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SchizophreniaCORTEX-SPNCT03509597

Brain Image Markers Associated With Cognitive Training and Aerobic Exercise in Schizophrenia

A study testing Aerobic Exercise, Cognitive Training and Treatment as usual in people with Schizophrenia, run by Red Salud Mental Araba at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study evaluates the brain correlates of Cognitive Training and Aerobic Exercise in schizophrenia. A third of participants will receive Cognitive Training plus Standard Care for schizophrenia. Another third of participants will receive Aerobic Exercise Training plus Standard Care for schizophrenia. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Aerobic Exercise, Cognitive Training and Treatment as usual
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteSpain
Study dates
1 Mar 2017to 1 Jun 2020
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of Schizophrenia (DSM-5 F20.9)
  • More than 2 years since the onset of the disease.
  • Stable cognitive impairment.
  • Moderate severity of cognitive impairment in MATRICS scores (T score < 40 in, at least, 1 out of 7 cognitive domains).

Who cannot join

  • Subjects clinically unstable (PANSS positive score > 19).
  • Cognitive impairment due to another medical condition (neurocognitive disorders, brain injury, intellectual disability, etc.)

Trial locations and contacts

1 site in 1 country.

Pedro M Sanchez Gomez, MD contact

+34 945006555 ext. 6558

gomepe@mac.com

Edorta J Elizagarate Zabala, MD contact

+34 945006555

eduardojose.elizagaratezabala@osakidetza.eus

Spain1 site, 1 recruiting
  • Hospital Psiquiatrico de Alava. Red Salud Mental de Araba

    Vitoria-Gasteiz, Alava, 01006

    Pedro M. S Gomez, MD, +34 945006555 ext. 6558, gomepe@mac.com

    Edorta J Elizagarate Zabala, MD, +34 945 00 6555, eduardojose.elizagaratezabala@osakidetza.eus

    Recruiting

Other trials in Spain

About this study

Official title: A Randomized, Open-Label, Parallel-Group Study to Investigate The Effect of Cognitive Training and Aerobic Exercise on Brain, Functional Outcome and Cognition in Schizophrenia

This study evaluates the brain correlates of Cognitive Training and Aerobic Exercise in schizophrenia. A third of participants will receive Cognitive Training plus Standard Care for schizophrenia. Another third of participants will receive Aerobic Exercise Training plus Standard Care for schizophrenia. A control group will of participants will receive Standard Care plus Occupational Activities for the same duration and frequency as the experimental groups.

Read the detailed description

This study, randomized, open, controlled with schizophrenia-standard-care, is aimed to determine structural and functional brain changes associated to cognitive remediation and physical exercise in schizophrenia.

The study participants will be enrolled in the catchment area of the Hospital Psiquiatrico de Alava, in the province of Alava, Basque Region, Northern Spain.147 patients diagnosed with schizophrenia will be randomly assigned to Cognitive Training Group or Aerobic Exercise Group or a Control Group for a five-month period.

Both Cognitive Training Group patients and Aerobic Exercise Group patients will participate in training sessions of 60 min/d, 3 d/wk. Patients assigned to Control Group will receive the standard care for schizophrenia in this area plus occupational activities for the same duration and frequency than the two experimental groups.

Cognitive Training will be implemented through REHACOP, a cognitive remediation program for Spanish speaking patients with schizophrenia whose efficacy on cognitive performance and negative symptoms has already been demonstrated in patients with schizophrenia. REHACOP is a "paper \& pencil" based cognitive remediation program that covers 8 cognitive domains including social cognition. It is based on the principles of Optimization, Restauration \& Compensation.

Aerobic Exercise Training will consist of an intensive physical exercise program supervised by certified graduates and doctorate students of Physical Activity and Sport Sciences. Sessions will include 10-minute warming-up and 10-minute back exercises and stretches. The main part of the session will consist of aerobic exercise (20-minute indoor bicycle) and muscle-resistance and strength exercises for 20 minutes. The intensity of the sessions will be determined on a case by case basis according to the HR necessary to achieve the intensity ranges (R2-moderate and R3-high). During the sessions, the bicycle's power and pace will be individually adjusted to achieve the selected HR.

The assessment batteries, neuroimaging and Serum BDNF levels will be administered and determined at baseline and immediately following the completion of the Cognitive Remediation or Aerobic Exercise interventions.

Primary outcomes: Structural and functional brain changes will be assessed by MRI neuroimaging. A Philips Achieva 3.0T MRI system equipped with a modular 32-channel architecture. 3 different types of images will be acquired: a) T1-weighted MRI imaging, b) Diffusion Tensor imaging, c) fMRI imaging at rest and using a cognitive paradigm.

Secondary outcomes will be changes in cognitive performance, clinical and functional changes and Serum BDNF changes.

Conditions
Schizophrenia
Being tested
Aerobic Exercise, Cognitive Training, Treatment as usual, Occupational Activities
Keywords
Cognitive remediation, Aerobic exercise, Physical exercise, Negative symptoms, Functional outcome, Cognition
Medical subject headings
Schizophrenia, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic ExerciseBehavioural

    Physical exercise training consisting of aerobic exercise and strength/resistance training.

  • Cognitive TrainingBehavioural

    Cognitive remediation program using REHACOP rehabilitation program.

  • Treatment as usualBehavioural

    Standard care for schizophrenia + Leisure and free time activities.

  • Occupational ActivitiesBehavioural

    Engagement in activities aimed to keep patients actively involved in demanding tasks.

Study groups in NCT03509597
Study groupRoleWhat they receive
Aerobic ExerciseExperimentalThis program consists of an exercise dosage of 180 min/week administered in 3 sessions of 60 minutes. Each session includes 10 minutes of warm-up exercise before the main exercise and 10 minutes of cool-down afterwards.the principal exercise section includes 20 minutes of aerobic exercise and 20 minutes of resistance and strength exercises. The exercise intensity will be regulated according to the heart rate measured by a pulsimeter throughout the exercise. The target intensity level will be individualized according to the heart rate to set the moderate intensity level (HR values between ventilatory thresholds) and high intensity level (HR values from 2nd. ventilatory threshold to the peak threshold).
Receives: Behavioral: Aerobic Exercise
Cognitive TrainingExperimentalThe CT group participates in a cognitive remediation program. This program consists of 3 sessions of 60 minutes per week. CT will be administered in groups of 5-8 subjects. The cognitive domains involved in the CT are attention/concentration, memory/learning, language, executive functions, social cognition, social skills, daily living activities and psychoeducation. Cognitive Remediation will be provided by using REHACOP, a cognitive remediation training tool designed and validated for Spanish patients with schizophrenia.
Receives: Behavioral: Cognitive Training
Treatment as usualSham comparatorThe TaU Group receives the usual treatment that patients with schizophrenia in Spain enriched with occupational activities administered 3 times a week with a duration of 60 minutes each session.
Receives: Behavioral: Treatment as usual; Behavioral: Occupational Activities

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Grey Matter Volume Change

    Assessment of Grey Matter volume changes (T1-weighted MRI) among the 3 groups using Voxel Based Morphometry (VBM).

    Measured: 5 months

  2. Fractional Anisotropy Change

    Assessment of changes in fractional anisotropy of White Matter fibers by Diffusion Tensor MR Imaging and using the Tract-Based Spatial Statistics (TBSS).

    Measured: 5 months

  3. Functional Magnetic Resonance Imaging (fMRI) Change at Rest

    Assessment of changes in fMRI at rest with the Coon Functional Connectivity Toolbox.

    Measured: 5 months

  4. Functional Magnetic Resonance Imaging (fMRI) Change during the performance of a cognitive paradigm.

    Assessment of changes in fMRI during the performance of a cognitive paradigm with Statistical Parametric Mapping (SPM8).

    Measured: 5 months

Secondary outcomes (37)
  1. Serum BDNF

    Assessment of changes in serum BDNF using ELISA immuno-assay techniques. Measured in ng/ml.

    Measured: 5 months.

  2. Clinical Symptoms of Schizophrenia measured by the Positive and Negative Symptoms Scale (PANSS).

    Severity of the negative symptoms will be assessed with the total score of the Subscale for Negative Symptoms of the PANSS scale, which comprises 7 items, each one measuring a specific negative symptom. Each item ranges from 1 (absence of the symptom) to 7 (extreme severity of the symptom). Total score of the Negative Subscale of the PANSS ranges from 7 (minimum score) to 49 (maximum severity). Severity of positive symptoms will be assessed with the total score of the Subscale for Positive Symptoms of the PANSS, which comprises 7 items ranging from 1 (absence of the symptom) to 7 (extreme severity of the symptom). Total score of the Positive Subscale ranges from 7 (minimun score) to 49 (maximun severity). General Psychopathology will be assessed with the total score of the General Psychopathology Subscale which comprises 16 items ranging from 1(absence of the symptom) to 7 (extreme severity of the symptom).

    Measured: 5 months.

  3. Negative Symptoms of Schizophrenia measured by the Brief Negative Symptoms Scale (BNSS).

    Severity of negative symptoms will be assessed with the total score of the BNSS. Values ranges from 0 (total absence of negative symptoms) to 90 (maximum severity of negative symptoms).

    Measured: 5 months

  4. Negative Symptoms of Schizophrenia measured by the Clinical Assessment Interview for Negative Symptoms Scale (CAINS)

    Severity of negative symptoms will be assessed with the total score of the CAINS scale. Values ranges from 0 (total absence of negative symptoms) to 52 (maximum severity of negative symptoms).

    Measured: 5 months

  5. Functional Outcome measured by the UCSD Performance Based Assessment of Functional Skills in Severe Mental Illness (UPSA).

    The UPSA includes the following 5 subscales: Financial Skills, Communication, Comprehension/Planning, Transportation, Household Management. Total scores for each subscale are calculated by transforming raw scores into a 0- to-10 scale, yielding comparable scores on each scale. In order to have a 100-point summary score, each subscale score is multiplied by 2, yielding subscale scores ranging from 1 to 20. A summary UPSA score is calculated by summing these five scores, resulting in total scores ranging from 0 to 100. Scores of 0 represent maximum severity of functional impairment and a score of 100 represents total absence of functional disability.

    Measured: 5 months

  6. Functional Outcome measured by the World Health Organization Disability Assessment Schedule (WHODAS 2.0).

    The 36-item version of WHODAS 2.0 allows users to generate scores for the six domains of functioning and to calculate an overall functioning score. The scores assigned to each of the items - "none" (1), "mild" (2) "moderate" (3), "se- vere" (4) and "extreme" (5) - are summed. A score of 36 represents total absence of disability and 180 maximum severity of disability.

    Measured: 5 months

  7. Functional Outcome measured by the Short Form (36) Health Survey (SF-36).

    The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Measured: 5 months

  8. Physical Condition measured by the Modified Shuttle Walking Test

    Heart rate achieved when walking between 2 cones spaced 10 meters at an increasing rate.

    Measured: 5 months

  9. Cardiorespiratory Fitness measured with the Peak Oxygen Uptake (VO2 max)

    maximum rate of oxygen consumption measured during incremental exercise (exercise of increasing intensity)

    Measured: 5 months

  10. Weight.

    Weight in Kg

    Measured: 5 months

  11. Height

    Height in meters.

    Measured: 5 months

  12. Body composition measured with Body Mass Index (BMI)

    The BMI is defined as the body mass divided by the square of the body height, and is expressed in units of kg/m2, resulting from mass in kilograms and height in metres.

    Measured: 5 months.

  13. Abdominal Perimeter

    Abdominal perimeter measured in centimeters.

    Measured: 5 months

  14. Body Composition measured with Total Body Water.

    Percentage of Total Body Water measured by Bioimpedance.

    Measured: 5 months

  15. Body Composition measured with Body Fat.

    Percentage of Body Fat measured by Bioimpedance.

    Measured: 5 months

  16. Blood Pressure (systolic and diastolic)

    Blood Pressure (systolic and diastolic) measured in millimeters of mercury (mmHg)

    Measured: 5 months

  17. Fasting Blood Glucose Levels

    Fasting Blood Glucose Levels measured in mg/dl.

    Measured: 5 months

  18. Fasting Cholesterol Levels

    Fasting Cholesterol Levels measured in mg/dl.

    Measured: 5 months

  19. Daily Physical Activity and Sedentary Behavior measured by the International Physical Activity Questionnaire.

    This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.

    Measured: 5 months

  20. Level of Daytime Sleepiness measured by Epworth Sleepiness Scale (ESS)ESS-EPWORTH.

    The ESS measures a person's general level of daytime sleepiness, or their average sleep propensity in daily life (ASP). The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.

    Measured: 5 months

  21. Intensity of Daily Physical Activity measured by the Accelerometer.

    Measurement of body movement in terms of accelerations.

    Measured: 5 months

  22. Cognition-Processing Speed

    WAIS III test: Digit Symbol-Coding. Measured in number of symbols correctly entered in 2 minutes.

    Measured: 5 months

  23. Cognition-Attention/Vigilance Stroop Test

    Stroop Test: measured in the number of items read or named in 45 seconds for each of the three sheets (word, color, and color-word).

    Measured: 5 months

  24. Cognition-Working Memory Digit Span Backward

    WAIS IV test: Digit Span Backward subtest. Measured with the number of sequences of numbers recalled in inverse order.

    Measured: 5 months

  25. Cognition-Verbal Learning/Memory

    Hopkins Verbal Learning Test-Revised (HVLT-R): number of correct words recalled.

    Measured: 5 months

  26. Cognition-Reasoning/Problem Solving

    Modified Wisconsin Card Sorting Test (M-WCST): score achieved at the M-WCST.

    Measured: 5 months

  27. Cognition-Cognitive Reserve

    Spanish version of the Word Accentuation Test (TAP-E). Measured with the number of correct attempts.

    Measured: 5 months

  28. Cognition-Figural Creativity

    Torrance Test of Creative Thinking: Picture Completion subtest. Measured with Fluency, Originality, Elaboration, Resistance to Premature Closure, Abstractness of Titles, and Creative Strengths dimensions obtained from the drawings made in the task.

    Measured: 5 months

  29. Cognition-Verbal Creativity

    Torrance Test of Creative Thinking: Unusual Uses subtest. Measured with Fluency, Originality, and Flexibility dimensions obtained from the written unusual uses for cardboard boxes and tin cans.

    Measured: 5 months

  30. Social Cognition-Social Attribution

    Social Attribution Test (SAT). SAT is comprised of a 64 second animation with geometric figures enacting a social drama and 19 multiple-choice questions about the animation. Four possible responses are given to each question. Each correct response is scored with 1 point. Total score ranges from 0 to 19.

    Measured: 5 months

  31. Social Cognition-Emotion Recognition

    Bell Lysaker Emotion Recognition Task (BLERT). BLERT consists of 21 short video clips in which an actor displays one of seven emotions with three neutral monologues. The examinee is asked to indicate which emotion the actor is portraying. Each correct response is scored with 1 point. The total score is obtained from the sum of each correct emotion recognition, ranging from 0 to 21.

    Measured: 5 months

  32. Social Cognition-Theory of Mind

    Happe's "Strange Stories Task" Test. Strange Stories Task is comprised of 8 stories concerning double bluff, mistakes, persuasion, and white lies. Each story is scored from 0 to 2. Higher scores indicate a better performance in theory of mind.

    Measured: 5 months

  33. Social Functioning measured by the Social Functioning Scale Short-Form (SFS-15)

    The SFS-15 is a 15-item scale designed to measure social functioning in patients with schizophrenia. It includes items about isolation, interpersonal communication, independence-execution, independence-competence, and employment-occupation. 13 of the items range from 0 to 3 and the other 2 items range from 1 to 2. Total score is obtained from the sum of the 15 items. Total score range from 1 to 43 points. Higher scores indicate higher level of social functioning.

    Measured: 5 months

  34. Self-Efficacy measured by the General Self-Efficacy Scale

    General Self-Efficacy Scale is a 10-item scale that measures optimistic self-beliefs to cope with a variety of difficult demands in life. The scores assigned to each of the item - "Not at all true" (1), "Hardly true" (2), "Moderately true" (3), and "Exactly true" (4) - are summed. The final score ranges from 10 to 40, higher scores indicating a higher level of self-efficacy.

    Measured: 5 months

  35. Social Anhedonia measured with the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)

    The ACIPS is a 17-item scale that consists of 7 anticipatory and 10 consummatory items. The scores assigned to each of the items range from 1 (very false for me) to 6 (very true for me). Total score is obtained from the sum of the 17 items. Higher scores indicate higher ability to experience interpersonal pleasure.

    Measured: 5 months

  36. Handedness measured by the Edinburgh Handedness Inventory

    A self-report questionnaire assessing the dominance of a person's right or left hand in ten different everyday activities.

    Measured: 5 months

  37. Treatment satisfaction measured by the Spanish version of Consumer Reports Effectiveness Scale (CRES-4)

    CRES-4 consists of a 4-item scale designed to evaluate patient's satisfaction with the received therapy. Its global score reflects treatment effectiveness as perceived by the patient. 3 components can be obtained: "satisfaction" (based on the first item, which ranges from 0 to 5), "problem resolution" (based on the second item, which ranges from 0 to 5), and "perceived emotional change" (obtained from the subtraction of the third from the fourth item, which range from 0 to 4). The "satisfaction" component is multiplied by 20, the "problem resolution" by 20 and the "perceived emotional change" by 12.5. Final score is obtained from the sum of the three components, ranging from 0 to 300. Higher scores indicate a greater perception of treatment efficacy.

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2018
  2. Study start1 Mar 2017
  3. Primary completion31 Dec 2019 (estimated)
  4. Study completion1 Jun 2020 (estimated)

Resources

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
Randomized parallel assignment: Cognitive Training, Aerobic Exercise \& Treatment as usual.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03509597
Sponsor's protocol ID
CORTEX-SP Study
Other IDs
PI16/01022
Acronym
CORTEX-SP
Status last verified
Jul 2019
First submitted
11 Apr 2018
Last updated
30 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Sanchez P, Pena J, Bengoetxea E, Ojeda N, Elizagarate E, Ezcurra J, Gutierrez M. Improvements in negative symptoms and functional outcome after a new generation cognitive remediation program: a randomized controlled trial. Schizophr Bull. 2014 May;40(3):707-15. doi: 10.1093/schbul/sbt057. Epub 2013 May 18.

    PubMed 23686130
  • Ojeda N, Pena J, Bengoetxea E, Garcia A, Sanchez P, Elizagarate E, Segarra R, Ezcurra J, Gutierrez-Fraile M, Eguiluz JI. [REHACOP: a cognitive rehabilitation programme in psychosis]. Rev Neurol. 2012 Mar 16;54(6):337-42. Spanish.

    PubMed 22403146
  • Pena J, Ibarretxe-Bilbao N, Sanchez P, Uriarte JJ, Elizagarate E, Gutierrez M, Ojeda N. Mechanisms of functional improvement through cognitive rehabilitation in schizophrenia. J Psychiatr Res. 2018 Jun;101:21-27. doi: 10.1016/j.jpsychires.2018.03.002. Epub 2018 Mar 6.

    PubMed 29525739
  • Pena J, Ibarretxe-Bilbao N, Sanchez P, Iriarte MB, Elizagarate E, Garay MA, Gutierrez M, Iribarren A, Ojeda N. Combining social cognitive treatment, cognitive remediation, and functional skills training in schizophrenia: a randomized controlled trial. NPJ Schizophr. 2016 Nov 9;2:16037. doi: 10.1038/npjschz.2016.37. eCollection 2016.

    PubMed 27868083
  • Ojeda N, Pena J, Bengoetxea E, Garcia A, Sanchez P, Elizagarate E, Segarra R, Ezcurra J, Gutierrez-Fraile M, Eguiluz JI. [Evidence of the effectiveness of cognitive rehabilitation in psychosis and schizophrenia with the REHACOP programme]. Rev Neurol. 2012 May 16;54(10):577-86. Spanish.

    PubMed 22573504
  • Ojeda N, Pena J, Sanchez P, Bengoetxea E, Elizagarate E, Ezcurra J, Gutierrez Fraile M. Efficiency of cognitive rehabilitation with REHACOP in chronic treatment resistant Hispanic patients. NeuroRehabilitation. 2012;30(1):65-74. doi: 10.3233/NRE-2011-0728.

    PubMed 22349843
  • Tous-Espelosin M, Pavon C, Elizagarate E, Sampedro A, Maldonado-Martin S. As We Were and As We Should Be, Combined Exercise Training in Adults With Schizophrenia: CORTEX-SP Study Part II. Scand J Med Sci Sports. 2024 Aug;34(8):e14707. doi: 10.1111/sms.14707.

    PubMed 39054763
  • Tous-Espelosin M, de Azua SR, Iriarte-Yoller N, MartinezAguirre-Betolaza A, Sanchez PM, Corres P, Arratibel-Imaz I, Sampedro A, Pena J, Maldonado-Martin S. Clinical, physical, physiological, and cardiovascular risk patterns of adults with schizophrenia: CORTEX-SP study: Characterization of adults with schizophrenia. Psychiatry Res. 2021 Jan;295:113580. doi: 10.1016/j.psychres.2020.113580. Epub 2020 Nov 18.

    PubMed 33246589

Questions about this trial

What is this clinical trial studying?

A study testing Aerobic Exercise, Cognitive Training and Treatment as usual in people with Schizophrenia, run by Red Salud Mental Araba 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 2 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 30 Jul 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pedro M Sanchez Gomez, MD (+34 945006555 ext. 6558, gomepe@mac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grey Matter Volume Change (time frame: 5 months). The study lists 4 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 NCT03509597, which also lists 8 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 30 Jul 2019; AzTrials last refreshed its copy on 31 Oct 2026.

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