Obsessive-Compulsive DisorderNCT03002753
Dealing With Intrusive Thoughts in OCD - a Comparison of Detached Mindfulness and Cognitive Restructuring
A study testing detached mindfulness and cognitive restructuring in people with Obsessive-Compulsive Disorder, run by Christoph-Dornier-Stiftung für Klinische Psychologie at 1 site in Germany.
Trial summary
The purpose of this study is to assess and compare the overall efficacy and differential effects of detached mindfulness and cognitive restructuring in the treatment of patients with obsessive-compulsive disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obsessive-Compulsive Disorder
- What is being tested?
- detached mindfulness and cognitive restructuring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2016to 12 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of OCD according to DSM-5
- Minimum age of 18 years
- Sufficient German language skills
Who cannot join
- A mental disorder other then OCD constituting the primary diagnosis (such as depression)
- Verbal IQ <80 as measured with the MWT-B (Lehrl, 2005)
- Presence of an acute suicidal tendency or suicidal behavior in the past 6 months
- Presence of an acute psychosis or assured diagnosis of psychosis and related disorders
- Presence of an acute manic episode
- Presence of an acute borderline personality disorder
Show all 10Show fewer
- Presence of a comorbid addictive disorder
- Present psychotherapeutic treatment including OCD-focused CBT elements
- Psychotherapeutic treatment including OCD-focused CBT elements within the past 12 months
- For individuals with psychotropic medication, a change of substance or dose within the past 8 weeks
Trial locations and contacts
1 site in 1 country.
Germany1 site
Christoph-Dornier-Stiftung für Klinische Psychologie
Münster, North Rhine-Westphalia, 48143
About this study
Official title: Zum Umgang Mit Aufdringlichen Gedanken Bei Der Zwangsstörung - Zwei Behandlungsstrategien im Vergleich
The purpose of this study is to assess and compare the overall efficacy and differential effects of detached mindfulness and cognitive restructuring in the treatment of patients with obsessive-compulsive disorder.
Read the detailed description
The purpose of this study is to assess and compare the overall efficacy and differential effects of two interventions for patients suffering from obsessive-compulsive disorder (OCD) according to DSM-5. The interventions to be compared are detached mindfulness (DM) and cognitive restructuring (CR). Whereas the efficacy of CR for the treatment of OCD has been proven in various studies, the efficacy of DM as a single intervention so far has only been shown within a case study and within a non-clinical sample. By contrast, the efficacy of complex metacognitive protocols (of which DM constitutes one of several single interventions) has been shown multiple times. So far, however, little is known about the efficacy of DM as a single intervention in a clinical sample and the differential working mechanisms of DM vs. CR.
Whereas DM is supposed to modify metacognitions by teaching patients to solely observe their intrusive thoughts, CR aims at teaching the patients to actively question and modify their distorted interpretations of their intrusions. Since previous research has shown that symptom reduction is mediated by a change in metacognition but not by a change of distorted interpretations, the investigators hypothesize that, while expecting both interventions to be similarly effective on an overall scale, DM will lead to a change in both metacognitions and distorted interpretations whereas CR will predominantly have an effect on distorted interpretations while influencing metacognitions to a lesser extent. Further research questions address differences concerning the applicability of the two interventions in patients' everyday life and the degree to which an intense psychoeducation can already have an effect on the participants' overall symptom burden.
The intervention (both DM and CR) is spread over four sessions of 100 min each taking place within two weeks (i.e. two sessions per week) and includes intensive homework assignments for the patients. The intervention will be delivered by MSc-level clinical psychologists completing the clinical training for becoming a licenced psychotherapist in Germany ("Psychologischer Psychotherapeut"). The diagnostic assessment involves clinical interviews and a number of questionnaires and will be conducted by independent assessors who have a qualification similar to the study therapists. Assessment involves pre-, post- and follow-up assessment. Additionally, assessment comprises data collection via ecological momentary assessment (EMA) in order to measure OCD symptoms (intrusions, emotions and coping strategies), the degree to which participants apply the newly learned strategy (DM or CR) in everyday life and the amount of relief experienced from applying it. There will be one EMA before (Pre-EMA) and one after the intervention (Post-EMA). For EMA, participants receive a smartphone for four days each (Friday to Monday) and are randomly prompted ten times per day to fill in a short questionnaire. The average amount of time necessary to fill in the questionnaire is assumed to be less than 2 min, based on a sample trial with mentally healthy participants.
Participants will be randomly assigned to one of three groups: 1) DM, 2) CR, and 3) a waitlist control group. The waitlist control group will wait for two weeks (i.e., as long as the intervention in the other two groups last), before participants will be once more randomly assigned to one of the two active conditions (DM and CR), which they will then regularly participate in. Thus, all participants enrolled in the study receive one of the two treatments sooner or later. For participants who are initially assigned to the waitlist group, there will be a second pre-assessment prior to the start of the intervention.
The study is going to be sponsored by the Christoph-Dornier-Stiftung für Klinische Psychologie, which is a non-profit organization that supports research in clinical psychology and awards PhD scholarships to clinical psychologists. The study at hand is the major part of the PhD project of Christian Rupp, M. Sc., and Charlotte Juergens, M. Sc., who are currently holding a PhD scholarship by the Christoph-Dornier-Stiftung für Klinische Psychologie. The Christoph-Dornier-Stiftung für Klinische Psychologie collaborates with Department of Clinical Psychology at the University of Muenster (Westfälische Wilhelms-Universität). The The PhD project is being supervised scientifically by Principal Investigator Prof. Dr. Ulrike Buhlmann, who is a professor of clinical psychology at the University of Muenster (Westfälische Wilhelms-Universität), Germany.
- Conditions
- Obsessive-Compulsive Disorder
- Being tested
- detached mindfulness, cognitive restructuring
- Keywords
- OCD, obsessive-compulsive disorder, cognitive therapy, metacognitive therapy, cognitive restructuring, detached mindfulness, comparison, Germany, Muenster, Christoph-Dornier-Stiftung, metacognition
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
detached mindfulnessBehavioural
Please see detailed study description.
cognitive restructuringBehavioural
Please see detailed study description.
| Study group | Role | What they receive |
|---|---|---|
| DM | Experimental | Group of patients receiving detached mindfulness (for details, see detailed description of the study) Receives: Behavioral: detached mindfulness |
| CR | Active comparator | Group of patients receiving cognitive restructuring (for details, see detailed description of the study) Receives: Behavioral: cognitive restructuring |
| WL | No intervention | Waitlist control group, which, however, is again randomized after the waiting time in order to receive one of the two interventions (DM or CR). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Y-BOCS Change Score (Pre to Post Assessment)
German version of the Yale-Brown Obsessive Compulsive Scale (Hand \& Büttner-Westphal, 1991). The mininum value is 0, the maximal value is 40. Higher scores indicate a higher symptom severity of obsessive-compulsive disorder.
Measured: Difference score resulting from (a) first baseline minus post-treatment (non-waitlist) or (b) first baseline minus second baseline (waitlist). In both cases, there are 2 weeks between the two measurements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion12 Jul 2018
- Study completion12 Jul 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 (23)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive 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
- Participant, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christoph-Dornier-Stiftung für Klinische Psychologie
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Münster
- Responsible party
- Principal investigator, Prof. Dr. Ulrike Buhlmann, Universität Münster
- Investigators
- Ulrike Buhlmann, Prof. Dr., Principal investigator, Universität Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002753
- Sponsor's protocol ID
- CDS-MS-JR-2016
- Status last verified
- Apr 2019
- First submitted
- 14 Dec 2016
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Myers SG, Fisher PL, Wells A. An empirical test of the metacognitive model of obsessive-compulsive symptoms: fusion beliefs, beliefs about rituals, and stop signals. J Anxiety Disord. 2009 May;23(4):436-42. doi: 10.1016/j.janxdis.2008.08.007. Epub 2008 Sep 3.
PubMed 18922674Solem S, Haland AT, Vogel PA, Hansen B, Wells A. Change in metacognitions predicts outcome in obsessive-compulsive disorder patients undergoing treatment with exposure and response prevention. Behav Res Ther. 2009 Apr;47(4):301-7. doi: 10.1016/j.brat.2009.01.003. Epub 2009 Jan 17.
PubMed 19203749Gonner S, Leonhart R, Ecker W. [The German version of the obsessive-compulsive inventory-revised: a brief self-report measure for the multidimensional assessment of obsessive-compulsive symptoms]. Psychother Psychosom Med Psychol. 2007 Sep-Oct;57(9-10):395-404. doi: 10.1055/s-2007-970894. German.
PubMed 17590836Baer L. Alles unter Kontrolle: Zwangsgedanken und Zwangshandlungen überwinden. Bern: Hans Huber, 1993.
Ertle A, Wahl K, Bohne A, Moritz S, Kordon A, Schulte D. Dimensionen zwangsspezifischer Einstellungen: Der Obsessive-Beliefs Questionnaire (OBQ) für den deutschen Sprachraum analysiert. Zeitschrift für Klinische Psychologie und Psychotherapie 37: 263-271, 2008.
Hand I, Büttner-Westphal H. Die Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Ein halbstrukturiertes Interview zur Beurteilung des Schweregrades von Denk- und Handlungszwängen. Verhaltenstherapie 1: 223-225, 1991.
Wells A, Gwilliam P, Cartwright-Hatton S. Thought-Fusion-Instrument (TFI, unpublished manuscript). University of Manchester, UK, 2002.
Schulte D. Messung der Therapieerwartung und Therapieevaluation von Patienten (PATHEV). Zeitschrift für Klinische Psychologie und Psychotherapie 34(3): 176-187, 2005.
Hautzinger M, Keller F, Kühner C. BDI II. Beck Depressions Inventar. Revision. Frankfurt/Main: Harcourt Test Service, 2006.
Wells A, McNicol K. Beliefs About Rituals Inventory (BARI, unpublished manuscript). University of Manchester, UK, 2004.
Wells A. Metacognitive therapy for anxiety and depression. Guilford press, 2011.
Wilhelm S, Steketee GS. Cognitive therapy for obsessive compulsive disorder: A guide for professionals. New Harbinger Publications, 2006.
American Psychiatric Association. Diagnostic and statistical manual of mental disorders, Fourth Edition, Text Revision (DSM-IV-TR). Washington, DC: American Psychiatric Association, 2000.
Wittchen HU, Wunderlich U, Gruschwitz S, Zaudig M. SKID I. Strukturiertes Klinisches Interview für DSM-IV. Achse I: Psychische Störungen. Interviewheft und Beurteilungsheft. Eine deutschsprachige, erweiterte Bearb. d. amerikanischen Originalversion des SKID I., 1997.
Lehrl S. MWT-B Mehrfachwahl-Wortschatz-Intelligenztest. Balingen: Spitta-Verlag, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zum Umgang Mit Aufdringlichen Gedanken Bei Der Zwangsstörung - Zwei Behandlungsstrategien im Vergleich
- ClinicalTrials.gov ID
- NCT03002753
- Acronym / sponsor ID
- CDS-MS-JR-2016
- Conditions
- Obsessive-Compulsive Disorder
- Keywords
- OCD, obsessive-compulsive disorder, cognitive therapy, metacognitive therapy, cognitive restructuring, detached mindfulness, comparison, Germany
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Christoph-Dornier-Stiftung für Klinische PsychologieUniversity, hospital or other
- Collaborators
- Universität Münster
- Study start
- Dec 2016 (actual)
- Primary completion
- 12 Jul 2018 (actual)
- Study completion
- 12 Jul 2018 (actual)
- First posted
- 26 Dec 2016 (estimated)
- Results
- Posted 16 Apr 2019
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 assess and compare the overall efficacy and differential effects of detached mindfulness and cognitive restructuring in the treatment of patients with obsessive-compulsive disorder.
Detailed description
The purpose of this study is to assess and compare the overall efficacy and differential effects of two interventions for patients suffering from obsessive-compulsive disorder (OCD) according to DSM-5. The interventions to be compared are detached mindfulness (DM) and cognitive restructuring (CR). Whereas the efficacy of CR for the treatment of OCD has been proven in various studies, the efficacy of DM as a single intervention so far has only been shown within a case study and within a non-clinical sample. By contrast, the efficacy of complex metacognitive protocols (of which DM constitutes one of several single interventions) has been shown multiple times. So far, however, little is known about the efficacy of DM as a single intervention in a clinical sample and the differential working mechanisms of DM vs. CR.
Whereas DM is supposed to modify metacognitions by teaching patients to solely observe their intrusive thoughts, CR aims at teaching the patients to actively question and modify their distorted interpretations of their intrusions. Since previous research has shown that symptom reduction is mediated by a change in metacognition but not by a change of distorted interpretations, the investigators hypothesize that, while expecting both interventions to be similarly effective on an overall scale, DM will lead to a change in both metacognitions and distorted interpretations whereas CR will predominantly have an effect on distorted interpretations while influencing metacognitions to a lesser extent. Further research questions address differences concerning the applicability of the two interventions in patients' everyday life and the degree to which an intense psychoeducation can already have an effect on the participants' overall symptom burden.
The intervention (both DM and CR) is spread over four sessions of 100 min each taking place within two weeks (i.e. two sessions per week) and includes intensive homework assignments for the patients. The intervention will be delivered by MSc-level clinical psychologists completing the clinical training for becoming a licenced psychotherapist in Germany ("Psychologischer Psychotherapeut"). The diagnostic assessment involves clinical interviews and a number of questionnaires and will be conducted by independent assessors who have a qualification similar to the study therapists. Assessment involves pre-, post- and follow-up assessment. Additionally, assessment comprises data collection via ecological momentary assessment (EMA) in order to measure OCD symptoms (intrusions, emotions and coping strategies), the degree to which participants apply the newly learned strategy (DM or CR) in everyday life and the amount of relief experienced from applying it. There will be one EMA before (Pre-EMA) and one after the intervention (Post-EMA). For EMA, participants receive a smartphone for four days each (Friday to Monday) and are randomly prompted ten times per day to fill in a short questionnaire. The average amount of time necessary to fill in the questionnaire is assumed to be less than 2 min, based on a sample trial with mentally healthy participants.
Participants will be randomly assigned to one of three groups: 1) DM, 2) CR, and 3) a waitlist control group. The waitlist control group will wait for two weeks (i.e., as long as the intervention in the other two groups last), before participants will be once more randomly assigned to one of the two active conditions (DM and CR), which they will then regularly participate in. Thus, all participants enrolled in the study receive one of the two treatments sooner or later. For participants who are initially assigned to the waitlist group, there will be a second pre-assessment prior to the start of the intervention.
The study is going to be sponsored by the Christoph-Dornier-Stiftung für Klinische Psychologie, which is a non-profit organization that supports research in clinical psychology and awards PhD scholarships to clinical psychologists. The study at hand is the major part of the PhD project of Christian Rupp, M. Sc., and Charlotte Juergens, M. Sc., who are currently holding a PhD scholarship by the Christoph-Dornier-Stiftung für Klinische Psychologie. The Christoph-Dornier-Stiftung für Klinische Psychologie collaborates with Department of Clinical Psychology at the University of Muenster (Westfälische Wilhelms-Universität). The The PhD project is being supervised scientifically by Principal Investigator Prof. Dr. Ulrike Buhlmann, who is a professor of clinical psychology at the University of Muenster (Westfälische Wilhelms-Universität), Germany.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DM | Experimental | Behavioral: detached mindfulnessGroup of patients receiving detached mindfulness (for details, see detailed description of the study) |
| CR | Active comparator | Behavioral: cognitive restructuringGroup of patients receiving cognitive restructuring (for details, see detailed description of the study) |
| WL | No intervention | –Waitlist control group, which, however, is again randomized after the waiting time in order to receive one of the two interventions (DM or CR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A diagnosis of OCD according to DSM-5
- Minimum age of 18 years
- Sufficient German language skills
Key exclusion criteria (10 listed)
- A mental disorder other then OCD constituting the primary diagnosis (such as depression)
- Verbal IQ <80 as measured with the MWT-B (Lehrl, 2005)
- Presence of an acute suicidal tendency or suicidal behavior in the past 6 months
- Presence of an acute psychosis or assured diagnosis of psychosis and related disorders
- Presence of an acute manic episode
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 |
|---|---|---|
| detached mindfulnessPlease see detailed study description. | Behavioural | DM |
| cognitive restructuringPlease see detailed study description. | Behavioural | CR |
Primary outcome
Y-BOCS Change Score (Pre to Post Assessment)
Time frame: Difference score resulting from (a) first baseline minus post-treatment (non-waitlist) or (b) first baseline minus second baseline (waitlist). In both cases, there are 2 weeks between the two measurements.
German version of the Yale-Brown Obsessive Compulsive Scale (Hand \& Büttner-Westphal, 1991). The mininum value is 0, the maximal value is 40. Higher scores indicate a higher symptom severity of obsessive-compulsive disorder.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18922674Myers SG, Fisher PL, Wells A. An empirical test of the metacognitive model of obsessive-compulsive symptoms: fusion beliefs, beliefs about rituals, and stop signals. J Anxiety Disord. 2009 May;23(4):436-42. doi: 10.1016/j.janxdis.2008.08.007. Epub 2008 Sep 3.
- Background: PubMed 19203749Solem S, Haland AT, Vogel PA, Hansen B, Wells A. Change in metacognitions predicts outcome in obsessive-compulsive disorder patients undergoing treatment with exposure and response prevention. Behav Res Ther. 2009 Apr;47(4):301-7. doi: 10.1016/j.brat.2009.01.003. Epub 2009 Jan 17.
- Background: PubMed 17590836Gonner S, Leonhart R, Ecker W. [The German version of the obsessive-compulsive inventory-revised: a brief self-report measure for the multidimensional assessment of obsessive-compulsive symptoms]. Psychother Psychosom Med Psychol. 2007 Sep-Oct;57(9-10):395-404. doi: 10.1055/s-2007-970894. German.
- BackgroundBaer L. Alles unter Kontrolle: Zwangsgedanken und Zwangshandlungen überwinden. Bern: Hans Huber, 1993.
- BackgroundErtle A, Wahl K, Bohne A, Moritz S, Kordon A, Schulte D. Dimensionen zwangsspezifischer Einstellungen: Der Obsessive-Beliefs Questionnaire (OBQ) für den deutschen Sprachraum analysiert. Zeitschrift für Klinische Psychologie und Psychotherapie 37: 263-271, 2008.
- BackgroundHand I, Büttner-Westphal H. Die Yale-Brown Obsessive Compulsive Scale (Y-BOCS): Ein halbstrukturiertes Interview zur Beurteilung des Schweregrades von Denk- und Handlungszwängen. Verhaltenstherapie 1: 223-225, 1991.
- BackgroundWells A, Gwilliam P, Cartwright-Hatton S. Thought-Fusion-Instrument (TFI, unpublished manuscript). University of Manchester, UK, 2002.
- BackgroundSchulte D. Messung der Therapieerwartung und Therapieevaluation von Patienten (PATHEV). Zeitschrift für Klinische Psychologie und Psychotherapie 34(3): 176-187, 2005.
- BackgroundHautzinger M, Keller F, Kühner C. BDI II. Beck Depressions Inventar. Revision. Frankfurt/Main: Harcourt Test Service, 2006.
- BackgroundWells A, McNicol K. Beliefs About Rituals Inventory (BARI, unpublished manuscript). University of Manchester, UK, 2004.
- BackgroundWells A. Metacognitive therapy for anxiety and depression. Guilford press, 2011.
- BackgroundWilhelm S, Steketee GS. Cognitive therapy for obsessive compulsive disorder: A guide for professionals. New Harbinger Publications, 2006.
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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.
Ulrike Buhlmann, Prof. Dr. principal investigator
Universität Münster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing detached mindfulness and cognitive restructuring in people with Obsessive-Compulsive Disorder, run by Christoph-Dornier-Stiftung für Klinische Psychologie 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 10 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 16 Apr 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 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. 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 16 Apr 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?
Y-BOCS Change Score (Pre to Post Assessment) (time frame: Difference score resulting from (a) first baseline minus post-treatment (non-waitlist) or (b) first baseline minus second baseline (waitlist). In both cases, there are 2 weeks between the two measurements.). 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 NCT03002753, which also lists 23 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 16 Apr 2019.