Bipolar II DisorderPhase 1HAPNCT03810703

Differential Responses to Drugs and Sweet Tastes

A Phase 1 study testing d-amphetamine 10 mg oral capsule and d-amphetamine 20 mg oral capsule in people with Bipolar II Disorder, run by University of Chicago at 2 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 19 yearsHealthy volunteers can take part
Conditions the study is for: Bipolar II Disorder
What is being tested?: d-amphetamine 10 mg oral capsule and d-amphetamine 20 mg oral capsule
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 93 participants
Where: 2 sitesUnited States
Study dates: 9 Feb 2017to 9 Aug 2018
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 19 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Aged 18-19 years old
BMI of 19-26
Physical/EKG/Medical History/Medications Approved by Physician for d-amphetamine
at least High School education
Fluent in English

Who cannot join

No Current Mood, Anxiety, Eating or Psychotic Disorder
No current psychotropic medication
No Recent Drug Dependence
< 4 alcoholic drinks/day for males; < 3 alcoholic drinks/day for females (monthly average)
No weekly (or more frequent) illicit drug use
No women who are pregnant, nursing, or planning pregnancy within 3 months (birth control is okay)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Chicago Medical Center - Human Behavioral Pharmacology Lab
Chicago, Illinois, 60637
University of Chicago
Chicago, Illinois, 60637

Other trials in United States

About this study

Official title: Hypomania, Amphetamine, and Preferences for Sweets

Young adults who exhibit "bipolar phenotype" (BPP), defined as occasional episodes of mood elevation and heightened activity, are at risk for several psychiatric disorders, including problem use of drugs and alcohol. Mood elevation has been linked to higher alcohol consumption and alcohol use disorders. Individuals with BPP show elevated lifetime prevalence of alcohol use disorders (between 39%-61%), figures that exceed those reported in both major depression and schizophrenia. Recently, the investigators demonstrated in a controlled laboratory study that individuals with BPP (but not meeting criteria for full Bipolar I Disorder), report dampened responses to a single dose of alcohol, compared to placebo. In the current study, the investigators seek to extend these findings to determine if young adults reporting BPP, based on a questionnaire, will exhibit reduced responses to other rewarding stimuli, such as d-amphetamine and sweet tastes. The investigators hypothesize that the BPP individuals will exhibit dampened subjective responses to stimulant and sweet taste rewards compared to healthy controls.

Read the detailed description

This study will extend the understanding of risk factors for drug or alcohol misuse, or other reward-related behaviors. The investigators previously showed that individuals who report occasional feelings of high energy and excitability experience less effect from a single dose of alcohol, compared to people who have not experienced these effects. Now the investigators wish to determine if this dampened response also occurs with other rewards, namely feelings of wellbeing after a dose of amphetamine, or liking of a sweet solution. Individuals who exhibit the BPP (i.e., periods of excitability) also are more likely to develop alcohol problems, substance misuse, and weight gain and obesity. Therefore, the investigators will test the working hypothesis that young adults who report having these experiences, based on a questionnaire measure (i.e., BPP individuals) will show dampened subjective responses to both single oral doses of amphetamine or sweet palatable tastes. The investigators will also obtain objective measures (e.g. Respiratory Sinus Arrhythmia and heart rate) to amphetamine and sweet taste, to establish whether the dampened subjective response extends to physiological indices as well. This study will extend the previous literature regarding the blunted effects of alcohol in BPP individuals and will suggest possible mechanisms that promote broader addictive behaviors in individuals with mood disturbance. Importantly, the investigators are proposing to test individuals at a relatively young age, 18-19 years. This is important to identify a risk factor, that is thought to pre-date use of drugs. In older participants, it would be difficult to separate the role of the pre-existing trait from the effect of habitual drug or alcohol use that escalates markedly after age 20.

Conditions: Bipolar II Disorder
Being tested: Placebo oral capsule, d-amphetamine 10 mg oral capsule, d-amphetamine 20 mg oral capsule
Medical subject headings: Bipolar Disorder

What participants receive

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

Placebo oral capsuleDrug
Placebo oral capsule
d-amphetamine 10 mg oral capsuleDrug
d-amphetamine 10 mg oral capsule
d-amphetamine 20 mg oral capsuleDrug
d-amphetamine 20 mg oral capsule

Study groups in NCT03810703
Study group	Role	What they receive
placebo arm	Placebo comparator	Participant will receive placebo oral capsule during this four hour session. Receives: Drug: Placebo oral capsule
amphetamine 10 mg arm	Experimental	Participant will receive d-amphetamine 10 mg oral capsule during this four hour session. Receives: Drug: d-amphetamine 10 mg oral capsule
amphetamine 20 mg arm	Experimental	Participant will receive d-amphetamine 20 mg oral capsule during this four hour session. Receives: Drug: d-amphetamine 20 mg oral capsule

What is being measured

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

Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ).
Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales are scored on a visual analogue scale (Scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.
Measured: End of study (Baseline - time 0 and approximately 4 weeks later)

Timeline

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

9 Feb 20179 Aug 2018

First posted22 Jan 2019
Study start9 Feb 2017
Primary completion9 Aug 2018
Study completion9 Aug 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 (21)Papers the sponsor has linked to this study.
Other trials for Bipolar II DisorderStudies of the same condition, open and under way.
More trials run by University of ChicagoThe 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: Parallel groups
Model description: Study will track participants in two assigned groups (participants that exhibit either High or Low Bipolar II/Hypomanic phenotypes)
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03810703
Sponsor's protocol ID: IRB16-1293
Acronym: HAP
Status last verified: May 2022
First submitted: 1 Aug 2017
Last updated: 22 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Calabrese JR, Hirschfeld RM, Reed M, Davies MA, Frye MA, Keck PE, Lewis L, McElroy SL, McNulty JP, Wagner KD. Impact of bipolar disorder on a U.S. community sample. J Clin Psychiatry. 2003 Apr;64(4):425-32. doi: 10.4088/jcp.v64n0412.
PubMed 12716245
Chandler RA, Wang PW, Ketter TA, Goodwin GM. A new US-UK diagnostic project: mood elevation and depression in first-year undergraduates at Oxford and Stanford universities. Acta Psychiatr Scand. 2008 Jul;118(1):81-5. doi: 10.1111/j.1600-0447.2008.01193.x.
PubMed 18595178
de Lauzon B, Romon M, Deschamps V, Lafay L, Borys JM, Karlsson J, Ducimetiere P, Charles MA; Fleurbaix Laventie Ville Sante Study Group. The Three-Factor Eating Questionnaire-R18 is able to distinguish among different eating patterns in a general population. J Nutr. 2004 Sep;134(9):2372-80. doi: 10.1093/jn/134.9.2372.
PubMed 15333731
Francis LJ, Robbins M, Louden SH, Haley JM. A revised psychoticism scale for the revised Eysenck personality questionnaire: a study among clergy. Psychol Rep. 2001 Jun;88(3 Pt 2):1131-4. doi: 10.2466/pr0.2001.88.3c.1131.
PubMed 11597066
Williams JB, Gibbon M, First MB, Spitzer RL, Davies M, Borus J, Howes MJ, Kane J, Pope HG Jr, Rounsaville B, et al. The Structured Clinical Interview for DSM-III-R (SCID). II. Multisite test-retest reliability. Arch Gen Psychiatry. 1992 Aug;49(8):630-6. doi: 10.1001/archpsyc.1992.01820080038006.
PubMed 1637253
Grossman P, Taylor EW. Toward understanding respiratory sinus arrhythmia: relations to cardiac vagal tone, evolution and biobehavioral functions. Biol Psychol. 2007 Feb;74(2):263-85. doi: 10.1016/j.biopsycho.2005.11.014. Epub 2006 Nov 1.
PubMed 17081672
Grossman P, van Beek J, Wientjes C. A comparison of three quantification methods for estimation of respiratory sinus arrhythmia. Psychophysiology. 1990 Nov;27(6):702-14. doi: 10.1111/j.1469-8986.1990.tb03198.x.
PubMed 2100356
Haertzen CA. Development of scales based on patterns of drug effects, using the addiction Research Center Inventory (ARCI). Psychol Rep. 1966 Feb;18(1):163-94. doi: 10.2466/pr0.1966.18.1.163. No abstract available.
PubMed 5908477
Hoeppner BB, Stout RL, Jackson KM, Barnett NP. How good is fine-grained Timeline Follow-back data? Comparing 30-day TLFB and repeated 7-day TLFB alcohol consumption reports on the person and daily level. Addict Behav. 2010 Dec;35(12):1138-43. doi: 10.1016/j.addbeh.2010.08.013. Epub 2010 Aug 13.
PubMed 20822852
Hirschfeld RM, Holzer C, Calabrese JR, Weissman M, Reed M, Davies M, Frye MA, Keck P, McElroy S, Lewis L, Tierce J, Wagner KD, Hazard E. Validity of the mood disorder questionnaire: a general population study. Am J Psychiatry. 2003 Jan;160(1):178-80. doi: 10.1176/appi.ajp.160.1.178.
PubMed 12505821
Waleeprakhon P, Ittasakul P, Lotrakul M, Wisajun P, Jullagate S, Ketter TA. Development and validation of a screening instrument for bipolar spectrum disorder: The Mood Disorder Questionnaire Thai version. Neuropsychiatr Dis Treat. 2014 Aug 18;10:1497-502. doi: 10.2147/NDT.S67842. eCollection 2014.
PubMed 25170269
Jacob T, Seilhamer RA, Bargeil K, Howell DN. Reliability of Lifetime Drinking History among alcohol dependent men. Psychol Addict Behav. 2006 Sep;20(3):333-7. doi: 10.1037/0893-164X.20.3.333.
PubMed 16938072
Johanson CE, Uhlenhuth EH. Drug preference and mood in humans: d-amphetamine. Psychopharmacology (Berl). 1980;71(3):275-9. doi: 10.1007/BF00433062.
PubMed 6779335
Kessler RC, Crum RM, Warner LA, Nelson CB, Schulenberg J, Anthony JC. Lifetime co-occurrence of DSM-III-R alcohol abuse and dependence with other psychiatric disorders in the National Comorbidity Survey. Arch Gen Psychiatry. 1997 Apr;54(4):313-21. doi: 10.1001/archpsyc.1997.01830160031005.
PubMed 9107147
Regier DA, Farmer ME, Rae DS, Locke BZ, Keith SJ, Judd LL, Goodwin FK. Comorbidity of mental disorders with alcohol and other drug abuse. Results from the Epidemiologic Catchment Area (ECA) Study. JAMA. 1990 Nov 21;264(19):2511-8.
PubMed 2232018

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?

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All Bipolar II Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Hypomania, Amphetamine, and Preferences for Sweets
ClinicalTrials.gov ID: NCT03810703
Acronym / sponsor ID: HAP / IRB16-1293
Conditions: Bipolar II Disorder
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: University of ChicagoUniversity, hospital or other
Study start: 9 Feb 2017 (actual)
Primary completion: 9 Aug 2018 (actual)
Study completion: 9 Aug 2018 (actual)
First posted: 22 Jan 2019 (actual)
Results: Posted 22 Feb 2023

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

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3
Model description: Study will track participants in two assigned groups (participants that exhibit either High or Low Bipolar II/Hypomanic phenotypes)

Arm	Type	Receives
placebo arm	Placebo comparator	Drug: Placebo oral capsuleParticipant will receive placebo oral capsule during this four hour session.
amphetamine 10 mg arm	Experimental	Drug: d-amphetamine 10 mg oral capsuleParticipant will receive d-amphetamine 10 mg oral capsule during this four hour session.
amphetamine 20 mg arm	Experimental	Drug: d-amphetamine 20 mg oral capsuleParticipant will receive d-amphetamine 20 mg oral capsule during this four hour session.

Who may qualify

Ages: 18 to 19 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Aged 18-19 years old
BMI of 19-26
Physical/EKG/Medical History/Medications Approved by Physician for d-amphetamine
at least High School education
Fluent in English

Key exclusion criteria (6 listed)

No Current Mood, Anxiety, Eating or Psychotic Disorder
No current psychotropic medication
No Recent Drug Dependence
< 4 alcoholic drinks/day for males; < 3 alcoholic drinks/day for females (monthly average)
No weekly (or more frequent) illicit drug use

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
Placebo oral capsulePlacebo oral capsule	Drug	placebo arm
d-amphetamine 10 mg oral capsuled-amphetamine 10 mg oral capsule	Drug	amphetamine 10 mg arm
d-amphetamine 20 mg oral capsuled-amphetamine 20 mg oral capsule	Drug	amphetamine 20 mg arm

Primary outcome

Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ).
Time frame: End of study (Baseline - time 0 and approximately 4 weeks later)
Participants will complete The Drug Effects Questionnaire during the initial baseline session to determine their subjective stimulant profile. The Dug Effects Questionnaire (DEQ) is a visual analog scale questionnaire that assesses the extent to which subjects experience four subjective states: "Feel Drug", "Feel High", "Like Drug", and "Want More". All sub-scales are scored on a visual analogue scale (Scroll bar on computer screen) ranging from 0-100. 100 represents the highest score for that subjective state, and the higher the score, the worse the outcome.

Results and safety

Results posted to the registry on 22 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Arm	31	31
Amphetamine 10 mg Arm	31	31
Amphetamine 20 mg Arm	31	31

Primary outcome: Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ).

Time frame: End of study (Baseline - time 0 and approximately 4 weeks later). Mean (Standard Error). Unit: score on a scale

Measure	Placebo Arm n = 31	Amphetamine 10 mg Arm n = 31	Amphetamine 20 mg Arm n = 31
Feel	18.88 (8.84)	35.25 (4.46)	45.75 (8.23)
Like	37.44 (7.64)	50.69 (7.82)	52.81 (8.96)
Dislike	19.00 (5.96)	27.19 (6.47)	16.25 (5.15)
High	17.50 (5.50)	24.88 (5.48)	32.69 (8.68)
More	29.19 (7.56)	45.38 (7.66)	52.44 (8.40)

Adverse events

Time frame: Through study completion, an average of 5 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Arm	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Amphetamine 10 mg Arm	0 of 31 (0%)	0 of 31 (0%)	0 of 31
Amphetamine 20 mg Arm	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12716245Calabrese JR, Hirschfeld RM, Reed M, Davies MA, Frye MA, Keck PE, Lewis L, McElroy SL, McNulty JP, Wagner KD. Impact of bipolar disorder on a U.S. community sample. J Clin Psychiatry. 2003 Apr;64(4):425-32. doi: 10.4088/jcp.v64n0412.
Background: PubMed 18595178Chandler RA, Wang PW, Ketter TA, Goodwin GM. A new US-UK diagnostic project: mood elevation and depression in first-year undergraduates at Oxford and Stanford universities. Acta Psychiatr Scand. 2008 Jul;118(1):81-5. doi: 10.1111/j.1600-0447.2008.01193.x.
Background: PubMed 15333731de Lauzon B, Romon M, Deschamps V, Lafay L, Borys JM, Karlsson J, Ducimetiere P, Charles MA; Fleurbaix Laventie Ville Sante Study Group. The Three-Factor Eating Questionnaire-R18 is able to distinguish among different eating patterns in a general population. J Nutr. 2004 Sep;134(9):2372-80. doi: 10.1093/jn/134.9.2372.
Background: PubMed 11597066Francis LJ, Robbins M, Louden SH, Haley JM. A revised psychoticism scale for the revised Eysenck personality questionnaire: a study among clergy. Psychol Rep. 2001 Jun;88(3 Pt 2):1131-4. doi: 10.2466/pr0.2001.88.3c.1131.
Background: PubMed 1637253Williams JB, Gibbon M, First MB, Spitzer RL, Davies M, Borus J, Howes MJ, Kane J, Pope HG Jr, Rounsaville B, et al. The Structured Clinical Interview for DSM-III-R (SCID). II. Multisite test-retest reliability. Arch Gen Psychiatry. 1992 Aug;49(8):630-6. doi: 10.1001/archpsyc.1992.01820080038006.
Background: PubMed 17081672Grossman P, Taylor EW. Toward understanding respiratory sinus arrhythmia: relations to cardiac vagal tone, evolution and biobehavioral functions. Biol Psychol. 2007 Feb;74(2):263-85. doi: 10.1016/j.biopsycho.2005.11.014. Epub 2006 Nov 1.
Background: PubMed 2100356Grossman P, van Beek J, Wientjes C. A comparison of three quantification methods for estimation of respiratory sinus arrhythmia. Psychophysiology. 1990 Nov;27(6):702-14. doi: 10.1111/j.1469-8986.1990.tb03198.x.
Background: PubMed 5908477Haertzen CA. Development of scales based on patterns of drug effects, using the addiction Research Center Inventory (ARCI). Psychol Rep. 1966 Feb;18(1):163-94. doi: 10.2466/pr0.1966.18.1.163. No abstract available.
Background: PubMed 20822852Hoeppner BB, Stout RL, Jackson KM, Barnett NP. How good is fine-grained Timeline Follow-back data? Comparing 30-day TLFB and repeated 7-day TLFB alcohol consumption reports on the person and daily level. Addict Behav. 2010 Dec;35(12):1138-43. doi: 10.1016/j.addbeh.2010.08.013. Epub 2010 Aug 13.
Background: PubMed 12505821Hirschfeld RM, Holzer C, Calabrese JR, Weissman M, Reed M, Davies M, Frye MA, Keck P, McElroy S, Lewis L, Tierce J, Wagner KD, Hazard E. Validity of the mood disorder questionnaire: a general population study. Am J Psychiatry. 2003 Jan;160(1):178-80. doi: 10.1176/appi.ajp.160.1.178.
Background: PubMed 25170269Waleeprakhon P, Ittasakul P, Lotrakul M, Wisajun P, Jullagate S, Ketter TA. Development and validation of a screening instrument for bipolar spectrum disorder: The Mood Disorder Questionnaire Thai version. Neuropsychiatr Dis Treat. 2014 Aug 18;10:1497-502. doi: 10.2147/NDT.S67842. eCollection 2014.
Background: PubMed 16938072Jacob T, Seilhamer RA, Bargeil K, Howell DN. Reliability of Lifetime Drinking History among alcohol dependent men. Psychol Addict Behav. 2006 Sep;20(3):333-7. doi: 10.1037/0893-164X.20.3.333.
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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing d-amphetamine 10 mg oral capsule and d-amphetamine 20 mg oral capsule in people with Bipolar II Disorder, run by University of Chicago at 2 sites 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 5 inclusion and 6 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 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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 22 Feb 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?

Change in Subjective Effects as Assessed by Score on "Feel Drug", "Feel High", "Like Drug", and "Want More" Sub-scales of Drug Effects Questionnaire (DEQ). (time frame: End of study (Baseline - time 0 and approximately 4 weeks later)). 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 NCT03810703, which also lists 21 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 22 Feb 2023.