PsychosisNCT04711460

Mindfulness, Group Therapy and Psychosis; Training Decreases Anxiety and Depression

An observational study of Psychosis, run by University of Minnesota.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of this non-randomized, within-group comparison was to evaluate the addition of mindfulness as a new technique in an outpatient group therapy program for participants diagnosed with a psychotic spectrum disorder, alongside of cognitive behavioral therapy. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Psychosis
What is being tested?: Younger participants, Older participants and TAU
Type of treatment: Lifestyle or therapy programme
How many people: 116 participants
Where: No sites listed yet
Study dates: 1 Jan 2017to 30 Aug 2019
Phase: Observational
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 to 60 years
All sexes
Adult

Study population: . Eligible participants had a DSM-5 diagnosis which included: 295.2 Schizophrenia, Catatonia type, 295.3 Schizophrenia, Paranoid Type, 295.4 Schizophreniform Disorder, 295.70 Schizoaffective Disorder, Depressed Type or Bipolar Type, 295.9 Schizophrenia, Unspecified, 296.34 Major Depressive Disorder, With Psychotic Features, 296.54 Bipolar Disorder, With Psychotic Features, 297.1 Delusional Disorder, 298.8 Brief Psychotic Disorder, 298.9 Unspecified Schizophrenia and Other Psychotic Disorders, 301.22 Schizotypal Personality Disorder.

Who may be able to join

All Diagnostic Statistical Manual, Fifth edition, (DSM-5) diagnoses that included a psychosis spectrum disorder

Who cannot join

those lacking symptoms of psychosis

About this study

Official title: Mindfulness, Group Therapy and Psychosis; Training Decreases Anxiety and Depression in Outpatients With a Psychotic Disorder in a Non-Randomized Within Group Comparison

Read the detailed description

Participants completed the Patient Health Questionnaire-9 (PHQ-9), and the Generalized Anxiety Disorder 7-item scale (GAD-7), at admission and discharge. The first experiment compared scores of those who received mindfulness training plus standard psychiatric treatment or treatment as usual (TAU) against those who received TAU. The second experiment compared age using matched scores from participants who received mindfulness training plus TAU. Participants attended group therapy for a five-week minimum, and were taught the mindfulness practices of breath, acceptance, observation, remaining non-judgmental, and letting go.

Conditions: Psychosis
Being tested: Younger participants, Older participants, TAU, TAU + MIndfulness practice
Keywords: mindfulness, group therapy
Medical subject headings: Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Younger participantsBehavioural
Younger Participants 19-29 years received TAU + Tx over 5 weeks
Older participantsBehavioural
older participants 30-54 years received TAU + Tx over 5 weeks
TAUBehavioural
Participants received TAU or Treatment As Ususal, Cognitive Behavior Therapy only
TAU + MIndfulness practiceBehavioural
Participants received TAU + mindfulness training

Study groups in NCT04711460
Study group	Role	What they receive
Younger participants		Participants were adults ages19 to 29 years who recieved CBT and 10 minutes of Mindfulness Training and practice in group therapy. Receives: Behavioral: Younger participants
Older participants		Participants were adults ages 30-54 years who received CBT and 10 minutes of Mindfulness Training and practice in group therapy. Receives: Behavioral: Older participants
Treatment As Usual (TAU)		. Participants in the "Treatment As Usual" (TAU) group had Cognitive Behavioral Therapy and education about the mindfulness process, but no practice of the mindfulness technique as a group. Receives: Behavioral: TAU
TAU plus mindfulness practice		Participants in the TAU plus Mindfulness Practice had Cognitive Behavioral Therapy (CBT) and 10 minutes of mindfulness practice in group therapy sessions. Receives: Behavioral: TAU + MIndfulness practice

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Generalized Anxiety Disorder-7 Pre/Post Test at Week 5
The Generalized Anxiety Disorder 7-item scale (GAD-7) is a 7-item survey of how often patients are bothered by symptoms of anxiety. Items are rated from 0 (not at all) to 3 (nearly every day). The total score is a sum of item scores and ranges from 0 (minimal depression) to 27 (severe depression). Outcome is reported as the change from baseline to approximately 5 weeks.
Pre / Post-test scores were compared.
Measured: Five weeks
Change in Patient Health Questionnaire-9 Score From Pre / Post-test at Week 5
The Patient Health Questionnaire (PHQ-9) is a 9-item survey of how often patients are bothered by symptoms of depression. Items are rated from 0 (not at all) to 3 (nearly every day). The total score is a sum of item scores and ranges from 0 (minimal depression) to 27 (severe depression). Outcome is reported as the change from baseline to approximately 5 weeks.
Measured: Five weeks

Secondary outcomes (2)

CAGE-Adapted to Include Drug Use (CAGE-AID)
The Cut-Annoyed-Guilty-Eye (CAGE) adapted to include drug use (CAGE-AID) is a screening tool to assess drug use. Participants are asked to answer yes (score of 1) or no (score of 0) to 4 questions about their drug use. Scores range from 0 to 4 with higher scores indicating greater substance use disorder. A score of 2 or higher indicates a problem with alcohol or drugs and is clinically significant. Outcome is reported as the number of participants who scored 2 or lower.
Measured: baseline only
The Columbia Suicide Severity Rating Scale (C-SSRS)
The Columbia Suicide Severity Rating Scale, or C-SSRS, measures four constructs: the severity of ideation, the intensity of ideation, behavior, and lethality. Items are rated on a scale from 0-4: Eligible participants scored at 2 or lower.
1. Only one time
2. A few times
3. A lot
4. All the time
5. Don't know/Not applicable
The Columbia was done prior to being considered for the Outpatient Mental Health program by another licensed mental health staff in another department. Only those who scored at 1-2 would be considered for Outpatient. Outcome is reported as the number of participants who score a one or two on the scale, which means they are considered safe to participate.
Measured: baseline only

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201730 Aug 2019

First posted15 Jan 2021
Study start1 Jan 2017
Primary completion30 Aug 2019
Study completion30 Aug 2019

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 PsychosisStudies of the same condition, open and under way.
More trials run by University of MinnesotaThe 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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04711460
Sponsor's protocol ID: STUDY00005035
Status last verified: May 2023
First submitted: 15 Dec 2020
Last updated: 2 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data is not available for sharing

Publications

Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
PubMed 12703651
Brown RL, Rounds LA. Conjoint screening questionnaires for alcohol and other drug abuse: criterion validity in a primary care practice. Wis Med J. 1995;94(3):135-40.
PubMed 7778330
Chadwick P, Hughes S, Russell D, Russell I, Dagnan D. Mindfulness groups for distressing voices and paranoia: a replication and randomized feasibility trial. Behav Cogn Psychother. 2009 Jul;37(4):403-12. doi: 10.1017/S1352465809990166. Epub 2009 Jun 23.
PubMed 19545481
Chadwick P. Mindfulness for psychosis. Br J Psychiatry. 2014;204:333-4. doi: 10.1192/bjp.bp.113.136044.
PubMed 24785766
Chadwick P, Strauss C, Jones AM, Kingdon D, Ellett L, Dannahy L, Hayward M. Group mindfulness-based intervention for distressing voices: A pragmatic randomised controlled trial. Schizophr Res. 2016 Aug;175(1-3):168-173. doi: 10.1016/j.schres.2016.04.001. Epub 2016 Apr 14.
PubMed 27146475
Chadwick P. Mindfulness for psychosis: a humanising therapeutic process. Curr Opin Psychol. 2019 Aug;28:317-320. doi: 10.1016/j.copsyc.2019.07.022. Epub 2019 Jul 18.
PubMed 31382104
Chien WT, Thompson DR. Effects of a mindfulness-based psychoeducation programme for Chinese patients with schizophrenia: 2-year follow-up. Br J Psychiatry. 2014 Jul;205(1):52-9. doi: 10.1192/bjp.bp.113.134635. Epub 2014 May 8.
PubMed 24809397
Dhalla S, Kopec JA. The CAGE questionnaire for alcohol misuse: a review of reliability and validity studies. Clin Invest Med. 2007;30(1):33-41. doi: 10.25011/cim.v30i1.447.
PubMed 17716538
Dixon LB, Holoshitz Y, Nossel I. Treatment engagement of individuals experiencing mental illness: review and update. World Psychiatry. 2016 Feb;15(1):13-20. doi: 10.1002/wps.20306.
PubMed 26833597
Ellett L. Mindfulness for paranoid beliefs: evidence from two case studies. Behav Cogn Psychother. 2013 Mar;41(2):238-42. doi: 10.1017/S1352465812000586. Epub 2012 Sep 14.
PubMed 22974494
Hayes SC. Acceptance and Commitment Therapy, Relational Frame Theory, and the Third Wave of Behavioral and Cognitive Therapies - Republished Article. Behav Ther. 2016 Nov;47(6):869-885. doi: 10.1016/j.beth.2016.11.006. Epub 2016 Nov 10.
PubMed 27993338
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941
Khoury B, Lecomte T, Gaudiano BA, Paquin K. Mindfulness interventions for psychosis: a meta-analysis. Schizophr Res. 2013 Oct;150(1):176-84. doi: 10.1016/j.schres.2013.07.055. Epub 2013 Aug 15.
PubMed 23954146
Langer AI, Cangas AJ, Salcedo E, Fuentes B. Applying mindfulness therapy in a group of psychotic individuals: a controlled study. Behav Cogn Psychother. 2012 Jan;40(1):105-9. doi: 10.1017/S1352465811000464. Epub 2011 Sep 9.
PubMed 21902854
Morrison AP, Wells A. A comparison of metacognitions in patients with hallucinations, delusions, panic disorder, and non-patient controls. Behav Res Ther. 2003 Feb;41(2):251-6. doi: 10.1016/s0005-7967(02)00095-5.
PubMed 12547384

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Psychosis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mindfulness, Group Therapy and Psychosis; Training Decreases Anxiety and Depression in Outpatients With a Psychotic Disorder in a Non-Randomized Within Group Comparison
ClinicalTrials.gov ID: NCT04711460
Acronym / sponsor ID: STUDY00005035
Conditions: Psychosis
Keywords: mindfulness, group therapy
Study type: Observational
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: 1 Jan 2017 (actual)
Primary completion: 30 Aug 2019 (actual)
Study completion: 30 Aug 2019 (actual)
First posted: 15 Jan 2021 (actual)
Results: Posted 2 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 4

Arm	Type	Receives
Younger participants	–	Behavioral: Younger participantsParticipants were adults ages19 to 29 years who recieved CBT and 10 minutes of Mindfulness Training and practice in group therapy.
Older participants	–	Behavioral: Older participantsParticipants were adults ages 30-54 years who received CBT and 10 minutes of Mindfulness Training and practice in group therapy.
Treatment As Usual (TAU)	–	Behavioral: TAU. Participants in the "Treatment As Usual" (TAU) group had Cognitive Behavioral Therapy and education about the mindfulness process, but no practice of the mindfulness technique as a group.
TAU plus mindfulness practice	–	Behavioral: TAU + MIndfulness practiceParticipants in the TAU plus Mindfulness Practice had Cognitive Behavioral Therapy (CBT) and 10 minutes of mindfulness practice in group therapy sessions.

Who may qualify

Ages: 18 to 60 years
Sex: All
Age groups: Adult
Study population: . Eligible participants had a DSM-5 diagnosis which included: 295.2 Schizophrenia, Catatonia type, 295.3 Schizophrenia, Paranoid Type, 295.4 Schizophreniform Disorder, 295.70 Schizoaffective Disorder, Depressed Type or Bipolar Type, 295.9 Schizophrenia, Unspecified, 296.34 Major Depressive Disorder, With Psychotic Features, 296.54 Bipolar Disorder, With Psychotic Features, 297.1 Delusional Disorder, 298.8 Brief Psychotic Disorder, 298.9 Unspecified Schizophrenia and Other Psychotic Disorders, 301.22 Schizotypal Personality Disorder.

Key inclusion criteria (1 listed)

All Diagnostic Statistical Manual, Fifth edition, (DSM-5) diagnoses that included a psychosis spectrum disorder

Key exclusion criteria (1 listed)

those lacking symptoms of psychosis

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
Younger participantsYounger Participants 19-29 years received TAU + Tx over 5 weeks	Behavioural	Younger participants
Older participantsolder participants 30-54 years received TAU + Tx over 5 weeks	Behavioural	Older participants
TAUParticipants received TAU or Treatment As Ususal, Cognitive Behavior Therapy only	Behavioural	Treatment As Usual (TAU)
TAU + MIndfulness practiceParticipants received TAU + mindfulness training	Behavioural	TAU plus mindfulness practice

Primary outcome

Change in Generalized Anxiety Disorder-7 Pre/Post Test at Week 5
Time frame: Five weeks
The Generalized Anxiety Disorder 7-item scale (GAD-7) is a 7-item survey of how often patients are bothered by symptoms of anxiety. Items are rated from 0 (not at all) to 3 (nearly every day). The total score is a sum of item scores and ranges from 0 (minimal depression) to 27 (severe depression). Outcome is reported as the change from baseline to approximately 5 weeks. Pre / Post-test scores were compared.
Change in Patient Health Questionnaire-9 Score From Pre / Post-test at Week 5
Time frame: Five weeks
The Patient Health Questionnaire (PHQ-9) is a 9-item survey of how often patients are bothered by symptoms of depression. Items are rated from 0 (not at all) to 3 (nearly every day). The total score is a sum of item scores and ranges from 0 (minimal depression) to 27 (severe depression). Outcome is reported as the change from baseline to approximately 5 weeks.

2 secondary outcomes

CAGE-Adapted to Include Drug Use (CAGE-AID)
Time frame: baseline only
The Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: baseline only

Results and safety

Results posted to the registry on 2 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1: TAU	32	32
The TAU + Treatment Group	32	32
Younger Participants	26	26
Older Participants	26	26

Primary outcome: Change in Generalized Anxiety Disorder-7 Pre/Post Test at Week 5

Time frame: Five weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Treatment as Usual n = 32	TAU + Mindfulness Training n = 32	Younger Participants n = 26	Older Participants n = 26
Value	4.68 (5.4)	6.28 (5.59)	3.96 (5.39)	7.38 (5.13)

Treatment as Usual vs TAU + Mindfulness Training: Mean Difference (Final Values): 0.003, p = 0.003, t-test, 2 sided
Treatment as Usual vs TAU + Mindfulness Training: Mean Difference (Final Values): 0.009, p = 0.009, ANOVA
Treatment as Usual vs TAU + Mindfulness Training: Mean Difference (Final Values): 0.05, p <0.05, Tukey Kramer Post-Hoc

Population analysed: The Generalized Anxiety Disorder 7 number of participants for two studies: Treatment as usual vs TAU + Mindfulness study and the Younger versus older study.

Primary outcome: Change in Patient Health Questionnaire-9 Score From Pre / Post-test at Week 5

Time frame: Five weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Treatment as Usual n = 32	TAU + Mindfulness Training n = 32	Younger Participants n = 26	Older Participants n = 26
Value	6.68 (6.4)	6.96 (7.19)	3.96 (5.39)	7.38 (5.13)

Treatment as Usual vs TAU + Mindfulness Training: Mean Difference (Final Values): 0.05, p = 0.002, t-test, 2 sided
Treatment as Usual vs TAU + Mindfulness Training: Mean Difference (Final Values): 0.05, p = 0.054, ANOVA
Younger Participants vs Older Participants: Mean Difference (Final Values): 0.05, p = 0.019, t-test, 2 sided

Population analysed: The Patient Health Questionnaire-9 scale number of participants in each study: The Treatment as usual (TAU) versus TAU + Mindfulness and the Younger versus Older study.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data was collected over two years to obtain results for the groups.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1: The TAU Group / TAU vs TAU + TX	0 of 32 (0%)	0 of 32 (0%)	0 of 32
The TAU + TX Group / TAU vs TAU + TX	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Younger Participants / Younger vs Older Scores	0 of 26 (0%)	0 of 26 (0%)	0 of 26
Older Participants / Younger vs Older Scores	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Limitations and caveats (from the sponsor): Limitations and caveats include the sample size. If a larger data base was collected, more significant results may have occurred. Data collection assumes that all participants will answer honestly on both scales. The financial resources and equipment were limited to what the author provided, as there were no grants. The setting was a group room, and some participants may prefer to be outside or be alone.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12703651Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
Background: PubMed 7778330Brown RL, Rounds LA. Conjoint screening questionnaires for alcohol and other drug abuse: criterion validity in a primary care practice. Wis Med J. 1995;94(3):135-40.
Background: PubMed 19545481Chadwick P, Hughes S, Russell D, Russell I, Dagnan D. Mindfulness groups for distressing voices and paranoia: a replication and randomized feasibility trial. Behav Cogn Psychother. 2009 Jul;37(4):403-12. doi: 10.1017/S1352465809990166. Epub 2009 Jun 23.
Background: PubMed 24785766Chadwick P. Mindfulness for psychosis. Br J Psychiatry. 2014;204:333-4. doi: 10.1192/bjp.bp.113.136044.
Background: PubMed 27146475Chadwick P, Strauss C, Jones AM, Kingdon D, Ellett L, Dannahy L, Hayward M. Group mindfulness-based intervention for distressing voices: A pragmatic randomised controlled trial. Schizophr Res. 2016 Aug;175(1-3):168-173. doi: 10.1016/j.schres.2016.04.001. Epub 2016 Apr 14.
Background: PubMed 31382104Chadwick P. Mindfulness for psychosis: a humanising therapeutic process. Curr Opin Psychol. 2019 Aug;28:317-320. doi: 10.1016/j.copsyc.2019.07.022. Epub 2019 Jul 18.
Background: PubMed 24809397Chien WT, Thompson DR. Effects of a mindfulness-based psychoeducation programme for Chinese patients with schizophrenia: 2-year follow-up. Br J Psychiatry. 2014 Jul;205(1):52-9. doi: 10.1192/bjp.bp.113.134635. Epub 2014 May 8.
Background: PubMed 17716538Dhalla S, Kopec JA. The CAGE questionnaire for alcohol misuse: a review of reliability and validity studies. Clin Invest Med. 2007;30(1):33-41. doi: 10.25011/cim.v30i1.447.
Background: PubMed 26833597Dixon LB, Holoshitz Y, Nossel I. Treatment engagement of individuals experiencing mental illness: review and update. World Psychiatry. 2016 Feb;15(1):13-20. doi: 10.1002/wps.20306.
Background: PubMed 22974494Ellett L. Mindfulness for paranoid beliefs: evidence from two case studies. Behav Cogn Psychother. 2013 Mar;41(2):238-42. doi: 10.1017/S1352465812000586. Epub 2012 Sep 14.
Background: PubMed 27993338Hayes SC. Acceptance and Commitment Therapy, Relational Frame Theory, and the Third Wave of Behavioral and Cognitive Therapies - Republished Article. Behav Ther. 2016 Nov;47(6):869-885. doi: 10.1016/j.beth.2016.11.006. Epub 2016 Nov 10.
Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Individual participant dataSharing planned: No. Data is not available for sharing

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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 D Lund, Psy.D. principal investigator

University of Minnesota

Questions about this trial

What is this clinical trial studying?

An observational study of Psychosis, run by University of Minnesota.

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 1 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 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Feb 2024). 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 Generalized Anxiety Disorder-7 Pre/Post Test at Week 5 (time frame: Five weeks). 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 NCT04711460, 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 2 Feb 2024.