Major Depressive DisorderNCT03287362
Effects of Schema Therapy vs. Cognitive Behavioral Therapy vs. Individual Supportive Therapy
A study testing schema therapy, cognitive behavioral therapy and individualized supportive therapy in people with Major Depressive Disorder, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
Trial summary
The OPTIMA-Study: Optimized Treatment Identification at the Max Planck Institute of Psychiatry: An outline Depressive disorders represent one of the most frequent diseases worldwide. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- schema therapy, cognitive behavioral therapy and individualized supportive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- 13 Sep 2017to 31 Dec 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Main diagnosis of major depressive disorder, single episode or recurrent, moderate or severe without psychotic symptoms according to DSM-5 criteria (F32.1, F32.2, F33.1, F33.2 according to ICD-10)
- age between 18 and 75 years
- informed consent to the study procedures and assessments (in written form)
Who cannot join
- Major depressive disorder, single episode or recurrent, severe with psychotic symptoms (F32.3, F33.3 according to ICD-10)
- Severe mutism or stupor
- lifetime history of any psychotic or bipolar disorder
- severe neurological or internal concomitant diseases
- IQ < 80; severe learning disability, brain damage or pervasive developmental disorder
- current alcohol or any illicit drug withdrawal syndrome according to DSM-5
Show all 12Show fewer
- mental disorders secondary to a medical conditions or substance use disorders
- acute suicidality
- pregnancy and lactation period
- Missing eligibility for psychotherapy because of missing language skills
- Electroconvulsive therapy (ECT) in preparation
- Participation in further scientific studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The OPTIMA-Study: Optimized Treatment Identification at the Max Planck Institute of Psychiatry
The OPTIMA-Study: Optimized Treatment Identification at the Max Planck Institute of Psychiatry: An outline
Depressive disorders represent one of the most frequent diseases worldwide. Schema therapy, which was originally developed for patients with personality disorders and focuses on emotion activating techniques, became popular in the field of psychotherapy in the recent years and was also applied on axis-I-disorders such as depression.
Read more
The current study aims to close the gap of increasing popularity of ST and missing empirical evidence of its effectiveness. This aim breaks down into three main research questions dealing with (1) general effectiveness of ST measured by multiple operationalizations (i.e. depressive symptoms, biological markers, relapse prevention, or need for medication), (2) specific effectiveness of ST (i.e. interpersonal problems and emotion regulation), and (3) the identification of parameters in the sense of an individualized psychotherapy approach in order to fit patient needs with certain psychotherapy offers.
After participants have given informed consent, they undergo a comprehensive baseline measurement which covers psychometric measures (such as questionnaires and clinical ratings), biological parameters (blood samples, endocrine activity), neuropsychological testing (such as word fluency), and actimetry measures (circadian rhythms).
After finishing the diagnostic procedure, participants will be randomized to three different experimental conditions: (1) a schema therapy condition, (2) a cognitive behavioral therapy condition, and (3) an individualized supportive therapy condition. After undergoing a comprehensive baseline measurement process in study week one, patients participate in an intensive seven-week-treatment-program, in addition to the regular pharmacological treatment, which is not object of the study. The measures are repeated during the fourth and seventh week of psychotherapeutical treatment and on the occasion of a follow-up visit six months after discharge from the clinic.
Additionally, the investigators test among sub-samples the effects of psychotherapeutical interventions on psychophysiological outcomes, sleep-patterns, and neuronal substrates in the context of emotional regulation and social interaction.
Thus, the study will give valuables insights in the effectiveness of an innovative psychotherapy approach and breaks new ground in the field of individualized psychotherapy and its biological implications.
- Conditions
- Major Depressive Disorder
- Being tested
- schema therapy, cognitive behavioral therapy, individualized supportive therapy
- Keywords
- major depressive disorder, cognitive behavioral therapy, supportive therapy, schema therapy, biomarkers, neuropsychology, circadian rhythm
- 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.
schema therapyBehavioural
The intervention consists of a seven-week program of schema therapy, which is a further development of cognitive behavioral therapy, designed in a three-phase combined group and single session concept
cognitive behavioral therapyBehavioural
The intervention consists of a seven-week program of cognitive behavioral therapy, which is the current gold standard of treatment
individualized supportive therapyBehavioural
The intervention consists of a seven-week program of individualized supportive therapy, including different therapeutic offers from the clinic and a high frequency of physician contacts.
| Study group | Role | What they receive |
|---|---|---|
| ST-arm | Experimental | one-third of the patients is randomized to schema therapy Receives: Behavioral: schema therapy |
| CBT-arm | Active comparator | one-third of the patients is randomized to cognitive behavioral therapy Receives: Behavioral: cognitive behavioral therapy |
| IST-arm | Placebo comparator | one-third of the patients is randomized to individualized supportive therapy Receives: Behavioral: individualized supportive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
BDI-II (Beck-Depression-Inventory-II)
Decrease in depression symptoms, measured by "benefit" changes in scores of BDI-II (Beck-Depression-Inventory-II) questionnaire (self rating) from baseline over the course of seven weeks of treatment up to six months after discharge from the clinic
Measured: Assessed as baseline measure after informed consent was given, and on a weekly base over the course of seven weeks of treatment. Additionally in a follow-up assessment six months after discharge from the clinic.
Secondary outcomes (8)
MADRS (Montgomery-Åsberg Depression Rating Scale)
Decrease in depression symptoms, "benefit" changes from baseline to week 4 and 7 of treatment up to six months after discharge from the clinic, clinical rating
Measured: Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment.Additionally in a follow-up assessment six months after discharge from the clinic.
CIDI (Composite International Diagnostic Interview)
Decrease in symptoms or recovery from DSM-5 diagnosis of depression, "benefit" changes from baseline to week 7 of treatment and up to six months after discharge from the clinic
Measured: Assessed as baseline measure after informed consent was given, in week 7 of the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.
BSI (Brief Symptom Inventory)
Decrease in general psychopathology, "benefit" changes from baseline over the course of seven weeks of treatment up to six months after discharge from the clinic
Measured: Assessed as baseline measure after informed consent was given, and on a weekly base over the course of seven weeks of treatment. Additionally in a follow-up assessment six months after discharge from the clinic.
WHOQOL (WHO - Quality of Life)
Increase in quality of life, "benefit" changes from baseline to week 4 and 7 of treatment and up to six months after discharge from the clinic
Measured: Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.
Neuropsychological testing (including sections on episodic memory, working memory, inhibition, cognitive flexibility, word fluency, sensitivity to interference, and attention)
Increase of cognitive functioning, "benefit" changes from baseline to week 4 and 7 of treatment and up to six months after discharge from the clinic
Measured: Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.
Decreased need for psychopharmacological medication
Measured: Comparison between baseline measurement before treatment start and end of therapy treatment of seven weeks
Dropout rate from therapeutic treatment
Measured: Assessed after all participants were recruited, enrolled, treated and finished their final measurements (approx. after eight years)
WHODAS (WHO-Disability Assessment Schedule)
Decrease in symptoms or recovery from DSM-5 diagnosis of depression, "benefit" changes from baseline to week 7 of treatment and up to six months after discharge from the clinic
Measured: Assessed as baseline measure after informed consent was given, in week 7 of the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start13 Sep 2017
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Major Depressive 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
- Model description
- Incoming patients from the clinic of Max Planck Institute of Psychiatry are continuously screened for study eligibility and - after they have given informed consent - are block wise randomly assigned to one of 3 study arms (schema therapy, cognitive behavioral therapy, individual supportive therapy)
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Max-Planck-Institute of Psychiatry
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Responsible party
- Sponsor
- Investigators
- Johannes M. Kopf-Beck, PhD, Principal investigator, Max-Planck-Institute of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287362
- Sponsor's protocol ID
- 17-395
- Status last verified
- May 2025
- First submitted
- 25 Aug 2017
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Renner F, van Goor M, Huibers M, Arntz A, Butz B, Bernstein D. Short-term group schema cognitive-behavioral therapy for young adults with personality disorders and personality disorder features: associations with changes in symptomatic distress, schemas, schema modes and coping styles. Behav Res Ther. 2013 Aug;51(8):487-92. doi: 10.1016/j.brat.2013.05.011. Epub 2013 May 31.
PubMed 23778056Ferrari AJ, Charlson FJ, Norman RE, Patten SB, Freedman G, Murray CJ, Vos T, Whiteford HA. Burden of depressive disorders by country, sex, age, and year: findings from the global burden of disease study 2010. PLoS Med. 2013 Nov;10(11):e1001547. doi: 10.1371/journal.pmed.1001547. Epub 2013 Nov 5.
PubMed 24223526Kirchler SV, Muller CL, Spock Z, Ehring T, Kopf-Beck J, Tamm J. The role of concreteness in repetitive negative thinking: Temporal dynamics and the predictive value for depression throughout psychological treatment. Behav Res Ther. 2025 Sep;192:104801. doi: 10.1016/j.brat.2025.104801. Epub 2025 Jun 11.
PubMed 40544720Tamm J, Takano K, Just L, Ehring T, Rosenkranz T, Kopf-Beck J. Ecological Momentary Assessment versus Weekly Questionnaire Assessment of Change in Depression. Depress Anxiety. 2024 Jul 11;2024:9191823. doi: 10.1155/2024/9191823. eCollection 2024.
PubMed 40226649Kopf-Beck J, Muller CL, Tamm J, Fietz J, Rek N, Just L, Spock ZI, Weweck K, Takano K, Rein M, Keck ME, Egli S. Effectiveness of Schema Therapy versus Cognitive Behavioral Therapy versus Supportive Therapy for Depression in Inpatient and Day Clinic Settings: A Randomized Clinical Trial. Psychother Psychosom. 2024;93(1):24-35. doi: 10.1159/000535492. Epub 2024 Jan 4.
PubMed 38176391Kopf-Beck J, Zimmermann P, Egli S, Rein M, Kappelmann N, Fietz J, Tamm J, Rek K, Lucae S, Brem AK, Samann P, Schilbach L, Keck ME. Schema therapy versus cognitive behavioral therapy versus individual supportive therapy for depression in an inpatient and day clinic setting: study protocol of the OPTIMA-RCT. BMC Psychiatry. 2020 Oct 14;20(1):506. doi: 10.1186/s12888-020-02880-x.
PubMed 33054737
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The OPTIMA-Study: Optimized Treatment Identification at the Max Planck Institute of Psychiatry
- ClinicalTrials.gov ID
- NCT03287362
- Acronym / sponsor ID
- 17-395
- Conditions
- Major Depressive Disorder
- Keywords
- major depressive disorder, cognitive behavioral therapy, supportive therapy, schema therapy, biomarkers, neuropsychology, circadian rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Max-Planck-Institute of PsychiatryUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Sep 2017 (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 OPTIMA-Study: Optimized Treatment Identification at the Max Planck Institute of Psychiatry: An outline
Depressive disorders represent one of the most frequent diseases worldwide. Schema therapy, which was originally developed for patients with personality disorders and focuses on emotion activating techniques, became popular in the field of psychotherapy in the recent years and was also applied on axis-I-disorders such as depression.
The current study aims to close the gap of increasing popularity of ST and missing empirical evidence of its effectiveness. This aim breaks down into three main research questions dealing with (1) general effectiveness of ST measured by multiple operationalizations (i.e. depressive symptoms, biological markers, relapse prevention, or need for medication), (2) specific effectiveness of ST (i.e. interpersonal problems and emotion regulation), and (3) the identification of parameters in the sense of an individualized psychotherapy approach in order to fit patient needs with certain psychotherapy offers.
After participants have given informed consent, they undergo a comprehensive baseline measurement which covers psychometric measures (such as questionnaires and clinical ratings), biological parameters (blood samples, endocrine activity), neuropsychological testing (such as word fluency), and actimetry measures (circadian rhythms).
After finishing the diagnostic procedure, participants will be randomized to three different experimental conditions: (1) a schema therapy condition, (2) a cognitive behavioral therapy condition, and (3) an individualized supportive therapy condition. After undergoing a comprehensive baseline measurement process in study week one, patients participate in an intensive seven-week-treatment-program, in addition to the regular pharmacological treatment, which is not object of the study. The measures are repeated during the fourth and seventh week of psychotherapeutical treatment and on the occasion of a follow-up visit six months after discharge from the clinic.
Additionally, the investigators test among sub-samples the effects of psychotherapeutical interventions on psychophysiological outcomes, sleep-patterns, and neuronal substrates in the context of emotional regulation and social interaction.
Thus, the study will give valuables insights in the effectiveness of an innovative psychotherapy approach and breaks new ground in the field of individualized psychotherapy and its biological implications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Incoming patients from the clinic of Max Planck Institute of Psychiatry are continuously screened for study eligibility and - after they have given informed consent - are block wise randomly assigned to one of 3 study arms (schema therapy, cognitive behavioral therapy, individual supportive therapy)
| Arm | Type | Receives |
|---|---|---|
| ST-arm | Experimental | Behavioral: schema therapyone-third of the patients is randomized to schema therapy |
| CBT-arm | Active comparator | Behavioral: cognitive behavioral therapyone-third of the patients is randomized to cognitive behavioral therapy |
| IST-arm | Placebo comparator | Behavioral: individualized supportive therapyone-third of the patients is randomized to individualized supportive therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Main diagnosis of major depressive disorder, single episode or recurrent, moderate or severe without psychotic symptoms according to DSM-5 criteria (F32.1, F32.2, F33.1, F33.2 according to ICD-10)
- age between 18 and 75 years
- informed consent to the study procedures and assessments (in written form)
Key exclusion criteria (12 listed)
- Major depressive disorder, single episode or recurrent, severe with psychotic symptoms (F32.3, F33.3 according to ICD-10)
- Severe mutism or stupor
- lifetime history of any psychotic or bipolar disorder
- severe neurological or internal concomitant diseases
- IQ < 80; severe learning disability, brain damage or pervasive developmental disorder
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 |
|---|---|---|
| schema therapyThe intervention consists of a seven-week program of schema therapy, which is a further development of cognitive behavioral therapy, designed in a three-phase combined group and single session concept | Behavioural | ST-arm |
| cognitive behavioral therapyThe intervention consists of a seven-week program of cognitive behavioral therapy, which is the current gold standard of treatment | Behavioural | CBT-arm |
| individualized supportive therapyThe intervention consists of a seven-week program of individualized supportive therapy, including different therapeutic offers from the clinic and a high frequency of physician contacts. | Behavioural | IST-arm |
Primary outcome
BDI-II (Beck-Depression-Inventory-II)
Time frame: Assessed as baseline measure after informed consent was given, and on a weekly base over the course of seven weeks of treatment. Additionally in a follow-up assessment six months after discharge from the clinic.
Decrease in depression symptoms, measured by "benefit" changes in scores of BDI-II (Beck-Depression-Inventory-II) questionnaire (self rating) from baseline over the course of seven weeks of treatment up to six months after discharge from the clinic
8 secondary outcomes
MADRS (Montgomery-Åsberg Depression Rating Scale)
Time frame: Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment.Additionally in a follow-up assessment six months after discharge from the clinic.
CIDI (Composite International Diagnostic Interview)
Time frame: Assessed as baseline measure after informed consent was given, in week 7 of the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.
BSI (Brief Symptom Inventory)
Time frame: Assessed as baseline measure after informed consent was given, and on a weekly base over the course of seven weeks of treatment. Additionally in a follow-up assessment six months after discharge from the clinic.
WHOQOL (WHO - Quality of Life)
Time frame: Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.
Neuropsychological testing (including sections on episodic memory, working memory, inhibition, cognitive flexibility, word fluency, sensitivity to interference, and attention)
Time frame: Assessed as baseline measure after informed consent was given, in week 4 and 7 of the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.
Decreased need for psychopharmacological medication
Time frame: Comparison between baseline measurement before treatment start and end of therapy treatment of seven weeks
Dropout rate from therapeutic treatment
Time frame: Assessed after all participants were recruited, enrolled, treated and finished their final measurements (approx. after eight years)
WHODAS (WHO-Disability Assessment Schedule)
Time frame: Assessed as baseline measure after informed consent was given, in week 7 of the treatment. Additionally in a follow-up assessment six months after discharge from the clinic.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Background: PubMed 23778056Renner F, van Goor M, Huibers M, Arntz A, Butz B, Bernstein D. Short-term group schema cognitive-behavioral therapy for young adults with personality disorders and personality disorder features: associations with changes in symptomatic distress, schemas, schema modes and coping styles. Behav Res Ther. 2013 Aug;51(8):487-92. doi: 10.1016/j.brat.2013.05.011. Epub 2013 May 31.
- Background: PubMed 24223526Ferrari AJ, Charlson FJ, Norman RE, Patten SB, Freedman G, Murray CJ, Vos T, Whiteford HA. Burden of depressive disorders by country, sex, age, and year: findings from the global burden of disease study 2010. PLoS Med. 2013 Nov;10(11):e1001547. doi: 10.1371/journal.pmed.1001547. Epub 2013 Nov 5.
- Derived from this study: PubMed 40544720Kirchler SV, Muller CL, Spock Z, Ehring T, Kopf-Beck J, Tamm J. The role of concreteness in repetitive negative thinking: Temporal dynamics and the predictive value for depression throughout psychological treatment. Behav Res Ther. 2025 Sep;192:104801. doi: 10.1016/j.brat.2025.104801. Epub 2025 Jun 11.
- Derived from this study: PubMed 40226649Tamm J, Takano K, Just L, Ehring T, Rosenkranz T, Kopf-Beck J. Ecological Momentary Assessment versus Weekly Questionnaire Assessment of Change in Depression. Depress Anxiety. 2024 Jul 11;2024:9191823. doi: 10.1155/2024/9191823. eCollection 2024.
- Derived from this study: PubMed 38176391Kopf-Beck J, Muller CL, Tamm J, Fietz J, Rek N, Just L, Spock ZI, Weweck K, Takano K, Rein M, Keck ME, Egli S. Effectiveness of Schema Therapy versus Cognitive Behavioral Therapy versus Supportive Therapy for Depression in Inpatient and Day Clinic Settings: A Randomized Clinical Trial. Psychother Psychosom. 2024;93(1):24-35. doi: 10.1159/000535492. Epub 2024 Jan 4.
- Derived from this study: PubMed 33054737Kopf-Beck J, Zimmermann P, Egli S, Rein M, Kappelmann N, Fietz J, Tamm J, Rek K, Lucae S, Brem AK, Samann P, Schilbach L, Keck ME. Schema therapy versus cognitive behavioral therapy versus individual supportive therapy for depression in an inpatient and day clinic setting: study protocol of the OPTIMA-RCT. BMC Psychiatry. 2020 Oct 14;20(1):506. doi: 10.1186/s12888-020-02880-x.
- Individual participant dataSharing planned: No
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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.
Johannes M. Kopf-Beck, PhD principal investigator
Max-Planck-Institute of Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing schema therapy, cognitive behavioral therapy and individualized supportive therapy in people with Major Depressive Disorder, run by Max-Planck-Institute of Psychiatry at 1 site in Germany.
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 3 inclusion and 12 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 13 May 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BDI-II (Beck-Depression-Inventory-II) (time frame: Assessed as baseline measure after informed consent was given, and on a weekly base over the course of seven weeks of treatment. Additionally in a follow-up assessment six months after discharge from the clinic.). 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 NCT03287362, which also lists 6 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 13 May 2025.