Posttraumatic Stress DisorderNCT04109196
Examining Changes in Microbiota Over the Course of PTSD Treatment
A study testing Cognitive Processing Therapy in people with Posttraumatic Stress Disorder and Depression, run by Rush University Medical Center at 1 site in United States.
Trial summary
The overall goals of this project are to evaluate the use of 5-day intensively-delivered Cognitive Processing Therapy to treat PTSD and to determine the associations between the microbiome, salivary cytokines, and the presence of and recovery from PTSD. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Posttraumatic Stress Disorder, Depression
- What is being tested?
- Cognitive Processing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 9 Apr 2021
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals are eligible for the study if they:
- Are 18 years or older
- Are fluent in English
- Have experienced a Criterion A traumatic event during their lifetime
- Have a PTSD diagnosis verified by the Clinician Administered PTSD Scale for DSM-5
- Are interested in receiving evidence-based treatment (CPT) for PTSD and able to attend 10 therapy sessions over the course of one week (5 days)
- Are willing and interested to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study
Who cannot join
- Individuals are excluded from the study if:
- The traumatic event occurred in the past month
- They are currently suicidal or homicidal, as indicated by a positive screen on the C-SSRS Question 4 or Question 5 at intake.
- They have a history of psychosis or mania
- They have not been on a stable dose of medication for at least one month
- They have dietary patterns not representative of normal populations (e.g., vegetarian, vegan, gluten-free)
Show all 18Show fewer
- They made changes to the diet in the past month or are planning to make changes over the course of therapy
- They have completed an evidence-based PTSD treatment in the past 3 months or are currently receiving an evidence-based PTSD treatment
- They have mental retardation or significant cognitive impairment that would prevent them from engaging in CPT
- They have a serious or unstable medical illness or instability for which hospitalization may be likely within the next year
- They have an active substance use disorder (within the past 3 months)
- They are involved with current legal actions related to the traumatic event that is anticipated to be targeted during treatment
- They have a history or presence of an eating disorder
- They are currently taking or have taken an antibiotic in the past 30 days
- They are currently taking a corticosteroid
- They have had part of the digestive tract removed or altered
- They have had any surgery or procedure within the past 30 days that has required fasting for more than 12 hours or bowel preparation beforehand
- They are unwilling to provide fecal and saliva samples (applies to trauma-exposed control condition only)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
The overall goals of this project are to evaluate the use of 5-day intensively-delivered Cognitive Processing Therapy to treat PTSD and to determine the associations between the microbiome, salivary cytokines, and the presence of and recovery from PTSD. Specifically, this study is designed to 1) determine whether individual Cognitive Processing Therapy (CPT) delivered twice per day over 5 consecutive days (CPT-5) is tolerable, acceptable, and effective in reducing PTSD symptoms, 2) determine the microbial signatures associated with PTSD, 3) evaluate whether the abundance and composition of microbiota and salivary cytokine levels change over the course of PTSD treatment, and 4) examine whether changes in microbial signatures are associated with changes in cytokine levels.
Read the detailed description
This project will evaluate the use of 5-day intensively-delivered Cognitive Processing Therapy to treat PTSD and will aim to determine the associations between the microbiome, salivary cytokines, and the presence of and recovery from PTSD. A total of 24 participants who have experienced a criterion A trauma will be recruited. An intake assessment will be used to confirm the fit for the proposed project. Clinical interviewers with a minimum of a Master's degree in Psychology who are not providing the treatment will administer structured diagnostic interviews (CAPS and DIAMOND). If an individual meets criteria for a PTSD diagnosis based on the CAPS they will be eligible for this treatment study.
Study staff will administer brief computerized assessments (e.g. Stroop task), a full self-report assessment battery, and two internet-based dietary assessments to all participants. Study staff will also collect fecal- and oral-derived microbiota and salivary cytokine samples from individuals who opt in to this aspect of the study.
Study Treatment - Intensive Week-Long Cognitive Processing Therapy (CPT):
The individuals in this study will undergo a course of 1-week-long Cognitive Processing Therapy (CPT-5). CPT-5 will be delivered twice per day over the course of five business days. Each 50 minute session will closely follow the CPT protocol and will be conducted by either Dr. Held, other doctoral-level psychologists, postdoctoral fellows, or other Master's level (or higher) clinicians who have received the official two-day CPT training and who are not involved in study assessments. CPT worksheets and homework assignments may be collected and copied for research purposes. Changes in PTSD severity and other relevant symptoms will be assessed before, during, and after the course of CPT using well-validated clinician-administered, self-report, and computerized assessments. Fecal- and oral-derived microbiota as well as salivary cytokines will also be assessed at various pre-treatment, post-treatment, and follow-up time points to determine whether the microbiome and cytokine levels change over the course of CPT. Participants in this study will have the option to opt out of providing these biological samples and still receive CPT-5.
Semi-Structured Interview:
Regardless of whether they completed the course of CPT, participants in the study may be asked to participate in one 20-40 minute semi-structured interview. The interviewer, who is a member of the research team and not the respective participant's study therapist, will ask general questions about the participant's experiences of CPT-5 and gather information about the participant's perceptions of the tolerability, acceptability, and feasibility of the intervention.
- Conditions
- Posttraumatic Stress Disorder, Depression
- Being tested
- Cognitive Processing Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing TherapyBehavioural
Cognitive Processing Therapy is an evidence-based treatment for PTSD that will be delivered intensively twice per day over the course of five days.
| Study group | Role | What they receive |
|---|---|---|
| Intensive 5-day Cognitive Processing Therapy for PTSD | Experimental | Participants who are eligible for and enrolled in the study will receive a 5-day CPT treatment for PTSD. All participants will be asked to complete clinician-rated and self-report assessments at multiple time points during the study. Participants will also be asked to provide fecal and saliva samples as part of the study, however, they may opt out of biological sample collection. Receives: Behavioral: Cognitive Processing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL-5)
This will be used to assess severity of posttraumatic stress disorder symptoms at intake.The PTSD Checklist for DSM-5 (PCL-5) measures severity of PTSD symptoms. This questionnaire includes 20 items, which each item rated on a scale of 0 (not at all)-4 (extremely). There are four subscales reflecting symptom clusters in the DSM-5: intrusion (five items), avoidance (two items), negative alterations in cognitions and mood (seven items), and alterations in arousal and reactivity (six items). All 20 items are summed to calculate a total score. Scores range from 0-80, with higher scores indicating more severe symptoms.
Measured: Baseline
Change in PTSD Checklist for DSM-5 (PCL-5) From Baseline
This will be used to assess changes in posttraumatic stress disorder symptom severity from baseline to the time points described below and/or changes between the time points described below. The PTSD Checklist for DSM-5 (PCL-5) measures severity of PTSD symptoms. This questionnaire includes 20 items, which each item rated on a scale of 0 (not at all)-4 (extremely). There are four subscales reflecting symptom clusters in the DSM-5: intrusion (five items), avoidance (two items), negative alterations in cognitions and mood (seven items), and alterations in arousal and reactivity (six items). All 20 items are summed to calculate a total score. Scores range from 0-80, with higher scores indicating more severe symptoms.
Measured: 1 week post-treatment, 3 months post treatment
Patient Health Questionnaire-9 (PHQ-9)
This will be used to assess severity of depression symptoms at intake. The Patient Health Quetionnaire-9 (PHQ-9) measures severity of depression symptoms. This questionnaire includes 10 items, with each item rated on a scale of 0 (not at all)-3 (nearly every day). The first 9 items are summed to calculate a total score. Scores range from 0-27, with higher scores indicating more severe symptoms. The tenth item (also rated 0-3) is not included in the total score, but indicates how much interference the responder experiences in their day to day life due to symptoms they are experiencing.
Measured: Baseline
Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline
This will be used to assess changes in depression symptom severity from baseline to the time points described below and/or changes between the time points described below. This will be used to assess severity of depression symptoms at intake. The Patient Health Quetionnaire-9 (PHQ-9) measures severity of depression symptoms. This questionnaire includes 10 items, with each item rated on a scale of 0 (not at all)-3 (nearly every day). The first 9 items are summed to calculate a total score. Scores range from 0-27, with higher scores indicating more severe symptoms. The tenth item (also rated 0-3) is not included in the total score, but indicates how much interference the responder experiences in their day to day life due to symptoms they are experiencing.
Measured: 1 week post-treatment, 3 months post-treatment
Change in DNA Genotek OMNIgeneGUT for Microbiome Kit (OMR-200) From Baseline
Change in microbial signature (abundance and composition) from colonic fecal sample from baseline to the time points described below and/or changes between the time points described below.
Measured: Intake, Day 1 of treatment, 1 week post-treatment, 3 months post-treatment
DNA Genotek OMNIgeneORAL for Collection of Microbial DNA Kit (OM-501)
Microbial signature (abundance and composition) from oral saliva sample collected at intake.
Measured: Baseline
Change in DNA Genotek OMNIgeneORAL for Collection of Microbial DNA Kit (OM-501) From Baseline
Change in microbial signature (abundance and composition) from oral saliva sample from baseline to the time points described below and/or changes between the time points described below.
Measured: Intake, Day 1 of treatment, 1 week post-treatment, 3 months post-treatment
Salimetrics Salivary Cytokine Panel
Salivary cytokine levels (TNF-alpha, IL-1beta, IL-6, IL-8) from oral saliva sample collected at intake.
Measured: Baseline
Change in Salimetrics Salivary Cytokine Panel From Baseline
Change in salivary cytokine levels (TNF-alpha, IL-1beta, IL-6, IL-8) from baseline to the time points described below and/or changes between the time points described below.
Measured: Intake, Day 1 of treatment, 1 week post-treatment, 3 months post-treatment
Secondary outcomes (2)
Posttraumatic Cognitions Inventory (PTCI)
Will be used to assess intensity of negative posttrauma cognitions at intake. The PTCI score is calculated by summing all items, with scores ranging from 22 to 231. Higher scores indicate more severe negative cognitions.
Measured: Baseline
Change in Posttraumatic Cognitions Inventory (PTCI) From Baseline
Will be used to assess changes in intensity of negative posttrauma cognitions from baseline to the time points described below and/or changes between the time points described below. The PTCI score is calculated by summing all items, with scores ranging from 22 to 231. Higher scores indicate more severe negative cognitions.
Measured: 1 week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Oct 2019
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
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.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants who are eligible for this study will receive a 5 day PTSD treatment.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Chicago, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Philip Held, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109196
- Sponsor's protocol ID
- 18011005
- Other IDs
- 5KL2TR002387-02
- Status last verified
- Jun 2023
- First submitted
- 6 Sep 2019
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Changes in Microbiota Over the Course of PTSD Treatment
- ClinicalTrials.gov ID
- NCT04109196
- Acronym / sponsor ID
- 18011005
- Conditions
- Posttraumatic Stress Disorder, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), University of Chicago, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 9 Apr 2021 (actual)
- Study completion
- 9 Apr 2021 (actual)
- First posted
- 30 Sep 2019 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goals of this project are to evaluate the use of 5-day intensively-delivered Cognitive Processing Therapy to treat PTSD and to determine the associations between the microbiome, salivary cytokines, and the presence of and recovery from PTSD. Specifically, this study is designed to 1) determine whether individual Cognitive Processing Therapy (CPT) delivered twice per day over 5 consecutive days (CPT-5) is tolerable, acceptable, and effective in reducing PTSD symptoms, 2) determine the microbial signatures associated with PTSD, 3) evaluate whether the abundance and composition of microbiota and salivary cytokine levels change over the course of PTSD treatment, and 4) examine whether changes in microbial signatures are associated with changes in cytokine levels.
Detailed description
This project will evaluate the use of 5-day intensively-delivered Cognitive Processing Therapy to treat PTSD and will aim to determine the associations between the microbiome, salivary cytokines, and the presence of and recovery from PTSD. A total of 24 participants who have experienced a criterion A trauma will be recruited. An intake assessment will be used to confirm the fit for the proposed project. Clinical interviewers with a minimum of a Master's degree in Psychology who are not providing the treatment will administer structured diagnostic interviews (CAPS and DIAMOND). If an individual meets criteria for a PTSD diagnosis based on the CAPS they will be eligible for this treatment study.
Study staff will administer brief computerized assessments (e.g. Stroop task), a full self-report assessment battery, and two internet-based dietary assessments to all participants. Study staff will also collect fecal- and oral-derived microbiota and salivary cytokine samples from individuals who opt in to this aspect of the study.
Study Treatment - Intensive Week-Long Cognitive Processing Therapy (CPT):
The individuals in this study will undergo a course of 1-week-long Cognitive Processing Therapy (CPT-5). CPT-5 will be delivered twice per day over the course of five business days. Each 50 minute session will closely follow the CPT protocol and will be conducted by either Dr. Held, other doctoral-level psychologists, postdoctoral fellows, or other Master's level (or higher) clinicians who have received the official two-day CPT training and who are not involved in study assessments. CPT worksheets and homework assignments may be collected and copied for research purposes. Changes in PTSD severity and other relevant symptoms will be assessed before, during, and after the course of CPT using well-validated clinician-administered, self-report, and computerized assessments. Fecal- and oral-derived microbiota as well as salivary cytokines will also be assessed at various pre-treatment, post-treatment, and follow-up time points to determine whether the microbiome and cytokine levels change over the course of CPT. Participants in this study will have the option to opt out of providing these biological samples and still receive CPT-5.
Semi-Structured Interview:
Regardless of whether they completed the course of CPT, participants in the study may be asked to participate in one 20-40 minute semi-structured interview. The interviewer, who is a member of the research team and not the respective participant's study therapist, will ask general questions about the participant's experiences of CPT-5 and gather information about the participant's perceptions of the tolerability, acceptability, and feasibility of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants who are eligible for this study will receive a 5 day PTSD treatment.
| Arm | Type | Receives |
|---|---|---|
| Intensive 5-day Cognitive Processing Therapy for PTSD | Experimental | Behavioral: Cognitive Processing TherapyParticipants who are eligible for and enrolled in the study will receive a 5-day CPT treatment for PTSD. All participants will be asked to complete clinician-rated and self-report assessments at multiple time points during the study. Participants will also be asked to provide fecal and saliva samples as part of the study, however, they may opt out of biological sample collection. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are 18 years or older
- Are fluent in English
- Have experienced a Criterion A traumatic event during their lifetime
- Have a PTSD diagnosis verified by the Clinician Administered PTSD Scale for DSM-5
- Are interested in receiving evidence-based treatment (CPT) for PTSD and able to attend 10 therapy sessions over the course of one week (5 days)
Key exclusion criteria (18 listed)
- The traumatic event occurred in the past month
- They are currently suicidal or homicidal, as indicated by a positive screen on the C-SSRS Question 4 or Question 5 at intake.
- They have a history of psychosis or mania
- They have not been on a stable dose of medication for at least one month
- They have dietary patterns not representative of normal populations (e.g., vegetarian, vegan, gluten-free)
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 |
|---|---|---|
| Cognitive Processing TherapyCognitive Processing Therapy is an evidence-based treatment for PTSD that will be delivered intensively twice per day over the course of five days. | Behavioural | Intensive 5-day Cognitive Processing Therapy for PTSD |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5)
Time frame: Baseline
This will be used to assess severity of posttraumatic stress disorder symptoms at intake.The PTSD Checklist for DSM-5 (PCL-5) measures severity of PTSD symptoms. This questionnaire includes 20 items, which each item rated on a scale of 0 (not at all)-4 (extremely). There are four subscales reflecting symptom clusters in the DSM-5: intrusion (five items), avoidance (two items), negative alterations in cognitions and mood (seven items), and alterations in arousal and reactivity (six items). All 20 items are summed to calculate a total score. Scores range from 0-80, with higher scores indicating more severe symptoms.
Change in PTSD Checklist for DSM-5 (PCL-5) From Baseline
Time frame: 1 week post-treatment, 3 months post treatment
This will be used to assess changes in posttraumatic stress disorder symptom severity from baseline to the time points described below and/or changes between the time points described below. The PTSD Checklist for DSM-5 (PCL-5) measures severity of PTSD symptoms. This questionnaire includes 20 items, which each item rated on a scale of 0 (not at all)-4 (extremely). There are four subscales reflecting symptom clusters in the DSM-5: intrusion (five items), avoidance (two items), negative alterations in cognitions and mood (seven items), and alterations in arousal and reactivity (six items). All 20 items are summed to calculate a total score. Scores range from 0-80, with higher scores indicating more severe symptoms.
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline
This will be used to assess severity of depression symptoms at intake. The Patient Health Quetionnaire-9 (PHQ-9) measures severity of depression symptoms. This questionnaire includes 10 items, with each item rated on a scale of 0 (not at all)-3 (nearly every day). The first 9 items are summed to calculate a total score. Scores range from 0-27, with higher scores indicating more severe symptoms. The tenth item (also rated 0-3) is not included in the total score, but indicates how much interference the responder experiences in their day to day life due to symptoms they are experiencing.
Change in Patient Health Questionnaire-9 (PHQ-9) From Baseline
Time frame: 1 week post-treatment, 3 months post-treatment
This will be used to assess changes in depression symptom severity from baseline to the time points described below and/or changes between the time points described below. This will be used to assess severity of depression symptoms at intake. The Patient Health Quetionnaire-9 (PHQ-9) measures severity of depression symptoms. This questionnaire includes 10 items, with each item rated on a scale of 0 (not at all)-3 (nearly every day). The first 9 items are summed to calculate a total score. Scores range from 0-27, with higher scores indicating more severe symptoms. The tenth item (also rated 0-3) is not included in the total score, but indicates how much interference the responder experiences in their day to day life due to symptoms they are experiencing.
Change in DNA Genotek OMNIgeneGUT for Microbiome Kit (OMR-200) From Baseline
Time frame: Intake, Day 1 of treatment, 1 week post-treatment, 3 months post-treatment
Change in microbial signature (abundance and composition) from colonic fecal sample from baseline to the time points described below and/or changes between the time points described below.
DNA Genotek OMNIgeneORAL for Collection of Microbial DNA Kit (OM-501)
Time frame: Baseline
Microbial signature (abundance and composition) from oral saliva sample collected at intake.
Change in DNA Genotek OMNIgeneORAL for Collection of Microbial DNA Kit (OM-501) From Baseline
Time frame: Intake, Day 1 of treatment, 1 week post-treatment, 3 months post-treatment
Change in microbial signature (abundance and composition) from oral saliva sample from baseline to the time points described below and/or changes between the time points described below.
Salimetrics Salivary Cytokine Panel
Time frame: Baseline
Salivary cytokine levels (TNF-alpha, IL-1beta, IL-6, IL-8) from oral saliva sample collected at intake.
Change in Salimetrics Salivary Cytokine Panel From Baseline
Time frame: Intake, Day 1 of treatment, 1 week post-treatment, 3 months post-treatment
Change in salivary cytokine levels (TNF-alpha, IL-1beta, IL-6, IL-8) from baseline to the time points described below and/or changes between the time points described below.
2 secondary outcomes
Posttraumatic Cognitions Inventory (PTCI)
Time frame: Baseline
Change in Posttraumatic Cognitions Inventory (PTCI) From Baseline
Time frame: 1 week post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Processing Therapy in people with Posttraumatic Stress Disorder and Depression, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jun 2023). 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?
PTSD Checklist for DSM-5 (PCL-5) (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2023.