Major Depressive DisorderPhase 1NCT03645096
Development of Pregnenolone as a Treatment for Depression
A Phase 1 study testing Pregnenolone 500 mg and Pregnenolone 800 mg in people with Major Depressive Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Pregnenolone, an over-the-counter supplement, is a naturally occurring neurosteroid made in the adrenal glands and brain. Preclinical research suggests pregnenolone has antidepressant, cognitive enhancing, and neuroprotective properties, particularly in women. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Pregnenolone 500 mg and Pregnenolone 800 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 31 May 2022
- Phase
- Phase 1
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women, ages 18-65 years, with current MDD (mild or moderate severity per DSM-5) based on SCID-CV.
- No psychotropic medications, other than PRN (as needed) hypnotics, within 28 days of randomization (medication free).
- PRN hypnotics allowed up to 3 days prior to study drug administrations but not while receiving study drug.
Who cannot join
- Severe MDD based on DSM-5 severity criteria and/or a baseline HRSD score > 27 (consistent with severe depressive symptom severity).
- High risk for suicide (active SI with plan/intent or > 2 lifetime attempts in lifetime or any in the past 6 months).
- Treatment resistant depression (fail two adequate antidepressant trials or ECT during current episode).
- Vulnerable populations (e.g. pregnant/nursing, severe cognitive or intellectual impairment, incarcerated).
- Coronary artery disease, atrial fibrillation, stroke, deep vein thrombosis, pulmonary embolism or blood clotting disorder, or any severe, life threatening or unstable, medical condition.
- History of allergic reaction or side effects with prior pregnenolone use.
Show all 12Show fewer
- Current substance use disorder defined as meeting criteria for a use disorder based on the SCID interview and self-reported use within the past 3 months, or a positive baseline urine drug screen.
- Current psychotic features (hallucinations, delusions, disorganized thought processes) or eating disorders.
- Anxiety disorders of sufficient severity to be the primary focus of clinical attention (e.g. severe obsessive compulsive or post-traumatic stress disorders).
- Hormone-sensitive conditions (i.e. breast cancer; uterine/ovarian cancer, endometriosis, uterine fibroids).
- Clinically significant laboratory, physical examination, or electrocardiogram (ECG) findings.
- Currently using oral contraceptives containing progestin (barrier methods allowed).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NCCIH Development of Pregnenolone as a Treatment for Depression R61 Phase
Pregnenolone, an over-the-counter supplement, is a naturally occurring neurosteroid made in the adrenal glands and brain. Preclinical research suggests pregnenolone has antidepressant, cognitive enhancing, and neuroprotective properties, particularly in women. The following hypothesis will be tested in this trial: pregnenolone is associated with improvement in depressive symptom severity in women that is associated with changes in the resting state functional connectivity (rsFC) and GABA.
Read the detailed description
In this study, 26 adult women meeting criteria for Major Depressive Disorder (MDD) as defined in DSM 5, will be randomized to a double-blind, placebo-controlled, crossover phase I clinical trial of pregnenolone (i.e. each participant receives 500 mg/d, 800 mg/d pregnenolone and placebo in random order). The study will consist of three 7-day treatment exposures to each pregnenolone dose with a 14-day washout between each exposure. Baseline evaluation will include medical and psychiatric history, psychiatric interview, standard laboratory analyses (i.e., blood draw, ECG), and a brief cognitive battery. Neuroimaging will be collected after each study drug or placebo administration. Study drug tolerability and participant safety will be assessed throughout the study (6 in-clinic visits + a safety visit) using structured clinical interviews, self-report questionnaires, and standard laboratory analyses.
- Conditions
- Major Depressive Disorder
- Being tested
- Pregnenolone 500 mg, Pregnenolone 800 mg, Placebo
- Keywords
- Depression, Pregnenolone, Women
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnenolone 500 mgDrug
Also called Neurosteroid
Pregnenolone 500 mg capsule.
Pregnenolone 800 mgDrug
Also called Neurosteroid
Pregnenolone 800 mg capsule.
PlaceboDrug
Placebo capsule manufactured to mimic pregnenolone capsule.
| Study group | Role | What they receive |
|---|---|---|
| Pregnenolone 500 > Pregnenolone 800 > Placebo | Experimental | 3 exposures in order:
1. Pregnenolone 500 mg capsule by mouth, daily for 7 days followed by 14 day washout.
2. Pregnenolone 800 mg capsule by mouth, daily for 7 days followed by 14 day washout.
3. Matching placebo capsule by mouth, daily for 7 days. Receives: Drug: Pregnenolone 500 mg; Drug: Pregnenolone 800 mg; Drug: Placebo |
| Pregnenolone 500 > Placebo > Pregnenolone 800 | Experimental | 3 exposures in order:
1. Pregnenolone 500 mg capsule by mouth, daily for 7 days followed by 14 day washout.
2. Matching placebo capsule by mouth, daily for 7 days followed by 14 day washout.
3. Pregnenolone 800 mg capsule by mouth, daily for 7 days. Receives: Drug: Pregnenolone 500 mg; Drug: Pregnenolone 800 mg; Drug: Placebo |
| Pregnenolone 800 > Pregnenolone 500 > Placebo | Experimental | 3 exposures in order:
1. Pregnenolone 800 mg capsule by mouth, daily for 7 days followed by 14 day washout.
2. Pregnenolone 500 mg capsule by mouth, daily for 7 days followed by 14 day washout.
3. Matching placebo capsule by mouth, daily for 7 days. Receives: Drug: Pregnenolone 500 mg; Drug: Pregnenolone 800 mg; Drug: Placebo |
| Pregnenolone 800 > Placebo > Pregnenolone 500 | Experimental | 3 exposures in order:
1. Pregnenolone 800 mg capsule by mouth, daily for 7 days followed by 14 day washout.
2. Matching placebo capsule by mouth, daily for 7 days followed by 14 day washout.
3. Pregnenolone 500 mg capsule by mouth, daily for 7 days. Receives: Drug: Pregnenolone 500 mg; Drug: Pregnenolone 800 mg; Drug: Placebo |
| Placebo > Pregnenolone 500 > Pregnenolone 800 | Experimental | 3 exposures in order:
1. Matching placebo capsule by mouth, daily for 7 days followed by 14 day washout.
2. Pregnenolone 500 mg capsule by mouth, daily for 7 days followed by 14 day washout.
3. Pregnenolone 800 mg capsule by mouth, daily for 7 days. Receives: Drug: Pregnenolone 500 mg; Drug: Pregnenolone 800 mg; Drug: Placebo |
| Placebo > Pregnenolone 800 > Pregnenolone 500 | Experimental | 3 exposures in order:
1. Matching placebo capsule by mouth, daily for 7 days followed by 14 day washout.
2. Pregnenolone 800 mg capsule by mouth, daily for 7 days followed by 14 day washout.
3. Pregnenolone 500 mg capsule by mouth, daily for 7 days. Receives: Drug: Pregnenolone 500 mg; Drug: Pregnenolone 800 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amygdala-PCC Functional Connectivity
Determine if an increase in Amygdala-PCC functional connectivity is observed with pregnenolone as compared to placebo.
Amygdala-PCC functional connectivity was measured using resting state fMRI blood-oxygen-level dependent (BOLD) response and transformed to standardized z-scores (with μ=0 and σ=1) for analysis. Functional connectivity was measured three times corresponding to three treatments (500 mg pregnenolone, 800 mg pregnenolone, and placebo). Better outcomes are represented by greater functional connectivity, and are indicated by a higher z-score at 500 mg or 800 mg, relative to that at placebo (i.e., there is no absolute threshold).
Measured: 7 days
dlPFC-Insula Functional Connectivity
Determine if an increase in dlPFC-Insula functional connectivity is observed with pregnenolone as compared to placebo.
dlPFC-Insula functional connectivity was measured using resting state fMRI blood-oxygen-level dependent (BOLD) response and transformed to standardized z-scores (with μ=0 and σ=1) for analysis. Functional connectivity was measured three times corresponding to three treatments (500 mg pregnenolone, 800 mg pregnenolone, and placebo). Better outcomes are represented by greater functional connectivity, and are indicated by a higher z-score at 500 mg or 800 mg, relative to that at placebo (i.e., there is no absolute threshold).
Measured: 7 days
GABA Concentration.
Determine if an increase in occipital GABA concentration is observed with pregnenolone, as compared to placebo.
Occipital GABA concentration using spectroscopy with tCr reference. Higher concentration values are representative of a greater anti-depressant effect.
Measured: 7 days
Secondary outcomes (4)
Pregnenolone Level
Assess bioavailability of pregnenolone by demonstrating increases in serum pregnenolone and allopregnanolone with pregnenolone administration. Change (increases) in blood serum pregnenolone levels are indicative of bioavailability.
Measured: 7 days
Allopregnanolone Level
Assess bioavailability of pregnenolone by demonstrating increases in serum pregnenolone and allopregnanolone with pregnenolone administration. Change (increases) in blood serum allopregnanolone levels are indicative of bioavailability.
Measured: 7 days
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Assess safety and tolerability of pregnenolone at the doses tested.
SAFTEE is a side effect self-report assessment scale that consists of 56 potential side effects. Participants rate how bothersome each side effect is on a scale of "none" (0), "mild" (1), "moderate" (2), "severe" (3). Total scores range from 0 to 168. A higher total score (sum of all items) indicates a higher level of side effect burden.
Measured: 7 days
Pregnenolone Dose
Identify a dose of pregnenolone that demonstrates bioavailability (see "Pregnenolone Level" and "Allopregnanolone Level" outcome measures), tolerability (see "SAFTEE" outcome measure); and is associated with a significant change in a biosignature.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Sep 2019
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Adult women with mild to moderate major depressive disorder (MDD) will receive pregnenolone (500 mg/d, 800 mg/d and placebo) in a randomized, double-blind, crossover design.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Sherwood Brown, MD, PhD, University of Texas Southwestern Medical Center
- Investigators
- Sherwood Brown, MD, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645096
- Sponsor's protocol ID
- STU 052018-030
- Other IDs
- 1R61AT009625-01A1
- Status last verified
- Apr 2024
- First submitted
- 22 Aug 2018
- Last updated
- 1 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NCCIH Development of Pregnenolone as a Treatment for Depression R61 Phase
- ClinicalTrials.gov ID
- NCT03645096
- Acronym / sponsor ID
- STU 052018-030
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, Pregnenolone, Women
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Posted 1 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pregnenolone, an over-the-counter supplement, is a naturally occurring neurosteroid made in the adrenal glands and brain. Preclinical research suggests pregnenolone has antidepressant, cognitive enhancing, and neuroprotective properties, particularly in women. The following hypothesis will be tested in this trial: pregnenolone is associated with improvement in depressive symptom severity in women that is associated with changes in the resting state functional connectivity (rsFC) and GABA.
Detailed description
In this study, 26 adult women meeting criteria for Major Depressive Disorder (MDD) as defined in DSM 5, will be randomized to a double-blind, placebo-controlled, crossover phase I clinical trial of pregnenolone (i.e. each participant receives 500 mg/d, 800 mg/d pregnenolone and placebo in random order). The study will consist of three 7-day treatment exposures to each pregnenolone dose with a 14-day washout between each exposure. Baseline evaluation will include medical and psychiatric history, psychiatric interview, standard laboratory analyses (i.e., blood draw, ECG), and a brief cognitive battery. Neuroimaging will be collected after each study drug or placebo administration. Study drug tolerability and participant safety will be assessed throughout the study (6 in-clinic visits + a safety visit) using structured clinical interviews, self-report questionnaires, and standard laboratory analyses.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
- Model description
- Adult women with mild to moderate major depressive disorder (MDD) will receive pregnenolone (500 mg/d, 800 mg/d and placebo) in a randomized, double-blind, crossover design.
| Arm | Type | Receives |
|---|---|---|
| Pregnenolone 500 > Pregnenolone 800 > Placebo | Experimental | Drug: Pregnenolone 500 mg, Drug: Pregnenolone 800 mg, Drug: Placebo3 exposures in order: 1. Pregnenolone 500 mg capsule by mouth, daily for 7 days followed by 14 day washout. 2. Pregnenolone 800 mg capsule by mouth, daily for 7 days followed by 14 day washout. 3. Matching placebo capsule by mouth, daily for 7 days. |
| Pregnenolone 500 > Placebo > Pregnenolone 800 | Experimental | Drug: Pregnenolone 500 mg, Drug: Pregnenolone 800 mg, Drug: Placebo3 exposures in order: 1. Pregnenolone 500 mg capsule by mouth, daily for 7 days followed by 14 day washout. 2. Matching placebo capsule by mouth, daily for 7 days followed by 14 day washout. 3. Pregnenolone 800 mg capsule by mouth, daily for 7 days. |
| Pregnenolone 800 > Pregnenolone 500 > Placebo | Experimental | Drug: Pregnenolone 500 mg, Drug: Pregnenolone 800 mg, Drug: Placebo3 exposures in order: 1. Pregnenolone 800 mg capsule by mouth, daily for 7 days followed by 14 day washout. 2. Pregnenolone 500 mg capsule by mouth, daily for 7 days followed by 14 day washout. 3. Matching placebo capsule by mouth, daily for 7 days. |
| Pregnenolone 800 > Placebo > Pregnenolone 500 | Experimental | Drug: Pregnenolone 500 mg, Drug: Pregnenolone 800 mg, Drug: Placebo3 exposures in order: 1. Pregnenolone 800 mg capsule by mouth, daily for 7 days followed by 14 day washout. 2. Matching placebo capsule by mouth, daily for 7 days followed by 14 day washout. 3. Pregnenolone 500 mg capsule by mouth, daily for 7 days. |
| Placebo > Pregnenolone 500 > Pregnenolone 800 | Experimental | Drug: Pregnenolone 500 mg, Drug: Pregnenolone 800 mg, Drug: Placebo3 exposures in order: 1. Matching placebo capsule by mouth, daily for 7 days followed by 14 day washout. 2. Pregnenolone 500 mg capsule by mouth, daily for 7 days followed by 14 day washout. 3. Pregnenolone 800 mg capsule by mouth, daily for 7 days. |
| Placebo > Pregnenolone 800 > Pregnenolone 500 | Experimental | Drug: Pregnenolone 500 mg, Drug: Pregnenolone 800 mg, Drug: Placebo3 exposures in order: 1. Matching placebo capsule by mouth, daily for 7 days followed by 14 day washout. 2. Pregnenolone 800 mg capsule by mouth, daily for 7 days followed by 14 day washout. 3. Pregnenolone 500 mg capsule by mouth, daily for 7 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women, ages 18-65 years, with current MDD (mild or moderate severity per DSM-5) based on SCID-CV.
- No psychotropic medications, other than PRN (as needed) hypnotics, within 28 days of randomization (medication free).
- PRN hypnotics allowed up to 3 days prior to study drug administrations but not while receiving study drug.
Key exclusion criteria (12 listed)
- Severe MDD based on DSM-5 severity criteria and/or a baseline HRSD score > 27 (consistent with severe depressive symptom severity).
- High risk for suicide (active SI with plan/intent or > 2 lifetime attempts in lifetime or any in the past 6 months).
- Treatment resistant depression (fail two adequate antidepressant trials or ECT during current episode).
- Vulnerable populations (e.g. pregnant/nursing, severe cognitive or intellectual impairment, incarcerated).
- Coronary artery disease, atrial fibrillation, stroke, deep vein thrombosis, pulmonary embolism or blood clotting disorder, or any severe, life threatening or unstable, medical condition.
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 |
|---|---|---|
| Pregnenolone 500 mgAlso: NeurosteroidPregnenolone 500 mg capsule. | Drug | Placebo > Pregnenolone 500 > Pregnenolone 800, Placebo > Pregnenolone 800 > Pregnenolone 500, Pregnenolone 500 > Placebo > Pregnenolone 800, Pregnenolone 500 > Pregnenolone 800 > Placebo, Pregnenolone 800 > Placebo > Pregnenolone 500, Pregnenolone 800 > Pregnenolone 500 > Placebo |
| Pregnenolone 800 mgAlso: NeurosteroidPregnenolone 800 mg capsule. | Drug | Placebo > Pregnenolone 500 > Pregnenolone 800, Placebo > Pregnenolone 800 > Pregnenolone 500, Pregnenolone 500 > Placebo > Pregnenolone 800, Pregnenolone 500 > Pregnenolone 800 > Placebo, Pregnenolone 800 > Placebo > Pregnenolone 500, Pregnenolone 800 > Pregnenolone 500 > Placebo |
| PlaceboPlacebo capsule manufactured to mimic pregnenolone capsule. | Drug | Placebo > Pregnenolone 500 > Pregnenolone 800, Placebo > Pregnenolone 800 > Pregnenolone 500, Pregnenolone 500 > Placebo > Pregnenolone 800, Pregnenolone 500 > Pregnenolone 800 > Placebo, Pregnenolone 800 > Placebo > Pregnenolone 500, Pregnenolone 800 > Pregnenolone 500 > Placebo |
Primary outcome
Amygdala-PCC Functional Connectivity
Time frame: 7 days
Determine if an increase in Amygdala-PCC functional connectivity is observed with pregnenolone as compared to placebo. Amygdala-PCC functional connectivity was measured using resting state fMRI blood-oxygen-level dependent (BOLD) response and transformed to standardized z-scores (with μ=0 and σ=1) for analysis. Functional connectivity was measured three times corresponding to three treatments (500 mg pregnenolone, 800 mg pregnenolone, and placebo). Better outcomes are represented by greater functional connectivity, and are indicated by a higher z-score at 500 mg or 800 mg, relative to that at placebo (i.e., there is no absolute threshold).
dlPFC-Insula Functional Connectivity
Time frame: 7 days
Determine if an increase in dlPFC-Insula functional connectivity is observed with pregnenolone as compared to placebo. dlPFC-Insula functional connectivity was measured using resting state fMRI blood-oxygen-level dependent (BOLD) response and transformed to standardized z-scores (with μ=0 and σ=1) for analysis. Functional connectivity was measured three times corresponding to three treatments (500 mg pregnenolone, 800 mg pregnenolone, and placebo). Better outcomes are represented by greater functional connectivity, and are indicated by a higher z-score at 500 mg or 800 mg, relative to that at placebo (i.e., there is no absolute threshold).
GABA Concentration.
Time frame: 7 days
Determine if an increase in occipital GABA concentration is observed with pregnenolone, as compared to placebo. Occipital GABA concentration using spectroscopy with tCr reference. Higher concentration values are representative of a greater anti-depressant effect.
4 secondary outcomes
Pregnenolone Level
Time frame: 7 days
Allopregnanolone Level
Time frame: 7 days
Systematic Assessment for Treatment Emergent Events (SAFTEE)
Time frame: 7 days
Pregnenolone Dose
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Sherwood Brown, MD, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pregnenolone 500 mg and Pregnenolone 800 mg in people with Major Depressive Disorder, run by University of Texas Southwestern 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 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 1 May 2024. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 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?
Amygdala-PCC Functional Connectivity (time frame: 7 days). The study lists 3 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 1 May 2024.