Major Depressive EpisodePhase 3MOODBOOSTERNCT06508710
Early Effects of Ketamine vs Placebo With Venlafaxine in Severe Depression Patients
A Phase 3 study testing Ketamine in people with Major Depressive Episode, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
Trial summary
Unipolar major depressive disorder is the leading cause of disability worldwide. The most commonly used treatments for major depressive episodes (MDE) are antidepressant medications. However, they have limited efficacy and their onset of action is long, ranging between 2 to 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Episode
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesFrance
- Study dates
- 20 Oct 2024to Apr 2026
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current MDE in the context of unipolar major depressive disorder (DSM-5 criteria), hospitalized (open care) for this episode, with a minimum HDRS score of 24 and in the context of an indication for the introduction of venlafaxine treatment.
- Patient aged between 18 and 65.
- Signed free and informed consent
- Membership of a social security scheme
- For women of childbearing age, effective contraception throughout study participation.* (*Combined hormonal contraception (containing estrogen and progestin) associated with ovulation inhibition: (oral, intravaginal, transdermal), Progestin-only hormonal contraception associated with ovulation inhibition: (oral, injectable, implantable), Intrauterine device (IUD), Hormonal intrauterine system (IUS), Bilateral tubal occlusion, Vasectomized partner, Sexual abstinence.)
Who cannot join
- Criteria relating to associated pathologies entailing particular risks: pharmaco-resistant CDE (failure of at least two properly conducted treatments with two different antidepressant treatment classes), CDE with psychotic features, psychotic disorder, bipolar disorder, current (<1 month) substance use disorder (excluding tobacco).
- Liver impairment (AST and/or ALT > 3 ULN, PAL and/or GGT and/or bilirubin > 2 ULN).
- Severe renal insufficiency (GFR <30ml/min with Cockcroft's formula).
- Bradycardia less than 55 beats per minute.
- Contraindication to ketamine : Hypersensitivity to active substance or excipients, comatose state, central nervous system (CNS) depression, Parkinson's disease, Lewy body dementia, progressive supranuclear palsy, known prolongation of the QTc interval (>450ms for men and >470ms for women) or congenital long QT syndrome, recent acute myocardial infarction, uncompensated heart failure, history of ventricular arrhythmias or torsades de pointes, uncorrected hypokalemia (K+ < 3. 5 mmol/l), epilepsy, uncontrolled hypertension, porphyria, history of stroke (CVA), intracranial hypertension.
- Contraindication to venlafaxine (hypersensitivity to venlafaxine or excipients, are hereditary conditions of fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency, unstable hypertension, no indication for venlafaxine treatment in clinician's opinion due to ineffectiveness or tolerability of previous venlafaxine treatment).
Show all 17Show fewer
- Current or previous treatment with venlafaxine or ketamine in the month prior to study inclusion.
- Need to maintain another antidepressant, MAOI, Millepertuis or benzodiazepines (cyamemazine is permitted). Or potential drug interactions in case of recent cessation of these treatments (based on the Summary of Product Characteristics (SmPC) of the respective medication(s) and their half-life).
- Any other unspecified reason (clinically significant illness or anomaly) which, in the opinion of the investigator or the sponsor, could compromise the safety of the participant.
- Pregnant or breast-feeding patients (women of childbearing potential must have a negative urine or blood test for human chorionic gonadotropin prior to trial entry). Planned pregnancy within three months of enrolment
- Adult under guardianship, curatorship or safeguard of justice
- Participating in other interventional research involving the human body or within the exclusion period following previous research involving the human body, if applicable.
- Social insurance
- Additional criteria for inclusion in the ancillary study :
- Contraindications to [11C]UCB-J PET-MRI
- Absolute contraindications: Pacemaker or neurosensorial stimulator or implantable defibrillator; clip on a brain aneurysm or vascular malformation; intraocular or intracerebral ferromagnetic foreign body; prostheses or objects or mobile ferromagnetic metal fragments; cochlear implants; peripheral stimulator; neurosurgical ventriculoperitoneal shunt valves; automated injection device such as insulin pump, glucose sensor; permanent eyelid or lip makeup; non-removable piercing; claustrophobia.
- Relative contraindications: Dental prostheses and orthodontic material; certain intrauterine devices; certain tattoos; certain transdermal patch implants; certain metal implants far from the examined area. (The investigator physician and/or radiology operator will always conduct a precise questionnaire before the examination to ensure perfect safety and absence of MRI danger)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 3 recruiting
- Not yet recruiting
EPS Barthélémy Durand
Étampes, 91152
christian trichard, 01.69.46.86.66, Christian.Trichard@eps-etampes.fr
christian trichard
- Recruiting
Psychiatry unit
Le Kremlin-Bicêtre, France, 94270
Romain COLLE, MD - PHD, +33145212524, romain.colle@aphp.fr
Romain Colle, MD-PHD
- Not yet recruiting
Bicetre Hospital - CRC
Le Kremlin-Bicêtre, 94250
laurent becquemont, 01.45.21.74.51, laurent.becquemont@aphp.fr
laurent becquemont
- Active, not recruiting
CEA/SHFJ
Orsay, 94401
About this study
Official title: Early Efficacy of Ketamine Compared With Placebo as Adjunctive Therapy With Venlafaxine in Severely Unipolar Depressed Inpatients
Unipolar major depressive disorder is the leading cause of disability worldwide. The most commonly used treatments for major depressive episodes (MDE) are antidepressant medications. However, they have limited efficacy and their onset of action is long, ranging between 2 to 6 weeks. During this period, hospitalization can become necessary, especially for severe MDE. It is crucial to improve the early effectiveness of treatments for these patients in order to alleviate their suffering, limit complications (suicidal risk), and reduce hospitalization durations (approximately 1000 euros per day). The efficacy of intravenous ketamine has been demonstrated in pharmaco-resistant depression but remains to be proven in non-pharmaco-resistant severe MDE. Additionally, PET imaging using [11C]UCB-J, which allows the in vivo study of synaptic density in the human brain, has shown significant decreases in synaptic density in unipolar patients with severe MDE. Furthermore, a single ketamine infusion was found to enhance synaptogenesis
- Conditions
- Major Depressive Episode
- Being tested
- Ketamine, Placebo
- Keywords
- depression, ketamine, synaptogenesis
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Ketamine+Venlafaxine
Patients randomized in this group will receive an intravenous ketamine in addition to venlafaxine for one week (on Days 1, 4 and 7)
PlaceboDrug
Also called Placebo+Venlafaxine
Patients randomized in this group will receive an intravenous placebo in addition to venlafaxine for one week (on Days 1, 4 and 7)
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Group | Experimental | The patient will receive 3 doses of intravenous ketamine (0,50mg/kg) in addition to the usual venlafaxine treatment Receives: Drug: Ketamine |
| Placebo group | Placebo comparator | The patient will receive 3 doses of intravenous placebo (50mL of NaCl 9‰) in addition to the usual venlafaxine treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the early efficacy on depressive symptomatology
Evolution of the total score of the Hamilton Depression Rating Scale (HDRS 17 items: scale items are rated from 0 to 2 or from 0 to 4 and the score ranges from 0 to 52) after 7 days of treatment by venlafaxine The HDRS scale will be assessed by a senior psychiatrist or psychologist trained in administering the scales, following a psychiatric interview
Measured: at day 0 and day 7
Secondary outcomes (20)
The efficacy of ketamine on HDRS overall score
To compare the efficacy of ketamine as adjunctive therapy, after the early adjunctive treatment phase, and placebo, by assessing changes in overall score obtained on the HDRS 17-items.
Measured: at day 1,4,7,14, 28 and 42 following the initiation of treatment by venlafaxine
The efficacy of Ketamine on HDRS response rate
To compare the efficacy of ketamine as adjunctive therapy, after the early adjunctive treatment phase, and placebo, by assessing HDRS response rate (improvement of 50% or more in the overall HDRS score) between groups
Measured: at day 1,4,7,14, 28 and 42 following the initiation of treatment by venlafaxine
The efficacy of Ketamine on HDRS remission rate
at day 1,4,7,14, 28 and 42 following the initiation of treatment by venlafaxine
Measured: To compare the efficacy of ketamine as adjunctive therapy, after the early adjunctive treatment phase, and placebo, by assessing remission rate (HDRS 17 items ≤ 7) between groups
The efficacy of ketamine on BDI overall score
To compare the efficacy of ketamine as adjunctive therapy, after the early adjunctive treatment phase, and placebo, by assessing changes in overall score obtained on the short form of the Beck Depression Inventory (BDI)
Measured: at day 1,4,7,14, 28 and 42 following the initiation of treatment by venlafaxine
The efficacy of ketamine on CGI scale
To compare the efficacy of ketamine as adjunctive therapy, after the early adjunctive treatment phase, and placebo, by assessing changes in Clinical Global Impression (CGI) scale
Measured: at day 1,4,7,14, 28 and 42 following the initiation of treatment by venlafaxine
Duration of hospitalization
Evaluate whether ketamine as adjunctive therapy reduces the length of hospital stay, noting the number of days spent in hospital (including re-hospitalization) The discharge from hospitalization will be decided by the treatment-blinded clinician responsible for the patient
Measured: 42 days
Reduction of suicidal ideation
Evaluate whether adjunctive ketamine reduces early suicidal ideation, by assessement of overall Columbia-Suicide Severity Rating Scale (C-SSRS) score, after 7 days of treatment by venlafaxine
Measured: at day 0 and day 7
Clinical improvement on HDRS overall score
Evaluate whether ultra-early improvement (at D1 or D4 of treatment by venlafaxine) predicts clinical improvement at D7, D14, D28 and D42 by tracking changes in overall score obtained on the 17-item Hamilton Depression Rating Scale (HDRS)
Measured: at day 7, 14, 28 and 42
Clinical improvement on HDRS response rate
Evaluate whether ultra-early improvement (at D1 or D4 of treatment by venlafaxine) predicts clinical improvement at D7, D14, D28 and D42 by tracking HDRS response rate (improvement of 50% or more in the overall HDRS score)
Measured: at day 7, 14, 28 and 42
Clinical improvement on HDRS remission rate
Evaluate whether ultra-early improvement (at D1 or D4 of treatment by venlafaxine) predicts clinical improvement at D7, D14, D28 and D42 by tracking remission rate (HDRS 17 items ≤ 7)
Measured: at day 7, 14, 28 and 42
Clinical improvement on BDI overall score
Evaluate whether ultra-early improvement (at D1 or D4 of treatment by venlafaxine) predicts clinical improvement at D7, D14, D28 and D42 by tracking changes in overall score obtained on the short form of the Beck Depression Inventory (BDI)
Measured: at day 7, 14, 28 and 42
Clinical improvement on CGI scale
Evaluate whether ultra-early improvement (at D1 or D4 of treatment by venlafaxine) predicts clinical improvement at D7, D14, D28 and D42 by tracking changes in Clinical Global Impression (CGI) scale
Measured: at day 7, 14, 28 and 42
Tolerance on blood pressure
Tolerance will be assessed according to CTCAE grade (version 5.0), with special monitoring of the effects of ketamine during and up to 40 minutes post-infusion of treatment or placebo on blood pressure
Measured: Day 1, 4, 7
Tolerance on heart rate
Tolerance will be assessed according to CTCAE grade (version 5.0), with special monitoring of the effects of ketamine during and up to 40 minutes after infusion of treatment or placebo on heart rate.
Measured: Day 1, 4, 7
Tolerance on respiratory rate
Tolerance will be assessed according to CTCAE grade (version 5.0), with special monitoring of the effects of ketamine during and up to 40 minutes after infusion of treatment or placebo on respiratory rate
Measured: Day 1, 4, 7
Tolerance on nausea and vomiting
Tolerance will be assessed according to CTCAE grade (version 5.0), with special monitoring of the effects of ketamine during and up to 40 minutes after infusion of treatment or placebo on nausea/vomiting
Measured: Day 1, 4, 7
Tolerance on dissociation
Tolerance will be assessed according to CTCAE grade (version 5.0), with special monitoring of the effects of ketamine during and up to 40 minutes after infusion of treatment or placebo on dissociation
Measured: Day 1, 4, 7
Tolerance on headaches
Tolerance will be assessed according to CTCAE grade (version 5.0), with special monitoring of the effects of ketamine during and up to 40 minutes after infusion of treatment or placebo on headaches
Measured: Day 1, 4, 7
The consumption of anxiolytic treatments
cumulative consumption in mg of cyamemazine will be recorded over the entire study period
Measured: During all the study
Biomarkers
Identify biomarkers predictive or associated with the efficacy of venlafaxine associated with ketamine
Measured: Day 1 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start20 Oct 2024
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive EpisodeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain COLLE, Principal investigator, Service Hospitalo-Universitaire de Psychiatrie - Hôpital Bicêtre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508710
- Sponsor's protocol ID
- APHP220668
- Other IDs
- 2023-506597-12-00, 2023
- Acronym
- MOODBOOSTER
- Status last verified
- Dec 2024
- First submitted
- 15 Jul 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Efficacy of Ketamine Compared With Placebo as Adjunctive Therapy With Venlafaxine in Severely Unipolar Depressed Inpatients
- ClinicalTrials.gov ID
- NCT06508710
- Acronym / sponsor ID
- MOODBOOSTER / APHP220668
- Conditions
- Major Depressive Episode
- Keywords
- depression, ketamine, synaptogenesis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 18 Jul 2024 (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.
Unipolar major depressive disorder is the leading cause of disability worldwide. The most commonly used treatments for major depressive episodes (MDE) are antidepressant medications. However, they have limited efficacy and their onset of action is long, ranging between 2 to 6 weeks. During this period, hospitalization can become necessary, especially for severe MDE. It is crucial to improve the early effectiveness of treatments for these patients in order to alleviate their suffering, limit complications (suicidal risk), and reduce hospitalization durations (approximately 1000 euros per day). The efficacy of intravenous ketamine has been demonstrated in pharmaco-resistant depression but remains to be proven in non-pharmaco-resistant severe MDE. Additionally, PET imaging using [11C]UCB-J, which allows the in vivo study of synaptic density in the human brain, has shown significant decreases in synaptic density in unipolar patients with severe MDE. Furthermore, a single ketamine infusion was found to enhance synaptogenesis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Group | Experimental | Drug: KetamineThe patient will receive 3 doses of intravenous ketamine (0,50mg/kg) in addition to the usual venlafaxine treatment |
| Placebo group | Placebo comparator | Drug: PlaceboThe patient will receive 3 doses of intravenous placebo (50mL of NaCl 9‰) in addition to the usual venlafaxine treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Current MDE in the context of unipolar major depressive disorder (DSM-5 criteria), hospitalized (open care) for this episode, with a minimum HDRS score of 24 and in the context of an indication for the introduction of venlafaxine treatment.
- Patient aged between 18 and 65.
- Signed free and informed consent
- Membership of a social security scheme
- For women of childbearing age, effective contraception throughout study participation.* (*Combined hormonal contraception (containing estrogen and progestin) associated with ovulation inhibition: (oral, intravaginal, transdermal), Progestin-only hormonal contraception associated with ovulation inhibition: (oral, injectable, implantable), Intrauterine device (IUD), Hormonal intrauterine system (IUS), Bilateral tubal occlusion, Vasectomized partner, Sexual abstinence.)
Key exclusion criteria (17 listed)
- Criteria relating to associated pathologies entailing particular risks: pharmaco-resistant CDE (failure of at least two properly conducted treatments with two different antidepressant treatment classes), CDE with psychotic features, psychotic disorder, bipolar disorder, current (<1 month) substance use disorder (excluding tobacco).
- Liver impairment (AST and/or ALT > 3 ULN, PAL and/or GGT and/or bilirubin > 2 ULN).
- Severe renal insufficiency (GFR <30ml/min with Cockcroft's formula).
- Bradycardia less than 55 beats per minute.
- Contraindication to ketamine : Hypersensitivity to active substance or excipients, comatose state, central nervous system (CNS) depression, Parkinson's disease, Lewy body dementia, progressive supranuclear palsy, known prolongation of the QTc interval (>450ms for men and >470ms for women) or congenital long QT syndrome, recent acute myocardial infarction, uncompensated heart failure, history of ventricular arrhythmias or torsades de pointes, uncorrected hypokalemia (K+ < 3. 5 mmol/l), epilepsy, uncontrolled hypertension, porphyria, history of stroke (CVA), intracranial hypertension.
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 |
|---|---|---|
| KetamineAlso: Ketamine+VenlafaxinePatients randomized in this group will receive an intravenous ketamine in addition to venlafaxine for one week (on Days 1, 4 and 7) | Drug | Ketamine Group |
| PlaceboAlso: Placebo+VenlafaxinePatients randomized in this group will receive an intravenous placebo in addition to venlafaxine for one week (on Days 1, 4 and 7) | Drug | Placebo group |
Primary outcome
the early efficacy on depressive symptomatology
Time frame: at day 0 and day 7
Evolution of the total score of the Hamilton Depression Rating Scale (HDRS 17 items: scale items are rated from 0 to 2 or from 0 to 4 and the score ranges from 0 to 52) after 7 days of treatment by venlafaxine The HDRS scale will be assessed by a senior psychiatrist or psychologist trained in administering the scales, following a psychiatric interview
20 secondary outcomes
The efficacy of ketamine on HDRS overall score
Time frame: at day 1,4,7,14, 28 and 42 following the initiation of treatment by venlafaxine
The efficacy of Ketamine on HDRS response rate
Time frame: at day 1,4,7,14, 28 and 42 following the initiation of treatment by venlafaxine
The efficacy of Ketamine on HDRS remission rate
Time frame: To compare the efficacy of ketamine as adjunctive therapy, after the early adjunctive treatment phase, and placebo, by assessing remission rate (HDRS 17 items ≤ 7) between groups
The efficacy of ketamine on BDI overall score
Time frame: at day 1,4,7,14, 28 and 42 following the initiation of treatment by venlafaxine
The efficacy of ketamine on CGI scale
Time frame: at day 1,4,7,14, 28 and 42 following the initiation of treatment by venlafaxine
Duration of hospitalization
Time frame: 42 days
Reduction of suicidal ideation
Time frame: at day 0 and day 7
Clinical improvement on HDRS overall score
Time frame: at day 7, 14, 28 and 42
Clinical improvement on HDRS response rate
Time frame: at day 7, 14, 28 and 42
Clinical improvement on HDRS remission rate
Time frame: at day 7, 14, 28 and 42
Clinical improvement on BDI overall score
Time frame: at day 7, 14, 28 and 42
Clinical improvement on CGI scale
Time frame: at day 7, 14, 28 and 42
Tolerance on blood pressure
Time frame: Day 1, 4, 7
Tolerance on heart rate
Time frame: Day 1, 4, 7
Tolerance on respiratory rate
Time frame: Day 1, 4, 7
Tolerance on nausea and vomiting
Time frame: Day 1, 4, 7
Tolerance on dissociation
Time frame: Day 1, 4, 7
Tolerance on headaches
Time frame: Day 1, 4, 7
The consumption of anxiolytic treatments
Time frame: During all the study
Biomarkers
Time frame: Day 1 and 14
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 3 Sep 2025.
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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.
Romain COLLE principal investigator
Service Hospitalo-Universitaire de Psychiatrie - Hôpital Bicêtre
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ketamine in people with Major Depressive Episode, run by Assistance Publique - Hôpitaux de Paris at 4 sites in France.
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 5 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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. 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.
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?
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 Romain COLLE (+33145212524, romain.colle@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the early efficacy on depressive symptomatology (time frame: at day 0 and day 7). 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 3 Sep 2025.