Schizophrenia and Disorders With Psychotic FeaturesAGES-MindNCT03309475
Effectiveness of a Mindfulness-based Group Training Addressing Social Cognition in First Episode Psychosis (AGES-Mind)
A study testing SocialMIND, Psychoeducational multicomponent intervention and Psychosocial treatment in people with Schizophrenia and Disorders With Psychotic Features and Psychotic Episode, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
The current investigation aims to compare two group intervention in patients with a first episode of psychosis, that is, people who have suffered their first psychotic episode within 5 years prior to their inclusion in the study. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia and Disorders With Psychotic Features, Psychotic Episode
- What is being tested?
- SocialMIND, Psychoeducational multicomponent intervention and Psychosocial treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2018to 31 Jan 2023
- 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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-45 years old
- First hospitalization, first visit to mental health services with positive symptoms, onset of antipsychotic treatment, or first appearance of positive symptoms confirmed by an informant within the period of five years prior to the enrolment in the study;
- Informed consent given
Who cannot join
- Clinical Global Impression (CGI) higher than 5 ("markedly ill")
- Other Axis I diagnoses, except for substance use if psychotic symptoms remain at least 14 days after negative urine test.
- Intellectual disability plus impaired global functioning prior to disorder onset
- Generalized development disorder
- Pregnancy
- Attendance to either mindfulness programs or structured psychoeducational interventions at the time of the enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness-based Social Cognition Group Training (SocialMIND) Versus Psychoeducational Multicomponent Intervention in Patients With a First Episode of Psychosis (AGES-Mind Study): A Randomized Controlled Trial
The current investigation aims to compare two group intervention in patients with a first episode of psychosis, that is, people who have suffered their first psychotic episode within 5 years prior to their inclusion in the study. The experimental arm is a mindfulness-based social cognition training (SocialMind) designed by professionals with both formal training and clinical experience in the field of mindfulness and third generation cognitive-behavioral therapies. The active comparator arm is a psychoeducation program specifically designed for individuals with recent onset psychosis by members of the team with great experience in delivering such interventions. The main outcome is social functioning, as measured by the Personal and Social Performance Scale (PSP), an instrument developed for psychotic patients. The main hypothesis is that the improvement in social functioning will be larger among the participants on the experimental arm, because there is enough evidence suggesting that deficits in social cognition are present even in the first stages of psychotic syndrome and related to social functioning and general disability. Moreover, mindfulness-based interventions have proven themselves effective in other severe mental disorders.
Read the detailed description
Social functioning is impaired among many patients with a first episode of psychosis, who also show a lower ability to recognize, understand and benefit from social stimuli (i.e., deficits in social cognition) than their pairs. Both deficits underlie the general functional impairment found across non-affective psychotic syndromes. Since currently available pharmacological strategies have not proven themselves effective in addressing this matter, new psychotherapeutic approaches should be developed. Investigators' main hypothesis is that a mindfulness-based social cognition group training (SocialMind) will improve social and general functioning, and that this improvement will be higher in the SocialMind than in the psychoeducation group. Given the association between oxidative stress and cognitive functioning, a relationship between oxidative stress biomarkers and intervention-related variables is also expected.
A research team with more than ten mental health professionals and many collaborators will carry and oversee the assessment sessions. A Pharmacology Department will analyse the biological samples. Regulated-trained, well-experienced clinicians will design and administer both interventions. The whole team will take part in the process of scientific publication and results dissemination.
- Being tested
- SocialMIND, Psychoeducational multicomponent intervention, Psychosocial treatment, Psychotropic treatment
- Keywords
- first episode psychosis, early psychosis, schizophrenia, mindfulness, social cognition, social functioning, AGES-Mind, SocialMind
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders, Psychotic Disorders, Schizophrenia, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SocialMINDBehavioural
Also called Mindfulness-based social cognition training, Mindfulness-based social cognition group training, MB-SCT
SocialMind is a mindfulness-based intervention including elements such as radical acceptance, decentering or meditation-techniques. It is designed to target social cognition, defined as the ability to recognize, understand and benefit from social stimuli.
Psychoeducational multicomponent interventionBehavioural
Also called PMI, Structured psychoeducational group, Psychoeducational group, Psychoeducation group
The psychoeducational multicomponent intervention addresses and discuss several aspects of great importance for persons who suffer a first episode of psychosis, such as biased perception and thinking, delusions-related anxiety or the nature of hallucinations. Its aim is to encourage patients to reflect upon their experiences from a critic perspective.
Psychosocial treatmentBehavioural
Treatment as usual delivered by patient's practitioner
Psychotropic treatmentDrug
Also called Drug treatment
Treatment as usual delivered by patient's practitioner
| Study group | Role | What they receive |
|---|---|---|
| SocialMIND | Experimental | The experimental arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and mindfulness-based social cognition group training (SocialMind), specifically designed for patients with first episode psychosis by the research team. There will be a first phase (intensive intervention) consisting of 8 weekly sessions and a second phase (follow-up sessions) consisting of 4 fortnightly sessions and 5 monthly sessions. Receives: Behavioral: SocialMIND; Behavioral: Psychosocial treatment; Drug: Psychotropic treatment |
| Psychoeducational Multicomponent Intervention | Active comparator | The active comparator arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and a psychoeducational multicomponent intervention for psychosis.There will be a first phase (intensive intervention) consisting of 8 weekly sessions and a second phase (follow-up sessions) consisting of 4 fortnightly sessions and 7 monthly sessions. Receives: Behavioral: Psychoeducational multicomponent intervention; Behavioral: Psychosocial treatment; Drug: Psychotropic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in social functioning
Personal and Social Performance Scale (PSP) measures patient's functioning on different social areas, such as self-care, relationships, social activities and aggressive behavior.
Measured: 8, 16, 36 and 48 weeks
Secondary outcomes (13)
Change in global functioning
Global Assessment of Functioning Scale (GAF) measures patient's general functioning using a single 0-100 scale.
Measured: 8, 16, 36 and 48 weeks
Change in quality of life
WHOQOL-BREF measures patient's quality of life according to World Health Organization parameters.
Measured: 8, 16, 36 and 48 weeks
Change in clinical global impression
Clinical Global Impression Scale for Schizophrenia (CGI-SCH) measures patients' clinical state and clinical change over time
Measured: 8, 16, 36 and 48 weeks
Change in psychotic symptoms
Positive and Negative Symptoms Scale for Schizophrenia (PANSS) measures psychotic syndrome through a detailed clinical interview.
Measured: 8, 16, 36 and 48 weeks
Change in depressive symptoms
Calgary Depression Scale for Schizophrenia (CDSS) measures depressive symptoms in psychotic patients through a personal interview
Measured: 8, 16, 36 and 48 weeks
Change in anxiety symptoms
Beck Anxiety Inventory (BAI) measures clinical anxiety through 21 items.
Measured: 8, 16, 36 and 48 weeks
Change in social cognition
Hinting task, Reading the Mind in the Eyes Test (RMET), Emotion Recognition task (ER-40) and Ambiguous Intentions and Attribution Questionnaire (AIHQ) measure main domains of social cognition.
Measured: 8, 16, 36 and 48 weeks
Change in reflective functioning
Reflective Functioning Questionnaire (RFQ-8) measures mentalization ability through a set of 8 questions
Measured: 8, 16, 36 and 48 weeks
Change in emotional intelligence
Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT v2.0) measures emotional intelligence through a set of questions referred to different situations.
Measured: 8, 16, 36 and 48 weeks
Change in mindful attention and awareness
Mindfulness Attention Awareness Scale (MAAS) measures processes thought to be related to clinical outcomes in mindfulness-based interventions.
Measured: 8, 16, 36 and 48 weeks
Change in cognitive insight
Beck Cognitive Insight Scale (BCIS) explores self-reflection and self-certainty, as parts of the cognitive insight construct
Measured: 8, 16, 36 and 48 weeks
Change in neurocognition
Four tasks of the Matrics Consensus Cognitive Battery (MCCB) measure different domains of neurocognition (symbol coding, letter number span, spatial span and CPT-IP)
Measured: 8, 16, 36 and 48 weeks
Change in oxidative stress and anti-inflammatory response
Total antioxidant status, enzymatic activity and cytokines
Measured: 8 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start1 Sep 2018
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia and Disorders With Psychotic FeaturesStudies 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
- Model description
- Pilot, multi-center, rater-blinded, prospective (48-weeks follow-up), randomized, controlled (versus active comparator \[psychoeducation\]), clinical trial. The experimental arm will receive treatment as usual (both drug and psychosocial therapy) and mindfulness-based social cognition group training, specifically designed for patients with first episode psychosis by the research team. The active comparator arm will receive treatment as usual (both drug and psychosocial therapy) and psychoeducation group training for psychosis.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Carlos III Health Institute, European Regional Development Fund
- Responsible party
- Sponsor
- Investigators
- Maria Fe Bravo, MD, PhD, Principal investigator, Instituto para la Investigación Biomédica del Hospital universitario La Paz (IdiPAZ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309475
- Sponsor's protocol ID
- AGES-Mind
- Acronym
- AGES-Mind
- Status last verified
- Oct 2023
- First submitted
- 27 Sep 2017
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be available on request.
Publications
Fond G, d'Albis MA, Jamain S, Tamouza R, Arango C, Fleischhacker WW, Glenthoj B, Leweke M, Lewis S, McGuire P, Meyer-Lindenberg A, Sommer IE, Winter-van Rossum I, Kapur S, Kahn RS, Rujescu D, Leboyer M. The promise of biological markers for treatment response in first-episode psychosis: a systematic review. Schizophr Bull. 2015 May;41(3):559-73. doi: 10.1093/schbul/sbv002. Epub 2015 Mar 10.
PubMed 25759473Brune M. "Theory of mind" in schizophrenia: a review of the literature. Schizophr Bull. 2005 Jan;31(1):21-42. doi: 10.1093/schbul/sbi002. Epub 2005 Feb 16.
PubMed 15888423Lecomte T, Corbiere M, Ehmann T, Addington J, Abdel-Baki A, Macewan B. Development and preliminary validation of the First Episode Social Functioning Scale for early psychosis. Psychiatry Res. 2014 May 30;216(3):412-7. doi: 10.1016/j.psychres.2014.01.044. Epub 2014 Feb 5.
PubMed 24613006Mediavilla R, Munoz-Sanjose A, Rodriguez-Vega B, Bayon C, Palao A, Lahera G, Sanchez-Castro P, Roman E, Cebolla S, de Diego A, Pastor JM, Bravo-Ortiz MF. Mindfulness-based social cognition training (SocialMIND) versus psychoeducational multicomponent intervention for people with a first episode of psychosis: a study protocol for a randomised controlled trial. BMC Psychiatry. 2019 Jul 29;19(1):233. doi: 10.1186/s12888-019-2206-4.
PubMed 31357965
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Social Cognition Group Training (SocialMIND) Versus Psychoeducational Multicomponent Intervention in Patients With a First Episode of Psychosis (AGES-Mind Study): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03309475
- Acronym / sponsor ID
- AGES-Mind / AGES-Mind
- Keywords
- first episode psychosis, early psychosis, schizophrenia, mindfulness, social cognition, social functioning, AGES-Mind, SocialMind
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Carlos III Health Institute, European Regional Development Fund
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 13 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current investigation aims to compare two group intervention in patients with a first episode of psychosis, that is, people who have suffered their first psychotic episode within 5 years prior to their inclusion in the study. The experimental arm is a mindfulness-based social cognition training (SocialMind) designed by professionals with both formal training and clinical experience in the field of mindfulness and third generation cognitive-behavioral therapies. The active comparator arm is a psychoeducation program specifically designed for individuals with recent onset psychosis by members of the team with great experience in delivering such interventions. The main outcome is social functioning, as measured by the Personal and Social Performance Scale (PSP), an instrument developed for psychotic patients. The main hypothesis is that the improvement in social functioning will be larger among the participants on the experimental arm, because there is enough evidence suggesting that deficits in social cognition are present even in the first stages of psychotic syndrome and related to social functioning and general disability. Moreover, mindfulness-based interventions have proven themselves effective in other severe mental disorders.
Detailed description
Social functioning is impaired among many patients with a first episode of psychosis, who also show a lower ability to recognize, understand and benefit from social stimuli (i.e., deficits in social cognition) than their pairs. Both deficits underlie the general functional impairment found across non-affective psychotic syndromes. Since currently available pharmacological strategies have not proven themselves effective in addressing this matter, new psychotherapeutic approaches should be developed. Investigators' main hypothesis is that a mindfulness-based social cognition group training (SocialMind) will improve social and general functioning, and that this improvement will be higher in the SocialMind than in the psychoeducation group. Given the association between oxidative stress and cognitive functioning, a relationship between oxidative stress biomarkers and intervention-related variables is also expected.
A research team with more than ten mental health professionals and many collaborators will carry and oversee the assessment sessions. A Pharmacology Department will analyse the biological samples. Regulated-trained, well-experienced clinicians will design and administer both interventions. The whole team will take part in the process of scientific publication and results dissemination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot, multi-center, rater-blinded, prospective (48-weeks follow-up), randomized, controlled (versus active comparator [psychoeducation]), clinical trial. The experimental arm will receive treatment as usual (both drug and psychosocial therapy) and mindfulness-based social cognition group training, specifically designed for patients with first episode psychosis by the research team. The active comparator arm will receive treatment as usual (both drug and psychosocial therapy) and psychoeducation group training for psychosis.
| Arm | Type | Receives |
|---|---|---|
| SocialMIND | Experimental | Behavioral: SocialMIND, Behavioral: Psychosocial treatment, Drug: Psychotropic treatmentThe experimental arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and mindfulness-based social cognition group training (SocialMind), specifically designed for patients with first episode psychosis by the research team. There will be a first phase (intensive intervention) consisting of 8 weekly sessions and a second phase (follow-up sessions) consisting of 4 fortnightly sessions and 5 monthly sessions. |
| Psychoeducational Multicomponent Intervention | Active comparator | Behavioral: Psychoeducational multicomponent intervention, Behavioral: Psychosocial treatment, Drug: Psychotropic treatmentThe active comparator arm will receive treatment as usual (both psychotropic treatment and psychosocial treatment) and a psychoeducational multicomponent intervention for psychosis.There will be a first phase (intensive intervention) consisting of 8 weekly sessions and a second phase (follow-up sessions) consisting of 4 fortnightly sessions and 7 monthly sessions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-45 years old
- First hospitalization, first visit to mental health services with positive symptoms, onset of antipsychotic treatment, or first appearance of positive symptoms confirmed by an informant within the period of five years prior to the enrolment in the study;
- Informed consent given
Key exclusion criteria (6 listed)
- Clinical Global Impression (CGI) higher than 5 ("markedly ill")
- Other Axis I diagnoses, except for substance use if psychotic symptoms remain at least 14 days after negative urine test.
- Intellectual disability plus impaired global functioning prior to disorder onset
- Generalized development disorder
- Pregnancy
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 |
|---|---|---|
| SocialMINDAlso: Mindfulness-based social cognition training, Mindfulness-based social cognition group training, MB-SCTSocialMind is a mindfulness-based intervention including elements such as radical acceptance, decentering or meditation-techniques. It is designed to target social cognition, defined as the ability to recognize, understand and benefit from social stimuli. | Behavioural | SocialMIND |
| Psychoeducational multicomponent interventionAlso: PMI, Structured psychoeducational group, Psychoeducational group, Psychoeducation groupThe psychoeducational multicomponent intervention addresses and discuss several aspects of great importance for persons who suffer a first episode of psychosis, such as biased perception and thinking, delusions-related anxiety or the nature of hallucinations. Its aim is to encourage patients to reflect upon their experiences from a critic perspective. | Behavioural | Psychoeducational Multicomponent Intervention |
| Psychosocial treatmentTreatment as usual delivered by patient's practitioner | Behavioural | Psychoeducational Multicomponent Intervention, SocialMIND |
| Psychotropic treatmentAlso: Drug treatmentTreatment as usual delivered by patient's practitioner | Drug | Psychoeducational Multicomponent Intervention, SocialMIND |
Primary outcome
Change in social functioning
Time frame: 8, 16, 36 and 48 weeks
Personal and Social Performance Scale (PSP) measures patient's functioning on different social areas, such as self-care, relationships, social activities and aggressive behavior.
13 secondary outcomes
Change in global functioning
Time frame: 8, 16, 36 and 48 weeks
Change in quality of life
Time frame: 8, 16, 36 and 48 weeks
Change in clinical global impression
Time frame: 8, 16, 36 and 48 weeks
Change in psychotic symptoms
Time frame: 8, 16, 36 and 48 weeks
Change in depressive symptoms
Time frame: 8, 16, 36 and 48 weeks
Change in anxiety symptoms
Time frame: 8, 16, 36 and 48 weeks
Change in social cognition
Time frame: 8, 16, 36 and 48 weeks
Change in reflective functioning
Time frame: 8, 16, 36 and 48 weeks
Change in emotional intelligence
Time frame: 8, 16, 36 and 48 weeks
Change in mindful attention and awareness
Time frame: 8, 16, 36 and 48 weeks
Change in cognitive insight
Time frame: 8, 16, 36 and 48 weeks
Change in neurocognition
Time frame: 8, 16, 36 and 48 weeks
Change in oxidative stress and anti-inflammatory response
Time frame: 8 and 48 weeks
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 9 Jan 2024.
- Background: PubMed 25759473Fond G, d'Albis MA, Jamain S, Tamouza R, Arango C, Fleischhacker WW, Glenthoj B, Leweke M, Lewis S, McGuire P, Meyer-Lindenberg A, Sommer IE, Winter-van Rossum I, Kapur S, Kahn RS, Rujescu D, Leboyer M. The promise of biological markers for treatment response in first-episode psychosis: a systematic review. Schizophr Bull. 2015 May;41(3):559-73. doi: 10.1093/schbul/sbv002. Epub 2015 Mar 10.
- Background: PubMed 15888423Brune M. "Theory of mind" in schizophrenia: a review of the literature. Schizophr Bull. 2005 Jan;31(1):21-42. doi: 10.1093/schbul/sbi002. Epub 2005 Feb 16.
- Background: PubMed 24613006Lecomte T, Corbiere M, Ehmann T, Addington J, Abdel-Baki A, Macewan B. Development and preliminary validation of the First Episode Social Functioning Scale for early psychosis. Psychiatry Res. 2014 May 30;216(3):412-7. doi: 10.1016/j.psychres.2014.01.044. Epub 2014 Feb 5.
- Derived from this study: PubMed 31357965Mediavilla R, Munoz-Sanjose A, Rodriguez-Vega B, Bayon C, Palao A, Lahera G, Sanchez-Castro P, Roman E, Cebolla S, de Diego A, Pastor JM, Bravo-Ortiz MF. Mindfulness-based social cognition training (SocialMIND) versus psychoeducational multicomponent intervention for people with a first episode of psychosis: a study protocol for a randomised controlled trial. BMC Psychiatry. 2019 Jul 29;19(1):233. doi: 10.1186/s12888-019-2206-4.
- AGES-CM ConsortiumLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data will be available on request.
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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.
Maria Fe Bravo, MD, PhD principal investigator
Instituto para la Investigación Biomédica del Hospital universitario La Paz (IdiPAZ)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SocialMIND, Psychoeducational multicomponent intervention and Psychosocial treatment in people with Schizophrenia and Disorders With Psychotic Features and Psychotic Episode, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
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 3 inclusion and 6 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 9 Jan 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 Spain. 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 social functioning (time frame: 8, 16, 36 and 48 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 NCT03309475, which also lists 4 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 9 Jan 2024.