Post-stroke DepressionNCT06912191
Investigating How the RECT Impacts Brain Functional States Through the ACC-cerebellar Loop
A study testing Left cerebellar TMS stimulation combined with the RECT task, Right cerebellar TMS stimulation combined with the RECT task and Midline cerebellar TMS stimulation combined with the RECT task in people with Post-stroke Depression, run by The Second Affiliated Hospital of Kunming Medical University.
Trial summary
Experiment1: Using a brain EEG-TMS combined system, researchers aim to investigate the impact of the rostral anterior cingulate cortexr (rACC)-engaging cognitive task (RECT) combined single-pulse TMS magnetic stimulation on theta neural oscillations in the medial frontal lobe. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-stroke Depression
- What is being tested?
- Left cerebellar TMS stimulation combined with the RECT task, Right cerebellar TMS stimulation combined with the RECT task and Midline cerebellar TMS stimulation combined with the RECT task
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2025to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Onset of stroke <6 months ago, or >6 months since the last stroke event;
- Age >=18 years and <85 years (as the probability of Vascular Cognitive Impairment increases above 85);
- Patients with damage in the middle cerebral artery territory;
- NIHSS >4 and <26;
- mRS score >=2;
- Completion of CT or MRI;
- No neurological or psychiatric disorders; no impairment of consciousness; able to comply with relevant treatments; no severe cognitive dysfunction (MMSE >=15);
- All participants are right-handed; Sign the informed consent form.
Who cannot join
- History of epilepsy or psychiatric disorders (including depression, anxiety, or schizophrenia);
- Severe comorbidities;
- History of medication use: benzodiazepines, baclofen, antidepressants;
- Non-compliance with the treatment plan;
- Acute-phase cerebral hemorrhage, acute infectious diseases;
- Severe suicidal tendencies in individuals with depression;
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- Individuals suffering from severe headaches, high blood pressure, malignant tumors, open wounds, vascular embolism, leukopenia, etc.;
- Severe alcohol abuse;
- History of cranial surgery, individuals with metal implants in the brain;
- Individuals with an implanted cardiac pacemaker;
- NIHSS >26, MMSE <15;
- Any disease likely to prevent the patient from surviving more than one month;
- Pregnant individuals.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Experiment1: Using a brain EEG-TMS combined system, researchers aim to investigate the impact of the rostral anterior cingulate cortexr (rACC)-engaging cognitive task (RECT) combined single-pulse TMS magnetic stimulation on theta neural oscillations in the medial frontal lobe. The study will be divided into 4 groups: the first group will receive left cerebellar single-pulse TMS stimulation combined with the RECT task, the second group will receive right cerebellar single-pulse TMS stimulation combined with the RECT task, the third group will receive midline cerebellar single-pulse TMS stimulation combined with the RECT task, and the fourth group will receive sham cerebellar single-pulse TMS stimulation combined with the RECT task. Divide the participants into groups of 15 people each, following a 1:1:1:1 ratio. Based on the above testing, the stimulus method that results in the most significant change in the midline of the frontal lobe will be identified.
Experiment 2: Based on the research from Experiment 1, the most significant approach affecting theta neural oscillations in the medial frontal gyrus will be identified. This stimulation protocol will be combined with left dorsolateral prefrontal cortex iTBS stimulation in Experiment 2. The research aim of Experiment 2 is to investigate the most effective stimulation method for enhancing midline theta neural oscillations in the frontal lobe, in combination with left dorsolateral prefrontal cortex iTBS, for the treatment of post-stroke depression patients. This study will include 40 post-stroke depressed patients, and each participant must meet the inclusion criteria. The first group of participants, consisting of 20 individuals, will receive the optimal combination intervention. The second group of participants will only receive iTBS stimulation, without any additional intervention strategies used in Experiment 1. Patients will undergo Hamilton Depression Scale assessment and resting state and task state EEG collection at baseline, one week after intervention, and two weeks after intervention.The primary outcome will be the Hamilton Depression Scale, with EEG-related data being analyzed as a secondary outcome. Task-oriented EEG detection will include both facial expression recognition paradigm and oddball experiment paradigm. Reaction time, accuracy, and completion status will be recorded simultaneously in the experiment. The experiment will record patients' tolerance and any adverse events that occur.
- Conditions
- Post-stroke Depression
- Being tested
- Left cerebellar TMS stimulation combined with the RECT task, Right cerebellar TMS stimulation combined with the RECT task, Midline cerebellar TMS stimulation combined with the RECT task, Sham cerebellar TMS stimulation combined with the RECT task, The best stimulation protocol combined with left dorsolateral prefrontal cortex iTBS
- Keywords
- EEG, ERP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left cerebellar TMS stimulation combined with the RECT taskOther
Also called RECT task, TMS
The first group will receive left cerebellar single-pulse TMS stimulation combined with the RECT task. RECT refers to rostral anterior cingulate cortexr (rACC)-engaging cognitive task. The theoretical basis of this task is that when subjects are in a state of focused attention, the power of theta neural oscillations in the midline of their frontal lobe will increase. By considering the features of post-stroke depression, this study combines the emotional recognition task with the RECT task. During each trial, individuals will view 4 faces consecutively, each displaying a different expression, and they will be required to memorize the sequence of expressions. Emoticons consist of joy, sorrow, and rage. After displaying four facial expressions, a brief text flowchart will appear. Participants need to check if the sequence reflected in the flowchart matches the order in which the four facial expressions appeared. If they match, click the left mouse button; if they do not match, click the
Right cerebellar TMS stimulation combined with the RECT taskOther
Also called RECT task, TMS
Right cerebellar single-pulse TMS stimulation combined with the RECT task
Midline cerebellar TMS stimulation combined with the RECT taskOther
Also called RECT task, TMS
Midline cerebellar single-pulse TMS stimulation combined with the RECT task
Sham cerebellar TMS stimulation combined with the RECT taskOther
Also called RECT task
Sham cerebellar single-pulse TMS stimulation combined with the RECT task, The TMS coil was placed at the cerebellar site but tilted 90° to prevent effective magnetic field penetration.
The best stimulation protocol combined with left dorsolateral prefrontal cortex iTBSOther
Also called left dorsolateral prefrontal cortex iTBS, RECT task, TMS
The optimal stimulation protocol determined in Experiment 1 combined with stimulation of the left dorsolateral prefrontal cortex.
Left dorsolateral prefrontal cortex iTBS stimulation, as well as sham TMS stimulation and sham RECT task.Other
Also called left dorsolateral prefrontal cortex iTBS
Subjects in the group underwent left dorsolateral prefrontal cortex iTBS stimulation, in addition to receiving sham TMS stimulation and participating in a sham RECT task. The sham RECT task involves having participants watch a continuous scroll of faces without needing to react.
Sham left dorsolateral prefrontal cortex iTBS stimulation, sham cerebellar TMS stimulation, and sham RECT task.Other
The participants in this group received sham left dorsolateral prefrontal cortex iTBS stimulation, sham cerebellar TMS stimulation, and sham RECT task.
| Study group | Role | What they receive |
|---|---|---|
| LC TMS combined with the RECT task (Experiment1) | Experimental | Left cerebellar single-pulse TMS stimulation combined with the RECT task Receives: Other: Left cerebellar TMS stimulation combined with the RECT task |
| RC TMS combined with the RECT task (Experiment1) | Experimental | Right cerebellar single-pulse TMS stimulation combined with the RECT task Receives: Other: Right cerebellar TMS stimulation combined with the RECT task |
| MC TMS combined with the RECT task (Experiment1) | Experimental | Midline cerebellar single-pulse TMS stimulation combined with the RECT task Receives: Other: Midline cerebellar TMS stimulation combined with the RECT task |
| Sham cerebellar single-pulse TMS stimulation combined with the RECT task (Experiment1) | Sham comparator | Sham cerebellar single-pulse TMS stimulation combined with the RECT task, The TMS coil was placed at the cerebellar site but tilted 90° to prevent effective magnetic field penetration. Receives: Other: Sham cerebellar TMS stimulation combined with the RECT task |
| Combined Stimulus Intervention group （Experiment 2） | Experimental | Combined iTBS stimulation of the dorsolateral prefrontal cortex and TMS of the cerebellum with the RECT task intervention group Receives: Other: The best stimulation protocol combined with left dorsolateral prefrontal cortex iTBS |
| iTBS treatment group（Experiment 2） | Experimental | The group of participants will receive left dorsolateral prefrontal cortex iTBS stimulation, as well as sham cerebellar TMS stimulation and sham RECT task. Receives: Other: Left dorsolateral prefrontal cortex iTBS stimulation, as well as sham TMS stimulation and sham RECT task. |
| Traditional treatment group（Experiment 2） | Sham comparator | The group of participants will receive sham left dorsolateral prefrontal cortex iTBS stimulation, sham cerebellar TMS stimulation, and sham RECT task. Receives: Other: Sham left dorsolateral prefrontal cortex iTBS stimulation, sham cerebellar TMS stimulation, and sham RECT task. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale，MADRS
This scale will be the primary outcome measure for Experiment 2. Montgomery-Asberg Depression Rating Scale，MADRS: Extreme depression: MADRS >35; Major depression: MADRS >30; Moderate depression: MADRS >22; Mild depression: MADRS >12; Remission stage: MADRS <12.
Measured: Day1
Electroencephalogram
EEG will be the main outcome measures for Experiment 1 and Experiment 2. EEG power in the delta, theta, alpha, beta band: the power spectral density (PSD) in unit^2/Hz Functional connectivity---Phase locking value (PLV): The value of PLV ranges from 0 to 1 Event related potentials in amplitude/μV
Measured: Day 1
Secondary outcomes (7)
Mini-mental state examination,MMSE
Mini-mental state examination,MMSE: A score of 27-30: normal; Score < 27: cognitive impairment.
Measured: Day 1
Montreal Cognitive Assessment, MoCA
Montreal Cognitive Assessment, MoCA: The total score of the scale is 30 points, and the test result shows that the normal value is ≥26 points.
Measured: Day 1
Hamilton Depression Scale，HAMD
Hamilton Depression Scale，HAMD: A total score of more than 35 May indicate severe depression.
Measured: Day 1
Hamilton Anxiety Scale，HAMA
Hamilton Anxiety Scale，HAMA: The total score ≥29, may be severe anxiety; ≥21 points, there must be obvious anxiety; ≥14 points, definitely have anxiety; More than 7 points, may have anxiety; If the score is less than 7, there is no anxiety symptom
Measured: Day 1
Quick Inventory of Depressive Symptomatology Self-Report, QIDS-SR16
Quick Inventory of Depressive Symptomatology Self-Report, QIDS-SR16: The total score is calculated on a scale of 0 to 27, with higher scores being associated with higher levels of depression.
Measured: Day 1
Response time
Recording their response times in seconds: The average reaction time of subjects in the facial expression recognition task to judge each facial expression picture.
Measured: Day 1
Accuracy rates
Recording their accuracy rates in % during the task: The average correct rate at which subjects judged each expression picture in the facial expression recognition task.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start30 Mar 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-stroke 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liqing Yao, The Second Affiliated Hospital of Kunming Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912191
- Sponsor's protocol ID
- Shen-PJ-Ke-2024-138
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 4 Apr 2025
- 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 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating How the RECT Impacts Brain Functional States Through the ACC-cerebellar Loop
- ClinicalTrials.gov ID
- NCT06912191
- Acronym / sponsor ID
- Shen-PJ-Ke-2024-138
- Conditions
- Post-stroke Depression
- Keywords
- EEG, ERP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Second Affiliated Hospital of Kunming Medical UniversityUniversity, hospital or other
- Study start
- 30 Mar 2025 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 4 Apr 2025 (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.
Experiment1: Using a brain EEG-TMS combined system, researchers aim to investigate the impact of the rostral anterior cingulate cortexr (rACC)-engaging cognitive task (RECT) combined single-pulse TMS magnetic stimulation on theta neural oscillations in the medial frontal lobe. The study will be divided into 4 groups: the first group will receive left cerebellar single-pulse TMS stimulation combined with the RECT task, the second group will receive right cerebellar single-pulse TMS stimulation combined with the RECT task, the third group will receive midline cerebellar single-pulse TMS stimulation combined with the RECT task, and the fourth group will receive sham cerebellar single-pulse TMS stimulation combined with the RECT task. Divide the participants into groups of 15 people each, following a 1:1:1:1 ratio. Based on the above testing, the stimulus method that results in the most significant change in the midline of the frontal lobe will be identified.
Experiment 2: Based on the research from Experiment 1, the most significant approach affecting theta neural oscillations in the medial frontal gyrus will be identified. This stimulation protocol will be combined with left dorsolateral prefrontal cortex iTBS stimulation in Experiment 2. The research aim of Experiment 2 is to investigate the most effective stimulation method for enhancing midline theta neural oscillations in the frontal lobe, in combination with left dorsolateral prefrontal cortex iTBS, for the treatment of post-stroke depression patients. This study will include 40 post-stroke depressed patients, and each participant must meet the inclusion criteria. The first group of participants, consisting of 20 individuals, will receive the optimal combination intervention. The second group of participants will only receive iTBS stimulation, without any additional intervention strategies used in Experiment 1. Patients will undergo Hamilton Depression Scale assessment and resting state and task state EEG collection at baseline, one week after intervention, and two weeks after intervention.The primary outcome will be the Hamilton Depression Scale, with EEG-related data being analyzed as a secondary outcome. Task-oriented EEG detection will include both facial expression recognition paradigm and oddball experiment paradigm. Reaction time, accuracy, and completion status will be recorded simultaneously in the experiment. The experiment will record patients' tolerance and any adverse events that occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| LC TMS combined with the RECT task (Experiment1) | Experimental | Other: Left cerebellar TMS stimulation combined with the RECT taskLeft cerebellar single-pulse TMS stimulation combined with the RECT task |
| RC TMS combined with the RECT task (Experiment1) | Experimental | Other: Right cerebellar TMS stimulation combined with the RECT taskRight cerebellar single-pulse TMS stimulation combined with the RECT task |
| MC TMS combined with the RECT task (Experiment1) | Experimental | Other: Midline cerebellar TMS stimulation combined with the RECT taskMidline cerebellar single-pulse TMS stimulation combined with the RECT task |
| Sham cerebellar single-pulse TMS stimulation combined with the RECT task (Experiment1) | Sham comparator | Other: Sham cerebellar TMS stimulation combined with the RECT taskSham cerebellar single-pulse TMS stimulation combined with the RECT task, The TMS coil was placed at the cerebellar site but tilted 90° to prevent effective magnetic field penetration. |
| Combined Stimulus Intervention group （Experiment 2） | Experimental | Other: The best stimulation protocol combined with left dorsolateral prefrontal cortex iTBSCombined iTBS stimulation of the dorsolateral prefrontal cortex and TMS of the cerebellum with the RECT task intervention group |
| iTBS treatment group（Experiment 2） | Experimental | Other: Left dorsolateral prefrontal cortex iTBS stimulation, as well as sham TMS stimulation and sham RECT task.The group of participants will receive left dorsolateral prefrontal cortex iTBS stimulation, as well as sham cerebellar TMS stimulation and sham RECT task. |
| Traditional treatment group（Experiment 2） | Sham comparator | Other: Sham left dorsolateral prefrontal cortex iTBS stimulation, sham cerebellar TMS stimulation, and sham RECT task.The group of participants will receive sham left dorsolateral prefrontal cortex iTBS stimulation, sham cerebellar TMS stimulation, and sham RECT task. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Onset of stroke <6 months ago, or >6 months since the last stroke event;
- Age >=18 years and <85 years (as the probability of Vascular Cognitive Impairment increases above 85);
- Patients with damage in the middle cerebral artery territory;
- NIHSS >4 and <26;
- mRS score >=2;
Key exclusion criteria (13 listed)
- History of epilepsy or psychiatric disorders (including depression, anxiety, or schizophrenia);
- Severe comorbidities;
- History of medication use: benzodiazepines, baclofen, antidepressants;
- Non-compliance with the treatment plan;
- Acute-phase cerebral hemorrhage, acute infectious diseases;
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 |
|---|---|---|
| Left cerebellar TMS stimulation combined with the RECT taskAlso: RECT task, TMSThe first group will receive left cerebellar single-pulse TMS stimulation combined with the RECT task. RECT refers to rostral anterior cingulate cortexr (rACC)-engaging cognitive task. The theoretical basis of this task is that when subjects are in a state of focused attention, the power of theta neural oscillations in the midline of their frontal lobe will increase. By considering the features of post-stroke depression, this study combines the emotional recognition task with the RECT task. During each trial, individuals will view 4 faces consecutively, each displaying a different expression, and they will be required to memorize the sequence of expressions. Emoticons consist of joy, sorrow, and rage. After displaying four facial expressions, a brief text flowchart will appear. Participants need to check if the sequence reflected in the flowchart matches the order in which the four facial expressions appeared. If they match, click the left mouse button; if they do not match, click the | Other | LC TMS combined with the RECT task (Experiment1) |
| Right cerebellar TMS stimulation combined with the RECT taskAlso: RECT task, TMSRight cerebellar single-pulse TMS stimulation combined with the RECT task | Other | RC TMS combined with the RECT task (Experiment1) |
| Midline cerebellar TMS stimulation combined with the RECT taskAlso: RECT task, TMSMidline cerebellar single-pulse TMS stimulation combined with the RECT task | Other | MC TMS combined with the RECT task (Experiment1) |
| Sham cerebellar TMS stimulation combined with the RECT taskAlso: RECT taskSham cerebellar single-pulse TMS stimulation combined with the RECT task, The TMS coil was placed at the cerebellar site but tilted 90° to prevent effective magnetic field penetration. | Other | Sham cerebellar single-pulse TMS stimulation combined with the RECT task (Experiment1) |
| The best stimulation protocol combined with left dorsolateral prefrontal cortex iTBSAlso: left dorsolateral prefrontal cortex iTBS, RECT task, TMSThe optimal stimulation protocol determined in Experiment 1 combined with stimulation of the left dorsolateral prefrontal cortex. | Other | Combined Stimulus Intervention group （Experiment 2） |
| Left dorsolateral prefrontal cortex iTBS stimulation, as well as sham TMS stimulation and sham RECT task.Also: left dorsolateral prefrontal cortex iTBSSubjects in the group underwent left dorsolateral prefrontal cortex iTBS stimulation, in addition to receiving sham TMS stimulation and participating in a sham RECT task. The sham RECT task involves having participants watch a continuous scroll of faces without needing to react. | Other | iTBS treatment group（Experiment 2） |
| Sham left dorsolateral prefrontal cortex iTBS stimulation, sham cerebellar TMS stimulation, and sham RECT task.The participants in this group received sham left dorsolateral prefrontal cortex iTBS stimulation, sham cerebellar TMS stimulation, and sham RECT task. | Other | Traditional treatment group（Experiment 2） |
Primary outcome
Montgomery-Asberg Depression Rating Scale，MADRS
Time frame: Day1
This scale will be the primary outcome measure for Experiment 2. Montgomery-Asberg Depression Rating Scale，MADRS: Extreme depression: MADRS >35; Major depression: MADRS >30; Moderate depression: MADRS >22; Mild depression: MADRS >12; Remission stage: MADRS <12.
Electroencephalogram
Time frame: Day 1
EEG will be the main outcome measures for Experiment 1 and Experiment 2. EEG power in the delta, theta, alpha, beta band: the power spectral density (PSD) in unit^2/Hz Functional connectivity---Phase locking value (PLV): The value of PLV ranges from 0 to 1 Event related potentials in amplitude/μV
7 secondary outcomes
Mini-mental state examination,MMSE
Time frame: Day 1
Montreal Cognitive Assessment, MoCA
Time frame: Day 1
Hamilton Depression Scale，HAMD
Time frame: Day 1
Hamilton Anxiety Scale，HAMA
Time frame: Day 1
Quick Inventory of Depressive Symptomatology Self-Report, QIDS-SR16
Time frame: Day 1
Response time
Time frame: Day 1
Accuracy rates
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Left cerebellar TMS stimulation combined with the RECT task, Right cerebellar TMS stimulation combined with the RECT task and Midline cerebellar TMS stimulation combined with the RECT task in people with Post-stroke Depression, run by The Second Affiliated Hospital of Kunming Medical University.
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 8 inclusion and 13 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: opening soon, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zihan Chen (+8618208812691, 18208812691@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale，MADRS (time frame: Day1). 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?
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 4 Apr 2025.