Major Depressive Disorder (MDD)Phase 4NCT06675851
Reward-specific Changes of the Chemical Messenger Dopamine in the Brain of Healthy and Depressed People
A Phase 4 study testing WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline and Cipralex (escitalopram) in people with Major Depressive Disorder (MDD), run by Medical University of Vienna at 1 site in Austria.
Trial summary
Major depressive disorder was shown to be associated with pathological alterations within neurotransmitter systems of the brain. Based on earlier study results, it is assumed that the neurotransmitter dopamine is relevant for several symptoms of depression, e.g., loss of interest or pleasure and lack of motivation. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline and Cipralex (escitalopram)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2022to Dec 2026
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects aged between 18-65 years of age
- Depressive patients: DSM-IV diagnosis of MDD following SCID I, HDRS29, MADRS and BDI-II
- Satisfactory general health as determined by past medical history, physical examination, vital signs at screening
- Vital signs measured after 3 minutes resting in the supine position must be within the following ranges: oral body temperature between 35.0-37.5 °C, systolic blood pressure 90-140 mmHg, diastolic blood pressure 50-90 mm Hg, pulse rate 40-100 bpm
- Subjects must weigh 50-100 kg to participate in this study with a BMI within 19-26.
- Sufficient visual and auditory performance for neuropsychological testing
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- Written informed consent will be obtained prior to the start of any study procedures. Therefore, willingness and competence to sign the informed consent form is needed.
- Potential patients must be able to communicate well with the investigator and comply with the requirements of the study
- Only participants who are legally authorized to give informed consent will be included in the present study.
Who cannot join
- Depressed patients: Presence of any severe / unstable neurological, somatic or psychiatric comorbidity
- Healthy controls: Any psychiatric disease or any severe / unstable neurological or somatic disease
- Presence of psychotic symptoms
- Acute suicidality
- Any contraindication for magnetic resonance or PET imaging
- Presence of any metallic implant in the head
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- History of clinically significant drug allergy; history of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to one of the study drugs or multiple study drugs (known hypersensitivity to bupropion, escitalopram)
- Other clinically significant abnormality on physical, neurological, or laboratory examination or on electrocardiogram (ECG) that, in the opinion of the investigator precludes the patient from the study
- Ingestion of antidepressants or other psychotropic agents within the last 6 months Previous escitalopram- or bupropion intake
- Antidepressive trials wit DBS, electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or Ketamine
- Current smoking, substance abuse including alcohol, drugs of abuse, or any medication in a manner which is indicative of substance-related disorders (e.g. substance dependency) according to DSM-IV
- Failure to comply with the study protocol or follow the instructions of the investigators
- Positive urine pregnancy test
- Known pregnancy or lactation
- MRI scan that shows evidence of stroke, infarct, or other space occupying lesion or structural abnormality
- History of any other drug or alcohol abuse or misuse
- Participation in any clinical investigation within 12 weeks prior to dosing
- Evidence from an Allen test of incomplete communication between the radial and ulnar artery, in either hand
- Significant radiation exposure (>5 mSv) in the frame of participation in trials within the past 10 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rupert Lanzenberger, Univ.-Prof. Priv.-Doz. Dr. contact
Patricia Anna Handschuh, Dr.med.univ., BA contact
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Rupert Lanzenberger, Univ.-Prof. Priv.-Doz. Dr., +43 1 40400 35760, rupert.lanzenberger@meduniwien.ac.at
Godber Mathis Godbersen, Dr.med.univ, PhD
About this study
Official title: Reward-specific Changes of Cerebral Dopamine Synthesis in Healthy Volunteers and Depressed Patients
Major depressive disorder was shown to be associated with pathological alterations within neurotransmitter systems of the brain. Based on earlier study results, it is assumed that the neurotransmitter dopamine is relevant for several symptoms of depression, e.g., loss of interest or pleasure and lack of motivation. Thus, it is assumed that the synthesis of dopamine in the brain of depressed individuals could be impaired. The specific effect of common antidepressants on the human reward system in depression has not yet been sufficiently investigated. In particular, it is unclear whether depressed patients exhibit reward-specific changes of dopamine synthesis, and whether or not these changes can be differentially affected by diverse types of antidepressants. Neurotransmitter systems can be visualized in the brain using positron emission tomography (PET). Additionally, brain structure and function can be studied using magnetic resonance imaging (MRI). For the visualization of dopamine synthesis in the brain, the radioligand [18F]FDOPA can be used in PET measurements. To assess task-relevant changes of diverse radioligands and thus specific metabolic processes in the brain during specific tasks, a recently developed PET-approach can be used which has already been successfully applied in a pilot study with healthy volunteers. In the present project, 60 depressed subjects and 30 healthy controls will undergo PET/MR-imaging twice. Depressed subjects will be assigned to 1 of 2 treatment groups. 30 depressive subjects will receive bupropion, the other 30 patients will be treated with escitalopram. After a treatment period of 6 weeks, the 2nd PET measurement will be performed in all participants, aiming to detect potential reward-specific changes of dopamine synthesis. The investigators hypothesize that reward-specific changes of dopamine synthesis will be lower in depressed subjects than in healthy controls, that reward-specific changes of dopamine synthesis will be significantly higher in the bupropion group than in the escitalopram group, and that the changes of dopamine synthesis will be associated with functional changes in the brain (measured by simultaneous functional MRI scans). This will be the first study comparing the effects of escitalopram and bupropion on task-specific dopamine synthesis and thus on the human reward system. The study is expected to yield new insights for individual treatment concepts in the therapy of depression.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline, Cipralex (escitalopram)
- Keywords
- functional PET, PET/MRI, Reward, Bupropion, Escitalopram, MDD, Depression, nucleus accumbens, dopamine synthesis, FDOPA
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKlineDrug
Bupropion 150 mg daily after baseline PET/MRI or MRI/MRS over 6-8 weeks
Cipralex (escitalopram)Drug
Escitalopram 10 mg daily after baseline PET/MRI or MRI/MRS over 6-8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Antidepressant treatment in MDD patients with bupropion | Active comparator | Bupropion 150 mg daily after baseline PET/MRI or MRI/MRS over 6-8 weeks Receives: Drug: WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline |
| Antidepressant treatment in MDD patients with escitalopram | Active comparator | Escitalopram 10 mg daily after baseline PET/MRI or MRI/MRS over 6-8 weeks Receives: Drug: Cipralex (escitalopram) |
| Healthy Controls without antidepressant intake | No intervention | Healthy controls will only attend imaging procedures without medication intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of the reward specific dopamine synthesis rate in the nucleus accumbens of depressed individuals after 6-8 weeks of antidepressant intake assessed via functional PET
Reward-specific dopamine synthesis rate: Assessment of the net influx constant Ki in the nucleus accumbens via functional PET using [18F]FDOPA as an index of the dopamine synthesis rate
Measured: 6-8 weeks
Relationship between potential changes of the reward-specific dopamine synthesis rate in the nucleus accumbens assessed via functional PET and treatment response in depressed individuals after 6-8 weeks of antidepressant intake
Reward-specific dopamine synthesis rate: Assessment of the net influx constant Ki in the nucleus accumbens via functional PET using [18F]FDOPA as an index of the dopamine synthesis rate; Treatment response rates will be assessed at baseline and after 6-8 weeks of antidepressant therapy via the Hamilton Depression Rating Scale with 29 items (HDRS29) and the Montgomery-Åsberg Depression Rating Scale (MADRS).
Measured: 6-8 weeks
Difference in changes to the reward-specific dopamine synthesis rate in the nucleus accumbens assessed via functional PET in depressed patients taking bupropion vs. escitalopram after 6-8 weeks of therapy
Reward-specific dopamine synthesis rate: Assessment of the net influx constant Ki in the nucleus accumbens via functional PET using [18F]FDOPA as an index of the dopamine synthesis rate
Measured: 6-8 weeks
Secondary outcomes (3)
Relationship between the reward-specific dopamine synthesis rate (assessed via functional PET) and fMRI activation across healthy volunteers and depressed patients, both at baseline and after 6-8 weeks of therapy
Reward-specific dopamine synthesis rate: Assessment of the net influx constant Ki in the nucleus accumbens via functional PET using [18F]FDOPA as an index of the dopamine synthesis rate; fMRI activation: Blood-Oxygenation-Level Dependent Signal via functional Magnetic Resonance Imaging
Measured: 6-8 weeks
Remission rates in depressed patients being treated with either escitalopram or bupropion in a longitudinal design
Remission rates will be assessed at baseline and after 6-8 weeks of antidepressant therapy via the Hamilton Depression Rating Scale with 29 items (HDRS29) and the Montgomery-Åsberg Depression Rating Scale (MADRS).
Measured: 6-8 weeks
Test-retest reliability for the quantification of dopamine synthesis rates in healthy volunteers via functional PET
Reward-specific dopamine synthesis rate: Assessment of the net influx constant Ki in the nucleus accumbens via functional PET using [18F]FDOPA as an index of the dopamine synthesis rate; assessed at baseline and after 6-8 weeks without any interventions in between
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Dec 2022
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, prospective, longitudinal (optional cross-over-design in selected patients)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Austrian Science Fund (FWF)
- Responsible party
- Principal investigator, Rupert Lanzenberger, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675851
- Sponsor's protocol ID
- 2321/2019
- Other IDs
- 2019-004880-33, 2019
- Status last verified
- Nov 2024
- First submitted
- 31 Oct 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reed MB, Handschuh PA, Schmidt C, Murgas M, Gomola D, Milz C, Klug S, Eggerstorfer B, Aichinger L, Godbersen GM, Nics L, Traub-Weidinger T, Hacker M, Lanzenberger R, Hahn A. Validation of cardiac image-derived input functions for functional PET quantification. Eur J Nucl Med Mol Imaging. 2024 Jul;51(9):2625-2637. doi: 10.1007/s00259-024-06716-8. Epub 2024 Apr 27.
PubMed 38676734Schlosser G, Handschuh PA, Murgas M, Graf S, Milz C, Klug S, Falb P, Schmidt C, Eggerstorfer B, Briem E, Mayerweg A, Artmeier L, Godbersen GM, Nics L, Rasul S, Hacker M, Hahn A, Lanzenberger R, Reed MB. Test-retest reliability of dopaminergic fPET and fMRI measures during reward processing. Neuroimage. 2026 Sep;338:122047. doi: 10.1016/j.neuroimage.2026.122047. Epub 2026 Jun 9.
PubMed 42264114
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reward-specific Changes of Cerebral Dopamine Synthesis in Healthy Volunteers and Depressed Patients
- ClinicalTrials.gov ID
- NCT06675851
- Acronym / sponsor ID
- 2321/2019
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- functional PET, PET/MRI, Reward, Bupropion, Escitalopram, MDD, Depression, nucleus accumbens
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Austrian Science Fund (FWF)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Nov 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.
Major depressive disorder was shown to be associated with pathological alterations within neurotransmitter systems of the brain. Based on earlier study results, it is assumed that the neurotransmitter dopamine is relevant for several symptoms of depression, e.g., loss of interest or pleasure and lack of motivation. Thus, it is assumed that the synthesis of dopamine in the brain of depressed individuals could be impaired. The specific effect of common antidepressants on the human reward system in depression has not yet been sufficiently investigated. In particular, it is unclear whether depressed patients exhibit reward-specific changes of dopamine synthesis, and whether or not these changes can be differentially affected by diverse types of antidepressants. Neurotransmitter systems can be visualized in the brain using positron emission tomography (PET). Additionally, brain structure and function can be studied using magnetic resonance imaging (MRI). For the visualization of dopamine synthesis in the brain, the radioligand [18F]FDOPA can be used in PET measurements. To assess task-relevant changes of diverse radioligands and thus specific metabolic processes in the brain during specific tasks, a recently developed PET-approach can be used which has already been successfully applied in a pilot study with healthy volunteers. In the present project, 60 depressed subjects and 30 healthy controls will undergo PET/MR-imaging twice. Depressed subjects will be assigned to 1 of 2 treatment groups. 30 depressive subjects will receive bupropion, the other 30 patients will be treated with escitalopram. After a treatment period of 6 weeks, the 2nd PET measurement will be performed in all participants, aiming to detect potential reward-specific changes of dopamine synthesis. The investigators hypothesize that reward-specific changes of dopamine synthesis will be lower in depressed subjects than in healthy controls, that reward-specific changes of dopamine synthesis will be significantly higher in the bupropion group than in the escitalopram group, and that the changes of dopamine synthesis will be associated with functional changes in the brain (measured by simultaneous functional MRI scans). This will be the first study comparing the effects of escitalopram and bupropion on task-specific dopamine synthesis and thus on the human reward system. The study is expected to yield new insights for individual treatment concepts in the therapy of depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Double-blind, prospective, longitudinal (optional cross-over-design in selected patients)
| Arm | Type | Receives |
|---|---|---|
| Antidepressant treatment in MDD patients with bupropion | Active comparator | Drug: WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKlineBupropion 150 mg daily after baseline PET/MRI or MRI/MRS over 6-8 weeks |
| Antidepressant treatment in MDD patients with escitalopram | Active comparator | Drug: Cipralex (escitalopram)Escitalopram 10 mg daily after baseline PET/MRI or MRI/MRS over 6-8 weeks |
| Healthy Controls without antidepressant intake | No intervention | –Healthy controls will only attend imaging procedures without medication intake |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female subjects aged between 18-65 years of age
- Depressive patients: DSM-IV diagnosis of MDD following SCID I, HDRS29, MADRS and BDI-II
- Satisfactory general health as determined by past medical history, physical examination, vital signs at screening
- Vital signs measured after 3 minutes resting in the supine position must be within the following ranges: oral body temperature between 35.0-37.5 °C, systolic blood pressure 90-140 mmHg, diastolic blood pressure 50-90 mm Hg, pulse rate 40-100 bpm
- Subjects must weigh 50-100 kg to participate in this study with a BMI within 19-26.
Key exclusion criteria (19 listed)
- Depressed patients: Presence of any severe / unstable neurological, somatic or psychiatric comorbidity
- Healthy controls: Any psychiatric disease or any severe / unstable neurological or somatic disease
- Presence of psychotic symptoms
- Acute suicidality
- Any contraindication for magnetic resonance or PET imaging
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 |
|---|---|---|
| WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKlineBupropion 150 mg daily after baseline PET/MRI or MRI/MRS over 6-8 weeks | Drug | Antidepressant treatment in MDD patients with bupropion |
| Cipralex (escitalopram)Escitalopram 10 mg daily after baseline PET/MRI or MRI/MRS over 6-8 weeks | Drug | Antidepressant treatment in MDD patients with escitalopram |
Primary outcome
Changes of the reward specific dopamine synthesis rate in the nucleus accumbens of depressed individuals after 6-8 weeks of antidepressant intake assessed via functional PET
Time frame: 6-8 weeks
Reward-specific dopamine synthesis rate: Assessment of the net influx constant Ki in the nucleus accumbens via functional PET using [18F]FDOPA as an index of the dopamine synthesis rate
Relationship between potential changes of the reward-specific dopamine synthesis rate in the nucleus accumbens assessed via functional PET and treatment response in depressed individuals after 6-8 weeks of antidepressant intake
Time frame: 6-8 weeks
Reward-specific dopamine synthesis rate: Assessment of the net influx constant Ki in the nucleus accumbens via functional PET using [18F]FDOPA as an index of the dopamine synthesis rate; Treatment response rates will be assessed at baseline and after 6-8 weeks of antidepressant therapy via the Hamilton Depression Rating Scale with 29 items (HDRS29) and the Montgomery-Åsberg Depression Rating Scale (MADRS).
Difference in changes to the reward-specific dopamine synthesis rate in the nucleus accumbens assessed via functional PET in depressed patients taking bupropion vs. escitalopram after 6-8 weeks of therapy
Time frame: 6-8 weeks
Reward-specific dopamine synthesis rate: Assessment of the net influx constant Ki in the nucleus accumbens via functional PET using [18F]FDOPA as an index of the dopamine synthesis rate
3 secondary outcomes
Relationship between the reward-specific dopamine synthesis rate (assessed via functional PET) and fMRI activation across healthy volunteers and depressed patients, both at baseline and after 6-8 weeks of therapy
Time frame: 6-8 weeks
Remission rates in depressed patients being treated with either escitalopram or bupropion in a longitudinal design
Time frame: 6-8 weeks
Test-retest reliability for the quantification of dopamine synthesis rates in healthy volunteers via functional PET
Time frame: 6-8 weeks
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 5 Nov 2024.
- Results publication: PubMed 38676734Reed MB, Handschuh PA, Schmidt C, Murgas M, Gomola D, Milz C, Klug S, Eggerstorfer B, Aichinger L, Godbersen GM, Nics L, Traub-Weidinger T, Hacker M, Lanzenberger R, Hahn A. Validation of cardiac image-derived input functions for functional PET quantification. Eur J Nucl Med Mol Imaging. 2024 Jul;51(9):2625-2637. doi: 10.1007/s00259-024-06716-8. Epub 2024 Apr 27.
- Derived from this study: PubMed 42264114Schlosser G, Handschuh PA, Murgas M, Graf S, Milz C, Klug S, Falb P, Schmidt C, Eggerstorfer B, Briem E, Mayerweg A, Artmeier L, Godbersen GM, Nics L, Rasul S, Hacker M, Hahn A, Lanzenberger R, Reed MB. Test-retest reliability of dopaminergic fPET and fMRI measures during reward processing. Neuroimage. 2026 Sep;338:122047. doi: 10.1016/j.neuroimage.2026.122047. Epub 2026 Jun 9.
- Related InfoLink provided by the sponsor.
- 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.
Rupert Lanzenberger, Univ.-Prof. Priv.-Doz. Dr. contact
Patricia Anna Handschuh, Dr.med.univ., BA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing WELLBUTRIN SR (Bupropion HCI) Sustained-Release Tablets, 150 mg; GlaxoSmithKline and Cipralex (escitalopram) in people with Major Depressive Disorder (MDD), run by Medical University of Vienna at 1 site in Austria.
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 9 inclusion and 19 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 5 Nov 2024. 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 Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Rupert Lanzenberger, Univ.-Prof. Priv.-Doz. Dr. (+43 1 40400 35760, rupert.lanzenberger@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of the reward specific dopamine synthesis rate in the nucleus accumbens of depressed individuals after 6-8 weeks of antidepressant intake assessed via functional PET (time frame: 6-8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06675851, which also lists 2 linked publications.
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 5 Nov 2024.