PsychosisNCT05455593
Effectiveness of the Combination of Water Aerobics and Metacognitive Training
A study testing Water aerobics, Metacognitive Training (MCT) and Combined intervention in people with Psychosis, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial summary
The objective of this study is to assess the efficacy of a combined intervention of water aerobics and Metacognitive Training (MCT), compared to each intervention separately, in people with psychosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Water aerobics, Metacognitive Training (MCT) and Combined intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 2 Aug 2021to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Presence of one of the following diagnoses according to DSM-V criteria: schizophrenia, unspecific psychotic disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, schizophreniform disorder.
- Psychopatological stability
- 18 to 55 years old
- Interested in participating in both water aerobics and MCT groups
Who cannot join
- Head injury or intellectual disabillity (premorbid IQ <=70)
- Present scores on the PANSS >=5 in hostility, lack of cooperation or suspiciousness, to guarantee a good relationship in the group
- Patients with substance dependence disorder
- Problems related to water activities (phobia, severe mobility problems...)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Parc Sanitari Sant Joan de Déu
Sant Boi de Llobregat, Barcelona, 08830
Susana Ochoa, PhD, 936406350 ext. 12538, susana.ochoa@sjd.es
About this study
Official title: Efficacy of the Combination of Water Aerobics and Metacognitive Training (MCT) on Psychological and Physical Health Variables and Their Relationship With SP1 and SP4 Biomarkers in People With Psychosis
The objective of this study is to assess the efficacy of a combined intervention of water aerobics and Metacognitive Training (MCT), compared to each intervention separately, in people with psychosis. One purpose is to analyze the improvement of clinical, cognitive, metacognitive and psychosocial variables, motor coordination and physical health condition. Another purpose is to study the changes in SP1 and SP4 biomarker transcription levels as a function of the intervention received. The hypothesis is that the combined intervention will enhance the benefits of each intervention separately, specifically in symptoms, cognition, metacognition and psychosocial variables.
- Conditions
- Psychosis
- Being tested
- Water aerobics, Metacognitive Training (MCT), Combined intervention
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Water aerobicsBehavioural
1-hour session of water aerobics per week, for 3 months. A specialized trainer will carry out water aerobics sessions and will focus on motor coordination, strength and cardiovascular workout.
Metacognitive Training (MCT)Behavioural
1-hour session of MCT per week, for 3 months. A trained psychologist will carry out the MCT sessions. MCT addresses the most common cognitive biases in psychosis. Each session will focus on one topic, such as attributional style, jumping to conclusions, theory of mind, emotion recognition, memory or empathy.
Combined interventionBehavioural
Patients in this arm will participate in both in water aerobics and MCT sessions, once a week for each intervention.
| Study group | Role | What they receive |
|---|---|---|
| Water aerobics | Active comparator | Aerobic exercises performed in a swimming pool. Receives: Behavioral: Water aerobics |
| Metacognitive Training (MCT) | Active comparator | Treatment program for psychosis based on Cognitive-behavioral therapy (CBT), cognitive remediation (CRT) and psychoeducation. Receives: Behavioral: Metacognitive Training (MCT) |
| Combined intervention (water aerobics + MCT) | Experimental | Combination of water aerobics and MCT sessions. Receives: Behavioral: Combined intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline BCIS Beck Cognitive Insight Scale at 3 months (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
Cognitive insight self-registered measure (15 items): ability to analyze one's own beliefs and judgments. Self-reflectivness subscale: higher scores indicate a greater ability to reflect on one's own thoughts. Selfcertainty subscale: higher scores indicate a greater tendency to overestimate one's own beliefs without considering alternative explanations. Composite index: higher scores indicate a greater cognitive insight.
Measured: Baseline and 3-month follow-up
Change from Baseline Beads Task at 3 months (Brett-Jones et al., 1987)
Measure of jumping to conclusions bias. It includes two tasks in which two jars with colored beads are presented. The first task has a 85:15 proportion and the second task has a 60:40 proportion. In the third task, the jars contain positive and negative comments, with a proportion of 60:40 in each jar. The person has to infer from which jar the beads or comments are drawn. Jumping to conclusions bias is present when the participant decides after seeing up to two beads or comments.
Measured: Baseline and 3-month follow-up
Change from Baseline CBQ Cognitive Bias Questionnaire at 3 months (Peters et al, 2013; Gutiérrez-Zotes, 2021)
Measure of five cognitive biases (30 items): jumping to conclusions, intentionalising, catastrophising, emotional reasoning, and dichotomous thinking.
Measured: Baseline and 3-month follow-up
Change from Baseline Stress Test at 3 months
Assessment of clinical and sports records, cardiorespiratory and locomotor system examination, electrocardiogram and ergometry.
Measured: Baseline and 3-month follow-up
Change from Baseline Molecular measures at 3 months
Protein levels of SP1 and SP4 biomarkers transcription factor levels in peripheral blood mononuclear cells (PBMCs). mRNA expression levels of SP1 and SP4 biomarkers transcription factors in PBMCs.
Measured: Baseline and 3-month follow-up
Secondary outcomes (25)
Change from Baseline PANSS Positive and Negative Syndrome Scale at 3 months (Kay et al., 1987; Peralta y Cuesta, 1995)
Semi-structured interview to assess positive, negative and general symptoms of psychosis. Higher scores indicate greater severity of symptoms.
Measured: Baseline and 3-month follow-up
Change from Baseline BDI-II Beck Depression Inventory-II at 3 months (Beck et al., 1996)
Depressive symptoms
Measured: Baseline and 3-month follow-up
Change from Baseline Rosenberg self-esteem scale at 3 months (Martín Albó et al, 2007)
Self-esteem measure with 10 items (scores 0 to 30). Higher scores indicate greater self-esteem. Scores below 15 may indicate problematic low self-esteem.
Measured: Baseline and 3-month follow-up
Change from Baseline IPSAQ Internal, Personal and Situational Attributions Questionnaire at 3 months (McArthur, 1972; Bentall et al, 1991; Diez-Alegría, 2006)
Attributional Style, including externalizing and personalizing bias subscales.
Measured: Baseline and 3-month follow-up
Change from Baseline Hinting Task at 3 months (Corcoran, Mercer & Frith, 1995)
Theory of mind
Measured: Baseline and 3-month follow-up
Change from Baseline Faces test at 3 months (Baron Cohen, 1997; Huerta-Ramos et al., 2021)
Facial emotion recognition
Measured: Baseline and 3-month follow-up
Change from Baseline MATRICS Consensus Cognitive Battery at 3 months (Nuechterlein et al., 2008; Rodriguez-Jimenez et al., 2012)
Verbal processing speed, verbal fluency, attention, working memory, verbal learning and memory, visual learning and memory, reasoning, problem solving.
Measured: Baseline and 3-month follow-up
WAIS-IV (Weschler Adults Intelligence Scale, 1955)
Premorbid IQ assessed with the Vocabulary subscale
Measured: Baseline
Change from Baseline GAF Global Assessment of Functioning at 3 months (Endicot et al., 1976)
General functioning in a scale of 0-100
Measured: Baseline and 3-month follow-up
Change from Baseline WHO-DAS 12, Psychiatric Disability Assessment Schedule at 3 months (WHO, 1988; Vázquez-Barquero JL, 2000)
Self-administered 12-item disability assessment
Measured: Baseline and 3-month follow-up
Change from Baseline SSQ Self Stigma Questionnaire at 3 months (Ochoa et al., 2015)
Self-administered 14-item scale to assess self-stigma
Measured: Baseline and 3-month follow-up
Change from Baseline EuroQoL EQ-5D at 3 months (Badia et al., 1999)
Self-administered 5-item to assess general quality of life
Measured: Baseline and 3-month follow-up
Change from Baseline SUMD Scale to Assess Unawareness of Mental Disorder at 3 months (Amador X.F., et al.; 1993; Ruiz A., et al., 2008)
3 items to assess awareness of having a mental illness, awareness of medication effects and awareness of social consequences of having a mental illness, in a scale of 0-15. Higher scores mean a worse outcome.
Measured: Baseline and 3-month follow-up
Change from Heart Rate at 3 months
Beats per minute (bpm)
Measured: Baseline and 3-month follow-up
Change from Blood Pressure at 3 months
Millimetre of mercury (mmHg)
Measured: Baseline and 3-month follow-up
Change from Weight at 3 months
Kilogram (Kg)
Measured: Baseline and 3-month follow-up
Change from Height at 3 months
Centimetre (cm)
Measured: Baseline and 3-month follow-up
Change from Body Mass Index (BMI) at 3 months
Weight and height will be combined to report BMI in kg/m^2
Measured: Baseline and 3-month follow-up
Change from Body Abdominal Girth at 3 months
Centimetre (cm)
Measured: Baseline and 3-month follow-up
Change from Glucose Levels at 3 months
Milligrams per decilitre (mg/dL)
Measured: Baseline and 3-month follow-up
Change from Total Cholesterol at 3 months
Milligrams per decilitre (mg/dL)
Measured: Baseline and 3-month follow-up
Change from HDL Cholesterol at 3 months
Milligrams per decilitre (mg/dL)
Measured: Baseline and 3-month follow-up
Change from LDL Cholesterol at 3 months
Milligrams per decilitre (mg/dL)
Measured: Baseline and 3-month follow-up
Change from International Physical Activity Questionnaire (IPAQ; Booth, 2000) at 3 months
Intensity of physical activity and sitting time
Measured: Baseline and 3-month follow-up
Change from Oviedo Sleep Questionnaire (OSQ; Bobes et al., 2000) at 3 months
Sleep quality
Measured: Baseline and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study start2 Aug 2021
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Parc Sanitari Sant Joan de Déu, Solidaritat Sant Joan de Déu, Fluidra
- Responsible party
- Sponsor
- Investigators
- Susana Ochoa, PhD, Principal investigator, Parc Sanitari Sant Joan de Deu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455593
- Sponsor's protocol ID
- PIC-155-21
- Status last verified
- Aug 2024
- First submitted
- 13 Jun 2022
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ochoa S, Verdaguer-Rodriguez M, Batlle N, Garreta F, Garcia B, Haro JM, Vila-Andreu E, Hernandez MJ, Escandell MJ, Munoz A, Vilamala S, Marcos S, Bassolas L, Pascua M, Ramos B; Thalassa Research Group. Efficacy of the combination of water aerobics and metacognitive training on psychological and physical health variables and their relationship with SP1 and SP4 biomarkers in people with psychosis: a study protocol. Front Psychol. 2024 Jun 11;15:1360004. doi: 10.3389/fpsyg.2024.1360004. eCollection 2024.
PubMed 38919799
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Combination of Water Aerobics and Metacognitive Training (MCT) on Psychological and Physical Health Variables and Their Relationship With SP1 and SP4 Biomarkers in People With Psychosis
- ClinicalTrials.gov ID
- NCT05455593
- Acronym / sponsor ID
- PIC-155-21
- Conditions
- Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Parc Sanitari Sant Joan de Déu, Solidaritat Sant Joan de Déu, Fluidra
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the efficacy of a combined intervention of water aerobics and Metacognitive Training (MCT), compared to each intervention separately, in people with psychosis. One purpose is to analyze the improvement of clinical, cognitive, metacognitive and psychosocial variables, motor coordination and physical health condition. Another purpose is to study the changes in SP1 and SP4 biomarker transcription levels as a function of the intervention received. The hypothesis is that the combined intervention will enhance the benefits of each intervention separately, specifically in symptoms, cognition, metacognition and psychosocial variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Water aerobics | Active comparator | Behavioral: Water aerobicsAerobic exercises performed in a swimming pool. |
| Metacognitive Training (MCT) | Active comparator | Behavioral: Metacognitive Training (MCT)Treatment program for psychosis based on Cognitive-behavioral therapy (CBT), cognitive remediation (CRT) and psychoeducation. |
| Combined intervention (water aerobics + MCT) | Experimental | Behavioral: Combined interventionCombination of water aerobics and MCT sessions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Presence of one of the following diagnoses according to DSM-V criteria: schizophrenia, unspecific psychotic disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, schizophreniform disorder.
- Psychopatological stability
- 18 to 55 years old
- Interested in participating in both water aerobics and MCT groups
Key exclusion criteria (4 listed)
- Head injury or intellectual disabillity (premorbid IQ <=70)
- Present scores on the PANSS >=5 in hostility, lack of cooperation or suspiciousness, to guarantee a good relationship in the group
- Patients with substance dependence disorder
- Problems related to water activities (phobia, severe mobility problems...)
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 |
|---|---|---|
| Water aerobics1-hour session of water aerobics per week, for 3 months. A specialized trainer will carry out water aerobics sessions and will focus on motor coordination, strength and cardiovascular workout. | Behavioural | Water aerobics |
| Metacognitive Training (MCT)1-hour session of MCT per week, for 3 months. A trained psychologist will carry out the MCT sessions. MCT addresses the most common cognitive biases in psychosis. Each session will focus on one topic, such as attributional style, jumping to conclusions, theory of mind, emotion recognition, memory or empathy. | Behavioural | Metacognitive Training (MCT) |
| Combined interventionPatients in this arm will participate in both in water aerobics and MCT sessions, once a week for each intervention. | Behavioural | Combined intervention (water aerobics + MCT) |
Primary outcome
Change from Baseline BCIS Beck Cognitive Insight Scale at 3 months (Beck et al., 2004; Gutierrez-Zotes et al., 2012)
Time frame: Baseline and 3-month follow-up
Cognitive insight self-registered measure (15 items): ability to analyze one's own beliefs and judgments. Self-reflectivness subscale: higher scores indicate a greater ability to reflect on one's own thoughts. Selfcertainty subscale: higher scores indicate a greater tendency to overestimate one's own beliefs without considering alternative explanations. Composite index: higher scores indicate a greater cognitive insight.
Change from Baseline Beads Task at 3 months (Brett-Jones et al., 1987)
Time frame: Baseline and 3-month follow-up
Measure of jumping to conclusions bias. It includes two tasks in which two jars with colored beads are presented. The first task has a 85:15 proportion and the second task has a 60:40 proportion. In the third task, the jars contain positive and negative comments, with a proportion of 60:40 in each jar. The person has to infer from which jar the beads or comments are drawn. Jumping to conclusions bias is present when the participant decides after seeing up to two beads or comments.
Change from Baseline CBQ Cognitive Bias Questionnaire at 3 months (Peters et al, 2013; Gutiérrez-Zotes, 2021)
Time frame: Baseline and 3-month follow-up
Measure of five cognitive biases (30 items): jumping to conclusions, intentionalising, catastrophising, emotional reasoning, and dichotomous thinking.
Change from Baseline Stress Test at 3 months
Time frame: Baseline and 3-month follow-up
Assessment of clinical and sports records, cardiorespiratory and locomotor system examination, electrocardiogram and ergometry.
Change from Baseline Molecular measures at 3 months
Time frame: Baseline and 3-month follow-up
Protein levels of SP1 and SP4 biomarkers transcription factor levels in peripheral blood mononuclear cells (PBMCs). mRNA expression levels of SP1 and SP4 biomarkers transcription factors in PBMCs.
25 secondary outcomes
Change from Baseline PANSS Positive and Negative Syndrome Scale at 3 months (Kay et al., 1987; Peralta y Cuesta, 1995)
Time frame: Baseline and 3-month follow-up
Change from Baseline BDI-II Beck Depression Inventory-II at 3 months (Beck et al., 1996)
Time frame: Baseline and 3-month follow-up
Change from Baseline Rosenberg self-esteem scale at 3 months (Martín Albó et al, 2007)
Time frame: Baseline and 3-month follow-up
Change from Baseline IPSAQ Internal, Personal and Situational Attributions Questionnaire at 3 months (McArthur, 1972; Bentall et al, 1991; Diez-Alegría, 2006)
Time frame: Baseline and 3-month follow-up
Change from Baseline Hinting Task at 3 months (Corcoran, Mercer & Frith, 1995)
Time frame: Baseline and 3-month follow-up
Change from Baseline Faces test at 3 months (Baron Cohen, 1997; Huerta-Ramos et al., 2021)
Time frame: Baseline and 3-month follow-up
Change from Baseline MATRICS Consensus Cognitive Battery at 3 months (Nuechterlein et al., 2008; Rodriguez-Jimenez et al., 2012)
Time frame: Baseline and 3-month follow-up
WAIS-IV (Weschler Adults Intelligence Scale, 1955)
Time frame: Baseline
Change from Baseline GAF Global Assessment of Functioning at 3 months (Endicot et al., 1976)
Time frame: Baseline and 3-month follow-up
Change from Baseline WHO-DAS 12, Psychiatric Disability Assessment Schedule at 3 months (WHO, 1988; Vázquez-Barquero JL, 2000)
Time frame: Baseline and 3-month follow-up
Change from Baseline SSQ Self Stigma Questionnaire at 3 months (Ochoa et al., 2015)
Time frame: Baseline and 3-month follow-up
Change from Baseline EuroQoL EQ-5D at 3 months (Badia et al., 1999)
Time frame: Baseline and 3-month follow-up
Change from Baseline SUMD Scale to Assess Unawareness of Mental Disorder at 3 months (Amador X.F., et al.; 1993; Ruiz A., et al., 2008)
Time frame: Baseline and 3-month follow-up
Change from Heart Rate at 3 months
Time frame: Baseline and 3-month follow-up
Change from Blood Pressure at 3 months
Time frame: Baseline and 3-month follow-up
Change from Weight at 3 months
Time frame: Baseline and 3-month follow-up
Change from Height at 3 months
Time frame: Baseline and 3-month follow-up
Change from Body Mass Index (BMI) at 3 months
Time frame: Baseline and 3-month follow-up
Change from Body Abdominal Girth at 3 months
Time frame: Baseline and 3-month follow-up
Change from Glucose Levels at 3 months
Time frame: Baseline and 3-month follow-up
Change from Total Cholesterol at 3 months
Time frame: Baseline and 3-month follow-up
Change from HDL Cholesterol at 3 months
Time frame: Baseline and 3-month follow-up
Change from LDL Cholesterol at 3 months
Time frame: Baseline and 3-month follow-up
Change from International Physical Activity Questionnaire (IPAQ; Booth, 2000) at 3 months
Time frame: Baseline and 3-month follow-up
Change from Oviedo Sleep Questionnaire (OSQ; Bobes et al., 2000) at 3 months
Time frame: Baseline and 3-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Derived from this study: PubMed 38919799Ochoa S, Verdaguer-Rodriguez M, Batlle N, Garreta F, Garcia B, Haro JM, Vila-Andreu E, Hernandez MJ, Escandell MJ, Munoz A, Vilamala S, Marcos S, Bassolas L, Pascua M, Ramos B; Thalassa Research Group. Efficacy of the combination of water aerobics and metacognitive training on psychological and physical health variables and their relationship with SP1 and SP4 biomarkers in people with psychosis: a study protocol. Front Psychol. 2024 Jun 11;15:1360004. doi: 10.3389/fpsyg.2024.1360004. eCollection 2024.
- Individual participant dataSharing planned: Undecided
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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.
Susana Ochoa, PhD principal investigator
Parc Sanitari Sant Joan de Deu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water aerobics, Metacognitive Training (MCT) and Combined intervention in people with Psychosis, run by Fundació Sant Joan de Déu 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susana Ochoa, PhD (936406350 ext. 12538, susana.ochoa@sjd.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline BCIS Beck Cognitive Insight Scale at 3 months (Beck et al., 2004; Gutierrez-Zotes et al., 2012) (time frame: Baseline and 3-month follow-up). The study lists 5 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 NCT05455593, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.