admitting psychiatrist according to their clinical judgement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frontoparietal ECT Group | Experimental | Procedure: Frontoparietal Ultrabrief Right Unilateral (UBRUL-FP) electroconvulsive therapyParticipants will receive ultrabrief right unilateral ECT with a frontoparietal placement of ECT electrodes. |
| Temporoparietal ECT Group | Active comparator | Procedure: Temporoparietal Ultrabrief Right Unilateral (UBRUL-TP) electroconvulsive therapyParticipants will receive ultrabrief right unilateral ECT with the conventional temporoparietal placement of ECT electrodes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- DSM-5 diagnosis* of major depressive episode (unipolar or bipolar)
- HRSD-17 score ≥ 17 at Screening
- At least 18 years old
- Able to tolerate washout of prohibited medications and restriction on benzodiazepine dosage, as determined by patient's own treating psychiatrist.
- ECT indicated for treatment of depression, as determined by own treating referring psychiatrist and confirmed by research evaluations (e.g., diagnosis of depression)
Key exclusion criteria (14 listed)
- History of schizophrenia, schizoaffective disorder, other [non-mood disorder] psychosis, or rapid cycling bipolar disorder (DSM-5 diagnoses*)
- Current manic episode, hypomanic episode, or major depressive episode with mixed features (DSM-5 diagnoses*)
- Alcohol or substance use disorder (other than caffeine or nicotine) present in the past month, or is likely to be present during the 24-week study period as determined by study physician evaluation
- Diagnosis of amnestic disorder, dementia, delirium, or epilepsy, as determined by study physician evaluation and medical history
- Central nervous system disease or brain injury that has resulted in significant cognitive impact, as determined by study physician evaluation and medical history
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 |
|---|---|---|
| Frontoparietal Ultrabrief Right Unilateral (UBRUL-FP) electroconvulsive therapyUBRUL-FP involves ultrabrief right unilateral ECT delivered using a novel frontoparietal montage, where the anterior electrode is shifted frontally to a position above the midpoint of the right eye to avoid temporal lobe stimulation (and reduce memory side effects). UBRUL-FP will be delivered using standard ECT devices. | Procedure or surgery | Frontoparietal ECT Group |
| Temporoparietal Ultrabrief Right Unilateral (UBRUL-TP) electroconvulsive therapyUBRUL-TP is the standard form of ultrabrief right unilateral ECT, using the conventional temporoparietal (d'Elia) electrode placement, where the anterior electrode is placed over the right temporal lobe. UBRUL-TP will be delivered using standard ECT devices. | Procedure or surgery | Temporoparietal ECT Group |
Primary outcome
Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17
Time frame: From baseline to end of randomized acute treatment (typically 4 weeks)
The Hamilton Rating Scale for Depression-17 has a range of 0-52. Lower scores represent mild depression to no depression at all.
13 secondary outcomes
Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17
Time frame: From end of acute ECT treatment up to 24-week follow-up
Autobiographical Memory Interview-Short Form (AMI-SF) Consistency Scores
Time frame: From Baseline to end of randomized acute treatment (typically 4 weeks)
Clinical Global Impression-Severity (CGI-S)
Time frame: From baseline to end of randomized acute treatment (typically 4 weeks)
Clinical Global Impression-Improvement (CGI-I)
Time frame: Through the randomized acute ECT treatment period (typically 4 weeks)
Suicidality score
Time frame: From baseline to end of randomized acute treatment (typically 4 weeks)
Post ECT reorientation time
Time frame: After ECT sessions 3 and 6, which typically occur at the end of week 1 and week 2 in the randomised acute treatment phase.
Change in mean neuropsychological function
Time frame: From baseline to end of randomized acute treatment (typically 4 weeks)
Mental Health Questionnaire-14 (MHQ-14)
Time frame: From baseline to end of randomized acute treatment (typically 4 weeks)
Number of responders
Time frame: From baseline to End of Randomized Acute Treatment (typically 4 weeks)
Number of remitters
Time frame: From baseline to end of randomized acute treatment (typically 4 weeks)
Number of participants switched from randomized treatment to another form of acute ECT
Time frame: After at least 8 randomized ECT treatments (typically after 3 weeks).
Number of randomized ECT treatments given over the Acute Study Treatment Phase (RCT)
Time frame: From baseline to End of Randomized Acute Treatment (typically 4 weeks)
Occurrence of adverse events and serious adverse events
Time frame: From baseline and up to 24-week follow-up
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 13 Mar 2026.
- Derived from this study: PubMed 38968425Loo C, Barreiros AR, Martin D, Dong V, George MS, McCall WV, Sarma S, Hopwood M, Weiss A, Bull M, Tuneu CM, Alonzo A, Hadzi-Pavlovic D, Rodgers A, Sahlem GL, Harvey AJ, Haldane K, Brettell L, Fitzgerald PB, Dokos S, Sackeim H. A Randomized Controlled Trial of Ultrabrief Right Unilateral ECT With Frontoparietal Versus Temporoparietal Electrode Placement for Severe Depression-The RAFT ECT Trial. J ECT. 2024 Dec 1;40(4):229-231. doi: 10.1097/YCT.0000000000001018. Epub 2024 Jul 5. No abstract available.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared upon request to the data custodian, subject to approval from the Trial Steering Committee and signing of data transfer agreements.
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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 principal investigator
University of New South Wales
Anthony Rodgers study director
The George Institute
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Frontoparietal Ultrabrief Right Unilateral (UBRUL-FP) electroconvulsive therapy and Temporoparietal Ultrabrief Right Unilateral (UBRUL-TP) electroconvulsive therapy in people with Major Depressive Episode, run by The George Institute at 7 sites in 2 countries.
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 7 inclusion and 14 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 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, United States. 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.
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?
Change in Depressive Symptoms as Assessed by Hamilton Rating Scale for Depression-17 (time frame: From baseline to end of randomized acute treatment (typically 4 weeks)). 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 NCT05402657, 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 13 Mar 2026.