Healthy ParticipantsNCT03863691
Influence of Dopaminergic Blockade on Stress Responses, Motivation and Emotional Reactivity in Humans.
A study testing Amisulpride 300 MG in people with Healthy Participants, run by Philipps University Marburg at 1 site in Germany.
Trial summary
The study aims to identify whether partial blockade of human dopamine signaling with antipsychotic drugs affects human stress responses, motivation and emotion. 84 healthy adult participants are planned to complete the study protocol. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Amisulpride 300 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteGermany
- Study dates
- 15 Apr 2019to 15 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Common European Framework of Reference for Languages level B2 in German language.
- Consent ability for all relevant aspects of the experiment.
Who cannot join
- Amisulpride allergy.
- Allergy to other components of amisulpride / placebo capsules like lactose.
- Daily intake of other medication including contraceptives.
- Tendency to seizures.
- Diagnosis of cancer especially pheochromocytoma, prolactinoma, or breast cancer.
- Kidney dysfunction: creatinine clearance below 10 ml per minute.
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- High risk for stroke or thrombosis.
- Known prolongation of the QT interval,
- Any substantial medical condition that is capable of reducing the volunteers ability to participate at the study.
- Suicidal thoughts or suicide attempts in the past or at present.
- Substantial mental disorders especially schizophrenia, bipolar disorder, drug abuse, or personality disorders.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinical Psychology and Psychotherapy, Gutenbergstr. 18
Marburg, Hesse, 35037
About this study
Official title: Influence of Partial Blockade of Dopaminergic Neurotransmission Using Amisulpride on Stress Responsivity, Motivated Behavior and Emotional Reactivity in Humans.
The study aims to identify whether partial blockade of human dopamine signaling with antipsychotic drugs affects human stress responses, motivation and emotion. 84 healthy adult participants are planned to complete the study protocol.
Therefore three experiments are planned:
Experiment 1: Influence of amisulpride on human stress responses. Experiment 2: Influence of amisulpride on motivated effort. Experiment 3: Influence of amisulpride on emotion.
Read the detailed description
The study is a double blind, placebo controlled, randomized trial with two groups. One group will be receiving placebo (PG) and the other group will receive 300 mg amisulpride (VG). All participants are planned to complete all three experiments sequentially after drug/placebo intake.
In experiment 1 we want to test whether a medium single dosage of amisulpride (VG) changes human stress responses compared to the PG. Therefore test subjects take the medication / placebo and wait for peak plasma levels. Afterwards they undergo a standardized stress test (MAST procedure,e.g. Shilton et al., 2017) where they submerge their non-dominant hand in cold water and have to do mental arithmetic tasks. We collect ECG, cortisol and skin conductance data as well as subjective measures of the stress response.
In experiment 2 that is done after completion of experiment 1 the aim is testing whether the VG compared to the PG has an altered motivated effort. Therefore so called effort based paradigms (Reddy et al., 2015) are used. In these paradigms participants are given the option between an easy and effortless way of solving a trial that is reinforced with a small monetary reward or a harder and effortful way of trial solving that is rewarded higher. We measure how often the VG versus the PG will take the easy, low reward option over the hard, high reward option.
In experiment 3 and after the completion of experiment to the aim is it to test whether the mean intensity of visually evoked emotions in the VG is changed compared to the PG. Therefore we use a stimulus set (15 positive images, 15 negative images, 15 neutral images) out of the International Affective Picture System images to evoke emotions and plan to analyze data like in positivity offset research (detailed description in: Strauss et al, 2017).
- Conditions
- Healthy Participants
- Being tested
- Amisulpride 300 MG, Placebo oral capsule
- Keywords
- dopamine antagonists, dopamine blockade, psychophysiological stress response, Maastricht acute stress test (MAST), effort based paradigms, positivity offset theory, international affective picture system (IAPS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amisulpride 300 MGDrug
A single dose of 300 mg amisulpride that looks identical to placebo control capsules.
Placebo oral capsuleDrug
A placebo capsule with no inert pharmacological effect. Looks identical to the amisulpride capsules.
| Study group | Role | What they receive |
|---|---|---|
| amisulpride group | Active comparator | 300 mg of the atypical antipsychotic drug amisulpride Receives: Drug: Amisulpride 300 MG |
| placebo group | Placebo comparator | Similar looking capsules for placebo control Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived stress level from baseline to post stress period.
Before and after the stress test of experiment 1 we ask every participant for their perceived stress level. These data serve as an indicator of subjective stress responses. We analyze changes in subjective stress level compared to baseline measurements (76 min and 22 min before). Five minutes before the stress test starts we measure subjective anticipatory stress response and directly after the completion we measure post stressor responses and possible residual feelings of stress (16 minutes post completion).
All measurements reflect a single time series. Stress levels are obtained with visual analogue scales ranging from 0 (no stress) to 100 points (extremely stressed).
Measured: After preparation period. Before (76 min before, 22 min before, 5min before) and after the stress test (directly after, 16 min as well as 30 min after completion).
Percentage of difficult trials in the balloon effort task.
In experiment 2 which is a computer task, participants can choose between an easy task with low monetary reinforcement or a hard task with higher monetary reinforcement. "Easy" means that there is a low amount of physical or cognitive effort per trial and "hard" means that there is a higher amount of physical or cognitive effort per trial. From the tasks that are described in Reddy et al (2015) the balloon effort task (physical effort) and the deck choice task (mental effort) will be used. For both tasks our software automatically obtains the percentage of difficult trials with respect to the total number of trials. Note that only a single composite score is obtained after finishing the balloon effort task.
Measured: After the cortisol response of experiment 1 is subsided and directly when experiment is 2 is completely finished. This will be approximately 121 minutes after medication / placebo intake.
Percentage of difficult trials in the deck choice task.
In experiment 2 which is a computer task, participants can choose between an easy task with low monetary reinforcement or a hard task with higher monetary reinforcement. "Easy" means that there is a low amount of physical or cognitive effort per trial and "hard" means that there is a higher amount of physical or cognitive effort per trial. From the tasks that are described in Reddy et al (2015) the balloon effort task (physical effort) and the deck choice task (mental effort) will be used. For both tasks our software automatically obtains the percentage of difficult trials with respect to the total number of trials. Note that only a single composite score is obtained after finishing the deck choice effort task.
Measured: After finishing the balloon effort task. This will be approximately 145 minutes after medication / placebo intake.
Mean positive affect ratings in response to International Affective Picture System (IAPS) images.
Valence and arousal measures are collected as in Strauss et al. (2017) after presentation of IAPS pictures during experiment 3. Ratings for positive affect, negative affect and arousal ratings are obtained with a 10 point self-assessment manikin scale after the presentation of each individual picture. Note that only a single composite score for positive affect is calculated as the mean value of all evaluations following the individual pictures.
Measured: After experiment 3 is finished. This will be approximately 216 minutes after medication / placebo intake.
Mean negative affect ratings in response to International Affective Picture System (IAPS) images.
Valence and arousal measures are collected as in Strauss et al. (2017) after presentation of IAPS pictures during experiment 3. Ratings for positive affect, negative affect and arousal ratings are obtained with a 10 point self-assessment manikin scale. Note that only a single composite score for negative affect is calculated as the mean value of all evaluations following the individual pictures.
Measured: After experiment 3 is finished. This will be approximately 216 minutes after medication / placebo intake.
Secondary outcomes (3)
Saliva cortisol levels.
Before and at three time points after the stress test is completed of experiment 1 we take saliva cortisol samples of each participant. These samples are analysed for cortisol levels and serve as an indicator of Hypothalamic-pituitary-adrenal axis reactivity.
Cortisol levels are measured in nmol/liter.
Measured: After preparation period. Before (62 min before, 2 min before) and after the stress test (5, 15 and 25 min after completion).
Heart rate changes and changes in heart rate variability.
Before, during and after the stress test of experiment 1 we use blood volume pulse measures for obtaining heart rate data and calculate heart rate change scores and heart rate variability scores (HRV). These data serve as an indicator of cardiovascular stress responses.
Heart rate changes are measured in Δ1/s. Changes in heart rate variability is normalized for heart rate change because higher HR during stress exposure could induce a mathematical bias. Data that will be obtained include the low frequency band and the high frequency / low frequency ratio. A short introduction into the topic can be found in Billmann et al (2015).
Measured: After preparation period. Before (68 min before, 49 min before), during (the whole procedure) and after (directly after completion) the stress test.
Mean arousal ratings in response to International Affective Picture System (IAPS) images.
Valence and arousal measures are collected as in Strauss et al. (2017) after presentation of IAPS pictures during experiment 3. Ratings for positive affect, negative affect and arousal ratings are obtained with a 10 point self-assessment manikin scale. Note that only a single composite score for negative affect is calculated as the mean value of all evaluations following the individual pictures.
Measured: After experiment 3 is finished. This will be approximately 216 minutes after medication / placebo intake.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start15 Apr 2019
- Primary completion15 Jul 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Hamburg-Eppendorf
- Responsible party
- Sponsor
- Investigators
- Winfried Rief, Professor, Principal investigator, Philipps-Univeristy of Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863691
- Sponsor's protocol ID
- III/sja/kno FF96/2018
- Status last verified
- Sep 2020
- First submitted
- 22 Feb 2019
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Billman GE, Huikuri HV, Sacha J, Trimmel K. An introduction to heart rate variability: methodological considerations and clinical applications. Front Physiol. 2015 Feb 25;6:55. doi: 10.3389/fphys.2015.00055. eCollection 2015. No abstract available.
PubMed 25762937Horan WP, Reddy LF, Barch DM, Buchanan RW, Dunayevich E, Gold JM, Marder SR, Wynn JK, Young JW, Green MF. Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 2-External Validity and Correlates. Schizophr Bull. 2015 Sep;41(5):1055-65. doi: 10.1093/schbul/sbv090. Epub 2015 Jul 23.
PubMed 26209546Reddy LF, Horan WP, Barch DM, Buchanan RW, Dunayevich E, Gold JM, Lyons N, Marder SR, Treadway MT, Wynn JK, Young JW, Green MF. Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 1-Psychometric Characteristics of 5 Paradigms. Schizophr Bull. 2015 Sep;41(5):1045-54. doi: 10.1093/schbul/sbv089. Epub 2015 Jul 3.
PubMed 26142081Shilton AL, Laycock R, Crewther SG. The Maastricht Acute Stress Test (MAST): Physiological and Subjective Responses in Anticipation, and Post-stress. Front Psychol. 2017 Apr 19;8:567. doi: 10.3389/fpsyg.2017.00567. eCollection 2017.
PubMed 28469586Strauss GP, Frost KH, Lee BG, Gold JM. THE POSITIVITY OFFSET THEORY OF ANHEDONIA IN SCHIZOPHRENIA. Clin Psychol Sci. 2017 Mar;5(2):226-238. doi: 10.1177/2167702616674989. Epub 2017 Mar 10.
PubMed 28497008
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Partial Blockade of Dopaminergic Neurotransmission Using Amisulpride on Stress Responsivity, Motivated Behavior and Emotional Reactivity in Humans.
- ClinicalTrials.gov ID
- NCT03863691
- Acronym / sponsor ID
- III/sja/kno FF96/2018
- Conditions
- Healthy Participants
- Keywords
- dopamine antagonists, dopamine blockade, psychophysiological stress response, Maastricht acute stress test (MAST), effort based paradigms, positivity offset theory, international affective picture system (IAPS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Collaborators
- University of Hamburg-Eppendorf
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to identify whether partial blockade of human dopamine signaling with antipsychotic drugs affects human stress responses, motivation and emotion. 84 healthy adult participants are planned to complete the study protocol.
Therefore three experiments are planned:
Experiment 1: Influence of amisulpride on human stress responses. Experiment 2: Influence of amisulpride on motivated effort. Experiment 3: Influence of amisulpride on emotion.
Detailed description
The study is a double blind, placebo controlled, randomized trial with two groups. One group will be receiving placebo (PG) and the other group will receive 300 mg amisulpride (VG). All participants are planned to complete all three experiments sequentially after drug/placebo intake.
In experiment 1 we want to test whether a medium single dosage of amisulpride (VG) changes human stress responses compared to the PG. Therefore test subjects take the medication / placebo and wait for peak plasma levels. Afterwards they undergo a standardized stress test (MAST procedure,e.g. Shilton et al., 2017) where they submerge their non-dominant hand in cold water and have to do mental arithmetic tasks. We collect ECG, cortisol and skin conductance data as well as subjective measures of the stress response.
In experiment 2 that is done after completion of experiment 1 the aim is testing whether the VG compared to the PG has an altered motivated effort. Therefore so called effort based paradigms (Reddy et al., 2015) are used. In these paradigms participants are given the option between an easy and effortless way of solving a trial that is reinforced with a small monetary reward or a harder and effortful way of trial solving that is rewarded higher. We measure how often the VG versus the PG will take the easy, low reward option over the hard, high reward option.
In experiment 3 and after the completion of experiment to the aim is it to test whether the mean intensity of visually evoked emotions in the VG is changed compared to the PG. Therefore we use a stimulus set (15 positive images, 15 negative images, 15 neutral images) out of the International Affective Picture System images to evoke emotions and plan to analyze data like in positivity offset research (detailed description in: Strauss et al, 2017).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| amisulpride group | Active comparator | Drug: Amisulpride 300 MG300 mg of the atypical antipsychotic drug amisulpride |
| placebo group | Placebo comparator | Drug: Placebo oral capsuleSimilar looking capsules for placebo control |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Common European Framework of Reference for Languages level B2 in German language.
- Consent ability for all relevant aspects of the experiment.
Key exclusion criteria (12 listed)
- Amisulpride allergy.
- Allergy to other components of amisulpride / placebo capsules like lactose.
- Daily intake of other medication including contraceptives.
- Tendency to seizures.
- Diagnosis of cancer especially pheochromocytoma, prolactinoma, or breast cancer.
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 |
|---|---|---|
| Amisulpride 300 MGA single dose of 300 mg amisulpride that looks identical to placebo control capsules. | Drug | amisulpride group |
| Placebo oral capsuleA placebo capsule with no inert pharmacological effect. Looks identical to the amisulpride capsules. | Drug | placebo group |
Primary outcome
Change in Perceived stress level from baseline to post stress period.
Time frame: After preparation period. Before (76 min before, 22 min before, 5min before) and after the stress test (directly after, 16 min as well as 30 min after completion).
Before and after the stress test of experiment 1 we ask every participant for their perceived stress level. These data serve as an indicator of subjective stress responses. We analyze changes in subjective stress level compared to baseline measurements (76 min and 22 min before). Five minutes before the stress test starts we measure subjective anticipatory stress response and directly after the completion we measure post stressor responses and possible residual feelings of stress (16 minutes post completion). All measurements reflect a single time series. Stress levels are obtained with visual analogue scales ranging from 0 (no stress) to 100 points (extremely stressed).
Percentage of difficult trials in the balloon effort task.
Time frame: After the cortisol response of experiment 1 is subsided and directly when experiment is 2 is completely finished. This will be approximately 121 minutes after medication / placebo intake.
In experiment 2 which is a computer task, participants can choose between an easy task with low monetary reinforcement or a hard task with higher monetary reinforcement. "Easy" means that there is a low amount of physical or cognitive effort per trial and "hard" means that there is a higher amount of physical or cognitive effort per trial. From the tasks that are described in Reddy et al (2015) the balloon effort task (physical effort) and the deck choice task (mental effort) will be used. For both tasks our software automatically obtains the percentage of difficult trials with respect to the total number of trials. Note that only a single composite score is obtained after finishing the balloon effort task.
Percentage of difficult trials in the deck choice task.
Time frame: After finishing the balloon effort task. This will be approximately 145 minutes after medication / placebo intake.
In experiment 2 which is a computer task, participants can choose between an easy task with low monetary reinforcement or a hard task with higher monetary reinforcement. "Easy" means that there is a low amount of physical or cognitive effort per trial and "hard" means that there is a higher amount of physical or cognitive effort per trial. From the tasks that are described in Reddy et al (2015) the balloon effort task (physical effort) and the deck choice task (mental effort) will be used. For both tasks our software automatically obtains the percentage of difficult trials with respect to the total number of trials. Note that only a single composite score is obtained after finishing the deck choice effort task.
Mean positive affect ratings in response to International Affective Picture System (IAPS) images.
Time frame: After experiment 3 is finished. This will be approximately 216 minutes after medication / placebo intake.
Valence and arousal measures are collected as in Strauss et al. (2017) after presentation of IAPS pictures during experiment 3. Ratings for positive affect, negative affect and arousal ratings are obtained with a 10 point self-assessment manikin scale after the presentation of each individual picture. Note that only a single composite score for positive affect is calculated as the mean value of all evaluations following the individual pictures.
Mean negative affect ratings in response to International Affective Picture System (IAPS) images.
Time frame: After experiment 3 is finished. This will be approximately 216 minutes after medication / placebo intake.
Valence and arousal measures are collected as in Strauss et al. (2017) after presentation of IAPS pictures during experiment 3. Ratings for positive affect, negative affect and arousal ratings are obtained with a 10 point self-assessment manikin scale. Note that only a single composite score for negative affect is calculated as the mean value of all evaluations following the individual pictures.
3 secondary outcomes
Saliva cortisol levels.
Time frame: After preparation period. Before (62 min before, 2 min before) and after the stress test (5, 15 and 25 min after completion).
Heart rate changes and changes in heart rate variability.
Time frame: After preparation period. Before (68 min before, 49 min before), during (the whole procedure) and after (directly after completion) the stress test.
Mean arousal ratings in response to International Affective Picture System (IAPS) images.
Time frame: After experiment 3 is finished. This will be approximately 216 minutes after medication / placebo intake.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Background: PubMed 25762937Billman GE, Huikuri HV, Sacha J, Trimmel K. An introduction to heart rate variability: methodological considerations and clinical applications. Front Physiol. 2015 Feb 25;6:55. doi: 10.3389/fphys.2015.00055. eCollection 2015. No abstract available.
- Background: PubMed 26209546Horan WP, Reddy LF, Barch DM, Buchanan RW, Dunayevich E, Gold JM, Marder SR, Wynn JK, Young JW, Green MF. Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 2-External Validity and Correlates. Schizophr Bull. 2015 Sep;41(5):1055-65. doi: 10.1093/schbul/sbv090. Epub 2015 Jul 23.
- Background: PubMed 26142081Reddy LF, Horan WP, Barch DM, Buchanan RW, Dunayevich E, Gold JM, Lyons N, Marder SR, Treadway MT, Wynn JK, Young JW, Green MF. Effort-Based Decision-Making Paradigms for Clinical Trials in Schizophrenia: Part 1-Psychometric Characteristics of 5 Paradigms. Schizophr Bull. 2015 Sep;41(5):1045-54. doi: 10.1093/schbul/sbv089. Epub 2015 Jul 3.
- Background: PubMed 28469586Shilton AL, Laycock R, Crewther SG. The Maastricht Acute Stress Test (MAST): Physiological and Subjective Responses in Anticipation, and Post-stress. Front Psychol. 2017 Apr 19;8:567. doi: 10.3389/fpsyg.2017.00567. eCollection 2017.
- Background: PubMed 28497008Strauss GP, Frost KH, Lee BG, Gold JM. THE POSITIVITY OFFSET THEORY OF ANHEDONIA IN SCHIZOPHRENIA. Clin Psychol Sci. 2017 Mar;5(2):226-238. doi: 10.1177/2167702616674989. Epub 2017 Mar 10.
- 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.
Winfried Rief, Professor principal investigator
Philipps-Univeristy of Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amisulpride 300 MG in people with Healthy Participants, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 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 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Perceived stress level from baseline to post stress period. (time frame: After preparation period. Before (76 min before, 22 min before, 5min before) and after the stress test (directly after, 16 min as well as 30 min after completion).). The study lists 5 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 NCT03863691, which also lists 5 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 21 Sep 2020.