Depression DisorderNCT07253935
Impact of Therapeutic Exercise Integrated With Psychotherapy and Education in Patients With Depression
A study testing Psychotherapy and Graded activity combined with exercise and education in people with Depression Disorder, run by MarcoMateoRiera.
Trial summary
The goal of this clinical trial is to evaluate whether a combined approach including therapeutic exercise, psychotherapy, and therapeutic education can improve depressive symptoms and quality of life in adults diagnosed with depression. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression Disorder
- What is being tested?
- Psychotherapy and Graded activity combined with exercise and education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of depression or dysthymia according to the ICD-11 criteria (including unspecified depressive disorder, code 6A7Z) or DSM-5-TR criteria confirmed by their referring physician.
- A patient currently undergoing psychological treatment for depression with a score above the established cutoff in a validated depression questionnaire.
Who cannot join
- Pregnancy.
- Presence of neurological comorbidities or neurological signs.
- Systemic rheumatic diseases, including fibromyalgia.
- Central nervous system disorders.
- Severe cognitive impairment.
- Schizophrenia, psychotic disorders, or bipolar spectrum disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy of a Combined Approach of Therapeutic Exercise, Psychotherapy, and Therapeutic Education in Patients With Depression: The ACTIDEP Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether a combined approach including therapeutic exercise, psychotherapy, and therapeutic education can improve depressive symptoms and quality of life in adults diagnosed with depression.
The main questions it aims to answer are:
Read more
Does a biobehavioral intervention that integrates exercise, psychotherapy, and education reduce depressive symptoms more effectively than psychotherapy alone? Does this combined approach improve quality of life, physical function, and sleep quality compared with standard psychological therapy? Researchers will compare the intervention group (therapeutic exercise + psychotherapy + education) to the control group (psychotherapy alone) to determine whether the integrated program provides greater improvements in mental health and well-being.
Participants will:
Complete an initial assessment including demographic data, physical tests, and validated questionnaires.
Be randomly assigned to one of the two groups. If in the intervention group, take part in an 8-week telematic program consisting of graded activity, therapeutic exercise, and educational sessions.
Undergo post-intervention assessments and a follow-up evaluation 12 weeks after the program ends.
This study aims to provide evidence on whether combining therapeutic exercise and education with psychotherapy can enhance treatment outcomes and promote long-term adherence to physical activity in people with depression.
Read the detailed description
Depressive disorder is one of the most prevalent and disabling mental health conditions worldwide. Although pharmacological and psychological treatments remain the cornerstone of care, many patients continue to experience residual symptoms, recurrent episodes, or limitations in daily functioning and quality of life. In recent years, exercise-based interventions have gained recognition as a valuable adjunct to conventional treatment, showing beneficial effects on mood regulation, physical health, and overall well-being. Nonetheless, the most effective ways to integrate structured exercise, therapeutic education, and psychotherapy within a coordinated, patient-centered framework are still not well established.
This randomized controlled trial aims to examine the effects of a biobehavioral physiotherapy program that combines graded activity, therapeutic exercise, and patient education delivered concurrently with conventional psychotherapy. The rationale for this combined approach lies in addressing both physical and behavioral components of depression through a structured, progressive, and individualized program. Graded activity is designed to progressively increase patient´s tolerance to physical effort and promote engagement in meaningful daily tasks, while therapeutic education targets maladaptive beliefs about pain, fatigue, and activity avoidance. Together, these components aim to enhance self-efficacy, functional performance, and adherence to recovery-oriented behaviors.
The intervention will be delivered online under professional supervision, ensuring accessibility and continuity of care. The program will last eight weeks and will include structured exercise sessions emphasizing strength, mobility, and aerobic capacity, as well as educational modules focused on pacing, goal setting, and self-management strategies. The use of telehealth enables real-time monitoring, feedback, and personalized adjustments to exercise dosage and progression. Participants in the control group will continue receiving conventional psychotherapy for depression, following their regular clinical routine.
To ensure methodological rigor, randomization will be computer-generated with a 1:1 allocation ratio. Outcome assessments will be conducted by an independent evaluator blinded to group allocation. Standardized and validated measures will be used to assess depressive symptoms, quality of life, physical activity levels, functional capacity, self-efficacy, and sleep quality. Assessments will occur at baseline, mid-intervention, post-intervention, and 12-week follow-up to capture both immediate and sustained effects of the program.
Data will be analyzed following an intention-to-treat approach. Analysis of covariance (ANCOVA) and repeated-measures models will be applied to determine between-group differences and time-by-group interactions, adjusting for baseline scores and potential covariates. Effect sizes will be calculated to estimate the magnitude of the observed effects.
This study is expected to contribute to the growing body of evidence supporting integrative, biobehavioral approaches to the management of depression. By combining exercise and education within a psychotherapeutic framework, the program seeks to promote behavioral activation, enhance perceived control, and improve overall quality of life. If effective, this model could serve as a scalable, cost-effective, and accessible intervention for patients with depressive disorders, expanding the role of physiotherapy and interdisciplinary collaboration in mental health care.
- Conditions
- Depression Disorder
- Being tested
- Psychotherapy, Graded activity combined with exercise and education
- Keywords
- Mental disorders, Depression, Exercise, Physical activity
- Medical subject headings
- Mental Disorders, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychotherapyBehavioural
Also called Acceptance and Commitment Therapy, Behavioral Activation, Cognitive Behavioral Therapy
Conventional psychotherapy for depression, including Acceptance and Commitment Therapy, Behavioral Activation, Cognitive Behavioral Therapy, Interpersonal Therapy, and Mindfulness-Based Cognitive Therapy.
Graded activity combined with exercise and educationBehavioural
Also called Biobehavioral physiotherapy, Therapeutic education, Exercise Therapy
This intervention consists of a graded activity program combined with exercise and therapeutic education in motor behavior to improve physical activity levels, self-efficacy and mood
| Study group | Role | What they receive |
|---|---|---|
| Psychotherapy | Active comparator | Conventional psychotherapy for the treatment of depression. Receives: Behavioral: Psychotherapy |
| Exercise, therapeutic education and psychotherapy | Experimental | Graded activity in combination with exercise, therapeutic education and psychotherapy Receives: Behavioral: Psychotherapy; Behavioral: Graded activity combined with exercise and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depressive symptoms. This is a self-administered questionnaire with nine items scored on a four-point Likert scale (0-3). Higher scores indicate greater severity.
Measured: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment.
Quality of life
The World Health Organization Quality of Life Questionnaire (WHOQoL-BREF) is a self-administered instrument validated in Spanish that assesses perceived quality of life across different domains. It consists of 26 items rated on a 5-point Likert scale, yielding a total score and four domain scores: physical health, psychological health, social relationships, and environment. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life
Measured: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment.
Secondary outcomes (5)
Physical activity levels
The Global Physical Activity Questionnaire (GPAQ) is a self-administered instrument that assesses physical activity across three domains: work-related activity, transportation, and recreational activity. It consists of 16 items that estimate the time spent in different intensities of activity (light, moderate, and vigorous), with results expressed in MET-minutes per week
Measured: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment.
Sleep quality
The Pittsburgh Sleep Quality Index (PSQI) is a valid and reliable instrument (α = 0.76) used to assess sleep quality. It consists of 19 self-reported items evaluating seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each component is scored from 0 to 3, yielding a total score ranging from 0 to 21, with higher scores indicating poorer sleep quality. A global score greater than 5 suggests clinically relevant sleep disturbances.
Measured: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment
Lower limb strength
The 30-Second Chair-Stand Test (30s-CST) is a validated functional test designed to assess lower-limb muscle strength and endurance. It consists of counting the number of times an individual can rise fully from a standard chair without using their arms within a 30-second period. A standard chair (43-45 cm high) is used, with the participant seated upright, feet flat on the floor and arms crossed over the chest.
The outcome is expressed as the total number of correctly completed repetitions within 30 seconds, with higher scores indicating greater lower-limb strength and endurance.
Measured: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment
Maximal oxygen uptake (V̇O2Max)
The Chester Step Test (CST) is a progressive submaximal test used to estimate maximal oxygen uptake (V̇O2Max). It involves stepping up and down on a fixed-height bench (typically 25-30 cm for most adults) following a progressively increasing pace set by a metronome or audio recording.
The test consists of five two-minute stages, with cadence increasing at each stage until the participant reaches 80% of their age-predicted maximum heart rate (220-age) or is unable to maintain the required pace. Throughout the test, heart rate and ratings of perceived exertion (RPE, Borg 6-20 scale) are recorded at the end of each stage.With this information VO2Max values are estimated.
Unit of measure: mlO2/kg/min
Measured: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment
Self-Efficacy to Regulate Exercise
The Self-Efficacy Questionnaire to Regulate Exercise (SEQRE) is a valid and reliable instrument (α = 0.84) consisting of 7 items that assess participants' confidence in maintaining a regular exercise routine (three or more times per week). Each item is rated on a scale from 0 ("I cannot do it at all") to 100 ("I am very confident I can do it"), with higher scores indicating greater perceived self-efficacy for exercise practice
Measured: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Depression DisorderStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MarcoMateoRiera
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07253935
- Sponsor's protocol ID
- ACTIDEP2025RCT
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Diez-Quevedo C, Rangil T, Sanchez-Planell L, Kroenke K, Spitzer RL. Validation and utility of the patient health questionnaire in diagnosing mental disorders in 1003 general hospital Spanish inpatients. Psychosom Med. 2001 Jul-Aug;63(4):679-86. doi: 10.1097/00006842-200107000-00021.
PubMed 11485122Favela Ramírez, C. A., Castro Robles, A. I., Bojórquez Díaz, C. I., & Chan Barocio, N. L. (2022). Propiedades psicométricas del índice de calidad de sueño de Pittsburgh en deportistas. riccafd: Revista Iberoamericana de Ciencias de la Actividad Física y el Deporte, 11(3), 29-46. https://dialnet.unirioja.es/servlet/articulo?codigo=8736227
Lein DH Jr, Alotaibi M, Almutairi M, Singh H. Normative Reference Values and Validity for the 30-Second Chair-Stand Test in Healthy Young Adults. Int J Sports Phys Ther. 2022 Aug 1;17(5):907-914. doi: 10.26603/001c.36432. eCollection 2022.
PubMed 35949374
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Combined Approach of Therapeutic Exercise, Psychotherapy, and Therapeutic Education in Patients With Depression: The ACTIDEP Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07253935
- Acronym / sponsor ID
- ACTIDEP2025RCT
- Conditions
- Depression Disorder
- Keywords
- Mental disorders, Depression, Exercise, Physical activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- MarcoMateoRieraUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 28 Nov 2025 (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 goal of this clinical trial is to evaluate whether a combined approach including therapeutic exercise, psychotherapy, and therapeutic education can improve depressive symptoms and quality of life in adults diagnosed with depression.
The main questions it aims to answer are:
Does a biobehavioral intervention that integrates exercise, psychotherapy, and education reduce depressive symptoms more effectively than psychotherapy alone? Does this combined approach improve quality of life, physical function, and sleep quality compared with standard psychological therapy? Researchers will compare the intervention group (therapeutic exercise + psychotherapy + education) to the control group (psychotherapy alone) to determine whether the integrated program provides greater improvements in mental health and well-being.
Participants will:
Complete an initial assessment including demographic data, physical tests, and validated questionnaires.
Be randomly assigned to one of the two groups. If in the intervention group, take part in an 8-week telematic program consisting of graded activity, therapeutic exercise, and educational sessions.
Undergo post-intervention assessments and a follow-up evaluation 12 weeks after the program ends.
This study aims to provide evidence on whether combining therapeutic exercise and education with psychotherapy can enhance treatment outcomes and promote long-term adherence to physical activity in people with depression.
Detailed description
Depressive disorder is one of the most prevalent and disabling mental health conditions worldwide. Although pharmacological and psychological treatments remain the cornerstone of care, many patients continue to experience residual symptoms, recurrent episodes, or limitations in daily functioning and quality of life. In recent years, exercise-based interventions have gained recognition as a valuable adjunct to conventional treatment, showing beneficial effects on mood regulation, physical health, and overall well-being. Nonetheless, the most effective ways to integrate structured exercise, therapeutic education, and psychotherapy within a coordinated, patient-centered framework are still not well established.
This randomized controlled trial aims to examine the effects of a biobehavioral physiotherapy program that combines graded activity, therapeutic exercise, and patient education delivered concurrently with conventional psychotherapy. The rationale for this combined approach lies in addressing both physical and behavioral components of depression through a structured, progressive, and individualized program. Graded activity is designed to progressively increase patient´s tolerance to physical effort and promote engagement in meaningful daily tasks, while therapeutic education targets maladaptive beliefs about pain, fatigue, and activity avoidance. Together, these components aim to enhance self-efficacy, functional performance, and adherence to recovery-oriented behaviors.
The intervention will be delivered online under professional supervision, ensuring accessibility and continuity of care. The program will last eight weeks and will include structured exercise sessions emphasizing strength, mobility, and aerobic capacity, as well as educational modules focused on pacing, goal setting, and self-management strategies. The use of telehealth enables real-time monitoring, feedback, and personalized adjustments to exercise dosage and progression. Participants in the control group will continue receiving conventional psychotherapy for depression, following their regular clinical routine.
To ensure methodological rigor, randomization will be computer-generated with a 1:1 allocation ratio. Outcome assessments will be conducted by an independent evaluator blinded to group allocation. Standardized and validated measures will be used to assess depressive symptoms, quality of life, physical activity levels, functional capacity, self-efficacy, and sleep quality. Assessments will occur at baseline, mid-intervention, post-intervention, and 12-week follow-up to capture both immediate and sustained effects of the program.
Data will be analyzed following an intention-to-treat approach. Analysis of covariance (ANCOVA) and repeated-measures models will be applied to determine between-group differences and time-by-group interactions, adjusting for baseline scores and potential covariates. Effect sizes will be calculated to estimate the magnitude of the observed effects.
This study is expected to contribute to the growing body of evidence supporting integrative, biobehavioral approaches to the management of depression. By combining exercise and education within a psychotherapeutic framework, the program seeks to promote behavioral activation, enhance perceived control, and improve overall quality of life. If effective, this model could serve as a scalable, cost-effective, and accessible intervention for patients with depressive disorders, expanding the role of physiotherapy and interdisciplinary collaboration in mental health care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychotherapy | Active comparator | Behavioral: PsychotherapyConventional psychotherapy for the treatment of depression. |
| Exercise, therapeutic education and psychotherapy | Experimental | Behavioral: Psychotherapy, Behavioral: Graded activity combined with exercise and educationGraded activity in combination with exercise, therapeutic education and psychotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of depression or dysthymia according to the ICD-11 criteria (including unspecified depressive disorder, code 6A7Z) or DSM-5-TR criteria confirmed by their referring physician.
- A patient currently undergoing psychological treatment for depression with a score above the established cutoff in a validated depression questionnaire.
Key exclusion criteria (6 listed)
- Pregnancy.
- Presence of neurological comorbidities or neurological signs.
- Systemic rheumatic diseases, including fibromyalgia.
- Central nervous system disorders.
- Severe cognitive impairment.
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 |
|---|---|---|
| PsychotherapyAlso: Acceptance and Commitment Therapy, Behavioral Activation, Cognitive Behavioral TherapyConventional psychotherapy for depression, including Acceptance and Commitment Therapy, Behavioral Activation, Cognitive Behavioral Therapy, Interpersonal Therapy, and Mindfulness-Based Cognitive Therapy. | Behavioural | Exercise, therapeutic education and psychotherapy, Psychotherapy |
| Graded activity combined with exercise and educationAlso: Biobehavioral physiotherapy, Therapeutic education, Exercise TherapyThis intervention consists of a graded activity program combined with exercise and therapeutic education in motor behavior to improve physical activity levels, self-efficacy and mood | Behavioural | Exercise, therapeutic education and psychotherapy |
Primary outcome
Depressive symptoms
Time frame: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment.
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess depressive symptoms. This is a self-administered questionnaire with nine items scored on a four-point Likert scale (0-3). Higher scores indicate greater severity.
Quality of life
Time frame: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment.
The World Health Organization Quality of Life Questionnaire (WHOQoL-BREF) is a self-administered instrument validated in Spanish that assesses perceived quality of life across different domains. It consists of 26 items rated on a 5-point Likert scale, yielding a total score and four domain scores: physical health, psychological health, social relationships, and environment. Scores are transformed to a 0-100 scale, with higher scores indicating better quality of life
5 secondary outcomes
Physical activity levels
Time frame: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment.
Sleep quality
Time frame: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment
Lower limb strength
Time frame: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment
Maximal oxygen uptake (V̇O2Max)
Time frame: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment
Self-Efficacy to Regulate Exercise
Time frame: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment
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 28 Nov 2025.
- Background: PubMed 11485122Diez-Quevedo C, Rangil T, Sanchez-Planell L, Kroenke K, Spitzer RL. Validation and utility of the patient health questionnaire in diagnosing mental disorders in 1003 general hospital Spanish inpatients. Psychosom Med. 2001 Jul-Aug;63(4):679-86. doi: 10.1097/00006842-200107000-00021.
- BackgroundFavela Ramírez, C. A., Castro Robles, A. I., Bojórquez Díaz, C. I., & Chan Barocio, N. L. (2022). Propiedades psicométricas del índice de calidad de sueño de Pittsburgh en deportistas. riccafd: Revista Iberoamericana de Ciencias de la Actividad Física y el Deporte, 11(3), 29-46. https://dialnet.unirioja.es/servlet/articulo?codigo=8736227
- Background: PubMed 35949374Lein DH Jr, Alotaibi M, Almutairi M, Singh H. Normative Reference Values and Validity for the 30-Second Chair-Stand Test in Healthy Young Adults. Int J Sports Phys Ther. 2022 Aug 1;17(5):907-914. doi: 10.26603/001c.36432. eCollection 2022.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapy and Graded activity combined with exercise and education in people with Depression Disorder, run by MarcoMateoRiera.
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 2 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: opening soon, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Roy La Touche, PhD (+34 917401980, roylatouche@lasallecampus.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: From enrollment to the end of treatment at 8 weeks, with follow-up 12 weeks after completion of treatment.). The study lists 2 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 NCT07253935, which also lists 3 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 28 Nov 2025.