Mild to Moderate Psychopathological SymptomsNCT05051462
Efficacy of Family Constellations in the General Population
A study testing Family / systemic constellation therapy in people with Mild to Moderate Psychopathological Symptoms, run by Károli Gáspár University of the Reformed Church in Hungary at 1 site in Hungary.
Trial summary
The purpose of this study is to investigate the efficacy of systemic / family constellation therapy in improving mild-moderate psychopathological symptoms and overall wellbeing in the general population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild to Moderate Psychopathological Symptoms
- What is being tested?
- Family / systemic constellation therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteHungary
- Study dates
- 19 Jul 2021to 25 Apr 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to participate in the in-person intervention on the date randomly assigned to them
Who cannot join
- Participation in family / systemic constellation therapy within the 12 months prior to study launch
- Current mental disorder diagnosed by an eligible health care professional
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Károli Gáspár University of the Reformed Church in Hungary
Budapest
About this study
Official title: Efficacy of Family / Systemic Constellation Therapy in the General Population. A Randomized Wait-list Controlled Trial
The purpose of this study is to investigate the efficacy of systemic / family constellation therapy in improving mild-moderate psychopathological symptoms and overall wellbeing in the general population. Given the limited amount of evidence on this therapeutic method, special attention will be given to monitor potential adverse outcomes to establish intervention safety. The study will use a randomized, wait-list controlled design and a 6-month follow-up time. This is the second study of this nature following a similar study from Germany.
Read the detailed description
Family/systemic constellation therapy is a system-oriented, short-term group counseling intervention aiming to help clients better understand and resolve their conflicts within their intra- or interpersonal systems, which in turn might lead to a decrease in psychopathological and functional somatic symptoms as well as improvement in overall quality of life. This intervention modality was developed in Germany in the early 1990s integrating elements of - among others - psychodrama, family sculptures, contextual therapy, and certain South-African aboriginal traditions.
Compared to its widespread use by therapists of various theoretical and professional backgrounds all over the world, little effort has been made to generate empirical data regarding the efficacy and safety of this intervention and the overall quality and quantity of the extant evidence is low. Authors of the only (although high-quality) previous randomized controlled trial to date into the efficacy of systemic constellations reported that the intervention was efficacious in reducing general, non-diagnosis-specific psychopathology and psychological distress both in the short- as well as middle- and long term. A recent systematic review summarizing both the peer-reviewed and the grey literature on the mental health effects of systemic constellation therapy concluded that further studies into its efficacy and effectiveness are greatly needed, especially if employing 1) a controlled, ideally randomized-controlled design, 2) at least mid-term follow-up (≥6 months) to evaluate client outcomes and 3) active monitoring of potential iatrogenic effects.
In line with these recommendations, the aim of the present study - when designed - was to collect and analyze further data on the efficacy of systemic constellation therapy in its traditional format in improving mental health. However, the COVID pandemic required the intervention providers to make substantial changes to the usual treatment protocol; therefore, the study in its final form rather serves the purpose of investigating the efficacy of a pandemic-adjusted version of family/systemic constellation workshops than that of the intervention in general.
- Being tested
- Family / systemic constellation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family / systemic constellation therapyBehavioural
Family / systemic constellation therapy is a short-term group counseling intervention aiming to help clients better understand and resolve their conflicts within their personal systems, which in turn might lead to a decrease in psychopathological or functional somatic symptoms. The personal system addressed is most often the family but other inter- or intrapersonal systems (e.g., ego parts, victim-perpetrator dyads) can also be the target of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Study participants participating in family constellation therapy between assessment 1 and 2. Receives: Behavioral: Family / systemic constellation therapy |
| Wait-list control group | No intervention | Study participants participating in family constellation therapy only after all 3 assessment points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Brief Symptom Inventory Scores
The Brief Symptom Inventory is a a broad-spectrum measure of psychopathology covering 9 symptom dimensions: Somatization, Obsessive-compulsive symptoms, Interpersonal sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation, and Psychoticism. The BSI includes a global index of distress (the General Severity Index, GSI) that reflects the mean of all items, which is used here. The GSI ranges between 0 to 4, higher scores indicative of a higher degree of symptom severity.
Measured: 1 month post-intervention
Change in Brief Symptom Inventory Scores
The Brief Symptom Inventory is a a broad-spectrum measure of psychopathology covering 9 symptom dimensions: Somatization, Obsessive-compulsive symptoms, Interpersonal sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation, and Psychoticism. The BSI also includes a global index of distress (the General Severity Index, GSI) that reflects the mean of all items, which is used here. The GSI ranges between 0 to 4, higher scores indicative of a higher degree of symptom severity.
Measured: 6 month post-intervention
Secondary outcomes (14)
Change in Eating Disorder Risk Assessed by the SCOFF Screening Test
The SCOFF consists of five yes-or-no type questions assessing eating disorder symptoms or risk factors. Higher scores (ranging between 0 and 5) are indicative of greater risk. At least two positive answers (score of 2) indicate a high likelihood of an eating disorder.
Measured: 1 month post-intervention
Change in Eating Disorder Risk Assessed by the SCOFF Screening Test
The SCOFF consists of five yes-or-no type questions assessing eating disorder symptoms or risk factors. Higher scores (ranging between 0 and 5) are indicative of greater risk. At least two positive answers (score of 2) indicate a high likelihood of an eating disorder.
Measured: 6 month post-intervention
Change in Substance- and Behavioral Addiction Severity Assessed by the SSBA-G
The SSBA-G (Generalised version of the Screener for Substance and Behavioural Addictions) is comprised of 8 items (4 items assessing substance-related and 4 assessing behavioral addictions). Items reflect a distinct sign or symptom of potentially problematic involvement into an addictive behavior ("I did it too much;" "Once I started, I couldn't stop;" "I felt I had to do it in order to function;" and "I continued to do it, even though it caused problems"). Scores range between 8 and 56 with higher scores indicative of higher problem severity.
Measured: 1 month post-intervention
Change in Substance- and Behavioral Addiction Severity Assessed by the SSBA-G
The SSBA-G (Generalised version of the Screener for Substance and Behavioural Addictions) is comprised of 8 items (4 items assessing substance-related and 4 assessing behavioral addictions). Items reflect a distinct sign or symptom of potentially problematic involvement into an addictive behavior ("I did it too much;" "Once I started, I couldn't stop;" "I felt I had to do it in order to function;" and "I continued to do it, even though it caused problems"). Scores range between 8 and 56 with higher scores indicative of higher problem severity.
Measured: 6 month post-intervention
Change in Quality of Life Specific to Interpersonal Relationships Using the Experience in Personal Social Systems Questionnaire (EXIS.Pers)
The EXIS.pers assesses the subjective experiences of the individual in their personal social system (e.g. family, circle of friends) covering four dimensions in relation to belonging, autonomy, accord, and confidence. Scores range between 12 and 72 with higher scores are indicative of better functioning.
Measured: 1 month post-intervention
Change in Quality of Life Specific to Interpersonal Relationships Using the Experience in Personal Social Systems Questionnaire (EXIS.Pers)
The EXIS.pers assesses the subjective experiences of the individual in their personal social system (e.g. family, circle of friends) covering four dimensions in relation to belonging, autonomy, accord, and confidence. Scores range between 12 and 72 with higher scores are indicative of better functioning.
Measured: 6 month post-intervention
Change in Perceived Level of Meaning in Life Using the Meaning in Life Questionnaire (MLQ)
The Presence of Meaning Subscale of the MLQ assesses perceived level of meaningfulness in a respondent's life. The subscale consists of 5 items, and the total scores range between 5 and 35. Higher scores are indicative of better functioning and quality of life.
Measured: 1 month post-intervention
Change in Perceived Level of Meaning in Life Using the Meaning in Life Questionnaire (MLQ)
The Presence of Meaning Subscale of the MLQ assesses perceived level of meaningfulness in a respondent's life. The subscale consists of 5 items, and the total scores range between 5 and 35. Higher scores are indicative of better functioning and quality of life.
Measured: 6 month post-intervention
Change in Life Satisfaction Using the Satisfaction With Life Scale (SWLS)
The SWLS is a measure of general satisfaction with one's life. Scores range from 5 to 35 with higher scores indicative of higher life satisfaction.
Measured: 1 month post-intervention
Change in Life Satisfaction Using the Satisfaction With Life Scale (SWLS)
The SWLS is a measure of general satisfaction with one's life. Scores range from 5 to 35 with higher scores indicative of higher life satisfaction.
Measured: 6 month post-intervention
Change in General Well-being Using the 5-item Version of the WHO Wellbeing Index (WBI-5)
The WBI-5 measures participants' overall subjective well-being. Scores range between 0 and 15 with higher scores indicative of greater well-being.
Measured: 1 month post-intervention
Change in General Well-being Using the 5-item Version of the WHO Wellbeing Index (WBI-5)
The WBI-5 measures participants' overall subjective well-being. Scores range between 0 and 15 with higher scores indicative of greater well-being.
Measured: 6 month post-intervention
Perceived Negative Effects of the Intervention Using ad Hoc Questions
Two questions were asked from respondents:
- "On the constellation seminar you participated in one month ago or since then, have you experienced any unfavorable change in your family life, your relationships with others or your interpersonal style in general that you attribute to the constellation seminar or can imagine that it is related to your participation in it?"
- "On the constellation seminar you participated in one month ago or since then, have you experienced any unfavorable mental or physical change in your personal life that you attribute to the constellation seminar or can imagine that it is related to your participation in it?" The number of participants who answered affirmatively to one or both questions above are reported here. Please note that the wording above is a hypersensitive approach to gather data on iatrogenic effects (cf. "can imagine that it is related to your participation").
Measured: 1 month post-intervention
Perceived Negative Effects of the Intervention Using ad Hoc Questions
Two questions were asked from respondents:
- "In the past 5 months (since the completion of the first follow-up questionnaire of this study), have you experienced any unfavorable change in your family life, your relationships with others or your interpersonal style in general that you attribute to the constellation seminar or can imagine that it is related to your participation in it?"
- "In the past 5 months (since the completion of the first follow-up questionnaire of this study), have you experienced any unfavorable mental or physical change in your personal life that you attribute to the constellation seminar or can imagine that it is related to your participation in it?" The number of participants who answered affirmatively to one or both questions above are reported here. Please note that the wording above is a hypersensitive approach to gather data on iatrogenic effects (cf. "can imagine that it is related to your participation").
Measured: 6 month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start19 Jul 2021
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
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 (3)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate Psychopathological SymptomsStudies 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Károli Gáspár University of the Reformed Church in Hungary
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
- Investigators
- Barna Konkoly-Thege, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051462
- Sponsor's protocol ID
- BTK/591-1/2021
- Status last verified
- Sep 2025
- First submitted
- 9 Jul 2021
- Last updated
- 26 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The authors are concerned that making individual participant data available to others would seriously jeopardize participants' willingness to participate in the study. Therefore, the authors offer that they will conduct any alternative analyses on the data set other researchers are interested in and the authors will share the raw output of those analyses including the analytical syntaxes.
Publications
Konkoly Thege B, Petroll C, Rivas C, Scholtens S. The Effectiveness of Family Constellation Therapy in Improving Mental Health: A Systematic Review. Fam Process. 2021 Jun;60(2):409-423. doi: 10.1111/famp.12636. Epub 2021 Feb 2.
PubMed 33528854Weinhold J, Hunger C, Bornhauser A, Link L, Rochon J, Wild B, Schweitzer J. Family constellation seminars improve psychological functioning in a general population sample: results of a randomized controlled trial. J Couns Psychol. 2013 Oct;60(4):601-9. doi: 10.1037/a0033539. Epub 2013 Aug 19.
PubMed 23957767Konkoly Thege B, Szabo GS. The efficacy of pandemic-adjusted family/systemic constellation therapy in improving psychopathological symptoms: A randomized controlled trial. J Psychiatr Res. 2024 Sep;177:271-278. doi: 10.1016/j.jpsychires.2024.07.027. Epub 2024 Jul 18.
PubMed 39053295
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Family / Systemic Constellation Therapy in the General Population. A Randomized Wait-list Controlled Trial
- ClinicalTrials.gov ID
- NCT05051462
- Acronym / sponsor ID
- BTK/591-1/2021
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Károli Gáspár University of the Reformed Church in HungaryUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Posted 26 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the efficacy of systemic / family constellation therapy in improving mild-moderate psychopathological symptoms and overall wellbeing in the general population. Given the limited amount of evidence on this therapeutic method, special attention will be given to monitor potential adverse outcomes to establish intervention safety. The study will use a randomized, wait-list controlled design and a 6-month follow-up time. This is the second study of this nature following a similar study from Germany.
Detailed description
Family/systemic constellation therapy is a system-oriented, short-term group counseling intervention aiming to help clients better understand and resolve their conflicts within their intra- or interpersonal systems, which in turn might lead to a decrease in psychopathological and functional somatic symptoms as well as improvement in overall quality of life. This intervention modality was developed in Germany in the early 1990s integrating elements of - among others - psychodrama, family sculptures, contextual therapy, and certain South-African aboriginal traditions.
Compared to its widespread use by therapists of various theoretical and professional backgrounds all over the world, little effort has been made to generate empirical data regarding the efficacy and safety of this intervention and the overall quality and quantity of the extant evidence is low. Authors of the only (although high-quality) previous randomized controlled trial to date into the efficacy of systemic constellations reported that the intervention was efficacious in reducing general, non-diagnosis-specific psychopathology and psychological distress both in the short- as well as middle- and long term. A recent systematic review summarizing both the peer-reviewed and the grey literature on the mental health effects of systemic constellation therapy concluded that further studies into its efficacy and effectiveness are greatly needed, especially if employing 1) a controlled, ideally randomized-controlled design, 2) at least mid-term follow-up (≥6 months) to evaluate client outcomes and 3) active monitoring of potential iatrogenic effects.
In line with these recommendations, the aim of the present study - when designed - was to collect and analyze further data on the efficacy of systemic constellation therapy in its traditional format in improving mental health. However, the COVID pandemic required the intervention providers to make substantial changes to the usual treatment protocol; therefore, the study in its final form rather serves the purpose of investigating the efficacy of a pandemic-adjusted version of family/systemic constellation workshops than that of the intervention in general.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Family / systemic constellation therapyStudy participants participating in family constellation therapy between assessment 1 and 2. |
| Wait-list control group | No intervention | –Study participants participating in family constellation therapy only after all 3 assessment points. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ability to participate in the in-person intervention on the date randomly assigned to them
Key exclusion criteria (2 listed)
- Participation in family / systemic constellation therapy within the 12 months prior to study launch
- Current mental disorder diagnosed by an eligible health care professional
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 |
|---|---|---|
| Family / systemic constellation therapyFamily / systemic constellation therapy is a short-term group counseling intervention aiming to help clients better understand and resolve their conflicts within their personal systems, which in turn might lead to a decrease in psychopathological or functional somatic symptoms. The personal system addressed is most often the family but other inter- or intrapersonal systems (e.g., ego parts, victim-perpetrator dyads) can also be the target of the intervention. | Behavioural | Intervention group |
Primary outcome
Change in Brief Symptom Inventory Scores
Time frame: 1 month post-intervention
The Brief Symptom Inventory is a a broad-spectrum measure of psychopathology covering 9 symptom dimensions: Somatization, Obsessive-compulsive symptoms, Interpersonal sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation, and Psychoticism. The BSI includes a global index of distress (the General Severity Index, GSI) that reflects the mean of all items, which is used here. The GSI ranges between 0 to 4, higher scores indicative of a higher degree of symptom severity.
Change in Brief Symptom Inventory Scores
Time frame: 6 month post-intervention
The Brief Symptom Inventory is a a broad-spectrum measure of psychopathology covering 9 symptom dimensions: Somatization, Obsessive-compulsive symptoms, Interpersonal sensitivity, Depression, Anxiety, Hostility, Phobic anxiety, Paranoid ideation, and Psychoticism. The BSI also includes a global index of distress (the General Severity Index, GSI) that reflects the mean of all items, which is used here. The GSI ranges between 0 to 4, higher scores indicative of a higher degree of symptom severity.
14 secondary outcomes
Change in Eating Disorder Risk Assessed by the SCOFF Screening Test
Time frame: 1 month post-intervention
Change in Eating Disorder Risk Assessed by the SCOFF Screening Test
Time frame: 6 month post-intervention
Change in Substance- and Behavioral Addiction Severity Assessed by the SSBA-G
Time frame: 1 month post-intervention
Change in Substance- and Behavioral Addiction Severity Assessed by the SSBA-G
Time frame: 6 month post-intervention
Change in Quality of Life Specific to Interpersonal Relationships Using the Experience in Personal Social Systems Questionnaire (EXIS.Pers)
Time frame: 1 month post-intervention
Change in Quality of Life Specific to Interpersonal Relationships Using the Experience in Personal Social Systems Questionnaire (EXIS.Pers)
Time frame: 6 month post-intervention
Change in Perceived Level of Meaning in Life Using the Meaning in Life Questionnaire (MLQ)
Time frame: 1 month post-intervention
Change in Perceived Level of Meaning in Life Using the Meaning in Life Questionnaire (MLQ)
Time frame: 6 month post-intervention
Change in Life Satisfaction Using the Satisfaction With Life Scale (SWLS)
Time frame: 1 month post-intervention
Change in Life Satisfaction Using the Satisfaction With Life Scale (SWLS)
Time frame: 6 month post-intervention
Change in General Well-being Using the 5-item Version of the WHO Wellbeing Index (WBI-5)
Time frame: 1 month post-intervention
Change in General Well-being Using the 5-item Version of the WHO Wellbeing Index (WBI-5)
Time frame: 6 month post-intervention
Perceived Negative Effects of the Intervention Using ad Hoc Questions
Time frame: 1 month post-intervention
Perceived Negative Effects of the Intervention Using ad Hoc Questions
Time frame: 6 month post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33528854Konkoly Thege B, Petroll C, Rivas C, Scholtens S. The Effectiveness of Family Constellation Therapy in Improving Mental Health: A Systematic Review. Fam Process. 2021 Jun;60(2):409-423. doi: 10.1111/famp.12636. Epub 2021 Feb 2.
- Background: PubMed 23957767Weinhold J, Hunger C, Bornhauser A, Link L, Rochon J, Wild B, Schweitzer J. Family constellation seminars improve psychological functioning in a general population sample: results of a randomized controlled trial. J Couns Psychol. 2013 Oct;60(4):601-9. doi: 10.1037/a0033539. Epub 2013 Aug 19.
- Results publication: PubMed 39053295Konkoly Thege B, Szabo GS. The efficacy of pandemic-adjusted family/systemic constellation therapy in improving psychopathological symptoms: A randomized controlled trial. J Psychiatr Res. 2024 Sep;177:271-278. doi: 10.1016/j.jpsychires.2024.07.027. Epub 2024 Jul 18.
- Individual participant dataSharing planned: No. The authors are concerned that making individual participant data available to others would seriously jeopardize participants' willingness to participate in the study. Therefore, the authors offer that they will conduct any alternative analyses on the data set other researchers are interested in and the authors will share the raw output of those analyses including the analytical syntaxes.
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.
Barna Konkoly-Thege, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family / systemic constellation therapy in people with Mild to Moderate Psychopathological Symptoms, run by Károli Gáspár University of the Reformed Church in Hungary at 1 site in Hungary.
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 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: finished, as of the sponsor's last update on 26 Sep 2025. 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 Hungary. 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 26 Sep 2025). 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?
Change in Brief Symptom Inventory Scores (time frame: 1 month post-intervention). 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 NCT05051462, 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 26 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.