Depressive Disorder, MajorNCT02076425
A Randomized Controlled Trial of PCIT-ED for Preschool Depression
A study testing PCIT-ED in people with Depressive Disorder, Major, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a sample of preschoolers who exhibit symptoms of depression compared to a wait list (WL) control after which participants will receive the active treatment. Read more about this study
- Who is it for?
- Ages 36 to 83 months
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- PCIT-ED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2014to 10 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 36 to 83 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who meet all DSM-IV MDD symptom criteria (adjusted for development)
Who cannot join
- Children with serious chronic medical illness
- Children with Autistic Spectrum Disorders (based on clinical diagnosis or Social Responsiveness Scale scores which will be administered when there is suspicion of an ASD)
- Children with significant speech delays
- Children with general developmental delays or IQ < 70
- Children with chronic neurological problems/illnesses
- Children adopted after 12 months of age
Show all 11Show fewer
- Children on antidepressants
- Children taking unstable doses of other psychotropic medications without antidepressant properties
- Children participating in ongoing psychotherapy
- Children in unstable placements (not with same caregiver for 6 months prior to study enrollment)
- Children who are too ill to wait 18 weeks for treatment (e.g. having active suicidal ideation and/or in acute/serious distress)
Trial locations and contacts
1 site in 1 country.
United States1 site
Early Emotional Development Program
St Louis, Missouri, 63108
About this study
Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a sample of preschoolers who exhibit symptoms of depression compared to a wait list (WL) control after which participants will receive the active treatment. PCIT-ED is an expansion of PCIT, a well-known, widely used and proven effective treatment for preschool disruptive disorders. To address early disturbances of mood and affect, a novel ED module was added based on empirical data in emotion development. The ED module targets parent emotion learning skills with the goal of training the parent to serve as a more effective emotion teacher and coach to the child. The goal of the ED module is to enhance the child's capacity for emotion recognition and regulation or "emotional competence." In order to test the efficacy of PCIT-ED, to estimate accurate effect sizes and to investigate mediators and moderators of treatment response participants will complete comprehensive pre-, interval, and post-assessments.
Preschoolers over 3 will be offered the option of enrolling in an add-on electroencephalography and magnetic resonance imagery study, to investigate neural changes associated with PCIT-ED.
Compared to those randomized to the WL, preschoolers who undergo PCIT-ED will show significantly increased rates of remission, greater reductions in MDD symptoms, and decreases in impairment; and will show significantly greater increases in emotional competence measured by the ability to accurately identify emotions in themselves and others and the ability to effectively regulate intense emotions. Compared to those on the WL, parents who undergo PCIT-ED will show significantly greater increases in emotion skill learning and reductions in MDD symptoms and parenting stress.
- Conditions
- Depressive Disorder, Major
- Being tested
- PCIT-ED
- Keywords
- Depressive Disorder, Major, Child Psychiatry, Parent-Child Relationship, Therapy
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIT-EDBehavioural
| Study group | Role | What they receive |
|---|---|---|
| PCIT-ED | Experimental | Parent-Child Interaction Therapy - Emotional Development (PCIT-ED) is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. Receives: Behavioral: PCIT-ED |
| Wait List | No intervention | No intervention while subjects wait for PCIT-ED in the second phase of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (KSADS-EC) MDD Core Symptom Score
The Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (K-SADS-EC) is a semi-structured clinical interview for DSM-5 disorders adapted for use in children aged 3-6. The MDD core symptom score was the number of core MDD symptoms endorsed on the K-SADS-EC. These 9 symptoms were (1) depressed mood, (2) anhedonia, (3) insomnia/hypersomnia, (4) fatigue, (5) decreased concentration, (6) weight/appetite change, (7) psychomotor agitation/retardation, (8) worthlessness/guilt, (9) suicidal thoughts/behaviors. The range of possible values is 0-9, with 9 being the worst outcome.
Measured: completion of therapy (average of 20 weeks)
Secondary outcomes (1)
Preschool Feelings Checklist-Scale Version (PFC-Scale) Score
The Preschool Feelings Checklist - Scale Version (PFC-Scale), was adapted from the PFC, which is a validated screening checklist used to capture young children at high risk for MDD. The PFC-Scale is a 23-item Likert scale with possible values of 0, 1, 2, 3, or 4 for each item. The total score is a sum of the 23 items, so the range of possible values is 0-92, with 92 being the most severe score possible.
Measured: completion of therapy (average of 20 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study start13 Jan 2014
- Primary completion31 Mar 2018
- Study completion10 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joan L Luby, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076425
- Sponsor's protocol ID
- R01MH098454-02
- Status last verified
- Nov 2019
- First submitted
- 25 Feb 2014
- Last updated
- 2 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Luby J, Lenze S, Tillman R. A novel early intervention for preschool depression: findings from a pilot randomized controlled trial. J Child Psychol Psychiatry. 2012 Mar;53(3):313-22. doi: 10.1111/j.1469-7610.2011.02483.x. Epub 2011 Oct 31.
PubMed 22040016Luby JL, Barch DM, Whalen D, Tillman R, Freedland KE. A Randomized Controlled Trial of Parent-Child Psychotherapy Targeting Emotion Development for Early Childhood Depression. Am J Psychiatry. 2018 Nov 1;175(11):1102-1110. doi: 10.1176/appi.ajp.2018.18030321. Epub 2018 Jun 20.
PubMed 29921144Luby JL, Gilbert K, Whalen D, Tillman R, Barch DM. The Differential Contribution of the Components of Parent-Child Interaction Therapy Emotion Development for Treatment of Preschool Depression. J Am Acad Child Adolesc Psychiatry. 2020 Jul;59(7):868-879. doi: 10.1016/j.jaac.2019.07.937. Epub 2019 Jul 31.
PubMed 31376501Barch DM, Whalen D, Gilbert K, Kelly D, Kappenman ES, Hajcak G, Luby JL. Neural Indicators of Anhedonia: Predictors and Mechanisms of Treatment Change in a Randomized Clinical Trial in Early Childhood Depression. Biol Psychiatry. 2019 May 15;85(10):863-871. doi: 10.1016/j.biopsych.2018.11.021. Epub 2018 Dec 4.
PubMed 30583852Barch DM, Hennefield L, Thompson RJ, Hoyniak CP, Tillman R, Luking K, Redic MM, Gilbert K, Donohue MR, Whalen D, Luby JL. Reactivity to Interpersonal Conflict: A Correlate of Non-Remission in Childhood Depression-Evidence Across Modalities and Time Scales. Depress Anxiety. 2026 Jul 28;2026:5803578. doi: 10.1155/da/5803578. eCollection 2026.
PubMed 42524169Elansary M, Barch DM, Tillman R, Dandrea CB, Vogel AC, Donohue MR, Hennefield L, Gilbert K, Luby JL. Preadolescent Benefits of Parent-Child Interaction Therapy Emotion Development for Preschool Depression: 4-Year Follow-Up. J Am Acad Child Adolesc Psychiatry. 2026 May;65(5):669-684. doi: 10.1016/j.jaac.2025.06.011. Epub 2025 Jun 27.
PubMed 40582466Schwartz KTG, Chronis-Tuscano A, Tillman R, Whalen D, Gilbert KE, Luby J. Parent-child psychotherapy targeting emotion development: unpacking the impact of parental depression on child, parenting and engagement outcomes. Eur Child Adolesc Psychiatry. 2023 Dec;32(12):2491-2501. doi: 10.1007/s00787-022-02093-5. Epub 2022 Oct 10.
PubMed 36216984Donohue MR, Hoyniak CP, Tillman R, Barch DM, Luby J. Callous-Unemotional Traits as an Intervention Target and Moderator of Parent-Child Interaction Therapy-Emotion Development Treatment for Preschool Depression and Conduct Problems. J Am Acad Child Adolesc Psychiatry. 2021 Nov;60(11):1394-1403. doi: 10.1016/j.jaac.2021.03.018. Epub 2021 May 20.
PubMed 33865929Barch DM, Whalen D, Gilbert K, Kelly D, Kappenman ES, Hajcak G, Luby JL. Neural Indicators of Anhedonia: Predictors and Mechanisms of Treatment Change in a Randomized Clinical Trial in Early Childhood Depression. Biol Psychiatry. 2020 Dec 1;88(11):879-887. doi: 10.1016/j.biopsych.2020.06.032.
PubMed 33153527Hoyniak CP, Whalen DJ, Barch D, Luby JL. Sleep problems in preschool-onset major depressive disorder: the effect of treatment with parent-child interaction therapy-emotion development. Eur Child Adolesc Psychiatry. 2021 Sep;30(9):1463-1474. doi: 10.1007/s00787-020-01641-1. Epub 2020 Sep 15.
PubMed 32935261Whalen DJ, Gilbert KE, Luby JL. Changes in self-reported and observed parenting following a randomized control trial of parent-child interaction therapy for the treatment of preschool depression. J Child Psychol Psychiatry. 2021 Jan;62(1):86-96. doi: 10.1111/jcpp.13263. Epub 2020 May 29.
PubMed 32469454Whalen DJ, Gilbert KE, Kelly D, Hajcak G, Kappenman ES, Luby JL, Barch DM. Preschool-Onset Major Depressive Disorder is Characterized by Electrocortical Deficits in Processing Pleasant Emotional Pictures. J Abnorm Child Psychol. 2020 Jan;48(1):91-108. doi: 10.1007/s10802-019-00585-8.
PubMed 31515716Gilbert K, Barch DM, Luby JL. The Overcontrol in Youth Checklist (OCYC): Behavioral and Neural Validation of a Parent-Report of Child Overcontrol in Early Childhood. Child Psychiatry Hum Dev. 2020 Feb;51(1):27-38. doi: 10.1007/s10578-019-00907-3.
PubMed 31256293Luby JL, Whalen D, Tillman R, Barch DM. Clinical and Psychosocial Characteristics of Young Children With Suicidal Ideation, Behaviors, and Nonsuicidal Self-Injurious Behaviors. J Am Acad Child Adolesc Psychiatry. 2019 Jan;58(1):117-127. doi: 10.1016/j.jaac.2018.06.031. Epub 2018 Oct 22.
PubMed 30577927Belden AC, Irvin K, Hajcak G, Kappenman ES, Kelly D, Karlow S, Luby JL, Barch DM. Neural Correlates of Reward Processing in Depressed and Healthy Preschool-Age Children. J Am Acad Child Adolesc Psychiatry. 2016 Dec;55(12):1081-1089. doi: 10.1016/j.jaac.2016.09.503. Epub 2016 Oct 4.
PubMed 27871643
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of PCIT-ED for Preschool Depression
- ClinicalTrials.gov ID
- NCT02076425
- Acronym / sponsor ID
- R01MH098454-02
- Conditions
- Depressive Disorder, Major
- Keywords
- Depressive Disorder, Major, Child Psychiatry, Parent-Child Relationship, Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 13 Jan 2014 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 10 May 2018 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Posted 2 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a sample of preschoolers who exhibit symptoms of depression compared to a wait list (WL) control after which participants will receive the active treatment. PCIT-ED is an expansion of PCIT, a well-known, widely used and proven effective treatment for preschool disruptive disorders. To address early disturbances of mood and affect, a novel ED module was added based on empirical data in emotion development. The ED module targets parent emotion learning skills with the goal of training the parent to serve as a more effective emotion teacher and coach to the child. The goal of the ED module is to enhance the child's capacity for emotion recognition and regulation or "emotional competence." In order to test the efficacy of PCIT-ED, to estimate accurate effect sizes and to investigate mediators and moderators of treatment response participants will complete comprehensive pre-, interval, and post-assessments.
Preschoolers over 3 will be offered the option of enrolling in an add-on electroencephalography and magnetic resonance imagery study, to investigate neural changes associated with PCIT-ED.
Compared to those randomized to the WL, preschoolers who undergo PCIT-ED will show significantly increased rates of remission, greater reductions in MDD symptoms, and decreases in impairment; and will show significantly greater increases in emotional competence measured by the ability to accurately identify emotions in themselves and others and the ability to effectively regulate intense emotions. Compared to those on the WL, parents who undergo PCIT-ED will show significantly greater increases in emotion skill learning and reductions in MDD symptoms and parenting stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCIT-ED | Experimental | Behavioral: PCIT-EDParent-Child Interaction Therapy - Emotional Development (PCIT-ED) is a promising early intervention for depression that directly targets developing affective systems and builds on the empirical literature on emotion development and prevention. |
| Wait List | No intervention | –No intervention while subjects wait for PCIT-ED in the second phase of the study. |
Who may qualify
- Ages
- 36 to 83 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children who meet all DSM-IV MDD symptom criteria (adjusted for development)
Key exclusion criteria (11 listed)
- Children with serious chronic medical illness
- Children with Autistic Spectrum Disorders (based on clinical diagnosis or Social Responsiveness Scale scores which will be administered when there is suspicion of an ASD)
- Children with significant speech delays
- Children with general developmental delays or IQ < 70
- Children with chronic neurological problems/illnesses
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 |
|---|---|---|
| PCIT-ED | Behavioural | PCIT-ED |
Primary outcome
Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (KSADS-EC) MDD Core Symptom Score
Time frame: completion of therapy (average of 20 weeks)
The Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (K-SADS-EC) is a semi-structured clinical interview for DSM-5 disorders adapted for use in children aged 3-6. The MDD core symptom score was the number of core MDD symptoms endorsed on the K-SADS-EC. These 9 symptoms were (1) depressed mood, (2) anhedonia, (3) insomnia/hypersomnia, (4) fatigue, (5) decreased concentration, (6) weight/appetite change, (7) psychomotor agitation/retardation, (8) worthlessness/guilt, (9) suicidal thoughts/behaviors. The range of possible values is 0-9, with 9 being the worst outcome.
1 secondary outcome
Preschool Feelings Checklist-Scale Version (PFC-Scale) Score
Time frame: completion of therapy (average of 20 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22040016Luby J, Lenze S, Tillman R. A novel early intervention for preschool depression: findings from a pilot randomized controlled trial. J Child Psychol Psychiatry. 2012 Mar;53(3):313-22. doi: 10.1111/j.1469-7610.2011.02483.x. Epub 2011 Oct 31.
- Results publication: PubMed 29921144Luby JL, Barch DM, Whalen D, Tillman R, Freedland KE. A Randomized Controlled Trial of Parent-Child Psychotherapy Targeting Emotion Development for Early Childhood Depression. Am J Psychiatry. 2018 Nov 1;175(11):1102-1110. doi: 10.1176/appi.ajp.2018.18030321. Epub 2018 Jun 20.
- Results publication: PubMed 31376501Luby JL, Gilbert K, Whalen D, Tillman R, Barch DM. The Differential Contribution of the Components of Parent-Child Interaction Therapy Emotion Development for Treatment of Preschool Depression. J Am Acad Child Adolesc Psychiatry. 2020 Jul;59(7):868-879. doi: 10.1016/j.jaac.2019.07.937. Epub 2019 Jul 31.
- Results publication: PubMed 30583852Barch DM, Whalen D, Gilbert K, Kelly D, Kappenman ES, Hajcak G, Luby JL. Neural Indicators of Anhedonia: Predictors and Mechanisms of Treatment Change in a Randomized Clinical Trial in Early Childhood Depression. Biol Psychiatry. 2019 May 15;85(10):863-871. doi: 10.1016/j.biopsych.2018.11.021. Epub 2018 Dec 4.
- Derived from this study: PubMed 42524169Barch DM, Hennefield L, Thompson RJ, Hoyniak CP, Tillman R, Luking K, Redic MM, Gilbert K, Donohue MR, Whalen D, Luby JL. Reactivity to Interpersonal Conflict: A Correlate of Non-Remission in Childhood Depression-Evidence Across Modalities and Time Scales. Depress Anxiety. 2026 Jul 28;2026:5803578. doi: 10.1155/da/5803578. eCollection 2026.
- Derived from this study: PubMed 40582466Elansary M, Barch DM, Tillman R, Dandrea CB, Vogel AC, Donohue MR, Hennefield L, Gilbert K, Luby JL. Preadolescent Benefits of Parent-Child Interaction Therapy Emotion Development for Preschool Depression: 4-Year Follow-Up. J Am Acad Child Adolesc Psychiatry. 2026 May;65(5):669-684. doi: 10.1016/j.jaac.2025.06.011. Epub 2025 Jun 27.
- Derived from this study: PubMed 36216984Schwartz KTG, Chronis-Tuscano A, Tillman R, Whalen D, Gilbert KE, Luby J. Parent-child psychotherapy targeting emotion development: unpacking the impact of parental depression on child, parenting and engagement outcomes. Eur Child Adolesc Psychiatry. 2023 Dec;32(12):2491-2501. doi: 10.1007/s00787-022-02093-5. Epub 2022 Oct 10.
- Derived from this study: PubMed 33865929Donohue MR, Hoyniak CP, Tillman R, Barch DM, Luby J. Callous-Unemotional Traits as an Intervention Target and Moderator of Parent-Child Interaction Therapy-Emotion Development Treatment for Preschool Depression and Conduct Problems. J Am Acad Child Adolesc Psychiatry. 2021 Nov;60(11):1394-1403. doi: 10.1016/j.jaac.2021.03.018. Epub 2021 May 20.
- Derived from this study: PubMed 33153527Barch DM, Whalen D, Gilbert K, Kelly D, Kappenman ES, Hajcak G, Luby JL. Neural Indicators of Anhedonia: Predictors and Mechanisms of Treatment Change in a Randomized Clinical Trial in Early Childhood Depression. Biol Psychiatry. 2020 Dec 1;88(11):879-887. doi: 10.1016/j.biopsych.2020.06.032.
- Derived from this study: PubMed 32935261Hoyniak CP, Whalen DJ, Barch D, Luby JL. Sleep problems in preschool-onset major depressive disorder: the effect of treatment with parent-child interaction therapy-emotion development. Eur Child Adolesc Psychiatry. 2021 Sep;30(9):1463-1474. doi: 10.1007/s00787-020-01641-1. Epub 2020 Sep 15.
- Derived from this study: PubMed 32469454Whalen DJ, Gilbert KE, Luby JL. Changes in self-reported and observed parenting following a randomized control trial of parent-child interaction therapy for the treatment of preschool depression. J Child Psychol Psychiatry. 2021 Jan;62(1):86-96. doi: 10.1111/jcpp.13263. Epub 2020 May 29.
- Derived from this study: PubMed 31515716Whalen DJ, Gilbert KE, Kelly D, Hajcak G, Kappenman ES, Luby JL, Barch DM. Preschool-Onset Major Depressive Disorder is Characterized by Electrocortical Deficits in Processing Pleasant Emotional Pictures. J Abnorm Child Psychol. 2020 Jan;48(1):91-108. doi: 10.1007/s10802-019-00585-8.
- Early Emotional Development Program WebsiteLink provided by the sponsor.
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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.
Joan L Luby, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCIT-ED in people with Depressive Disorder, Major, run by Washington University School of Medicine at 1 site in United States.
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 1 inclusion and 11 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 2 Dec 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 United States. 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?
Yes. Results are posted in the registry (first posted 2 Dec 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Kiddie Schedule for Affective Disorders and Schizophrenia - Early Childhood (KSADS-EC) MDD Core Symptom Score (time frame: completion of therapy (average of 20 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 NCT02076425, which also lists 15 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 2 Dec 2019.