Intrusive ThoughtTRAUMA-PRONCT04508166
Towards a Post-exposition Pharmacological Prophylaxis for Post-traumatic Stress Disorder
A study testing Dexmedetomidine, Gamma-Hydroxybutyrate and Experimental Model Trauma Film in people with Intrusive Thought and Psychological Trauma, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
Trial summary
In this study, we investigate the role that deep sleep plays in the prevention of posttraumatic stress disorder after someone has been exposed to a trauma by boosting deep sleep with two drug conditions compared to placebo condition. Each volunteer in the study goes through all three conditions. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Intrusive Thought, Psychological Trauma, Inflammatory Response
- What is being tested?
- Dexmedetomidine, Gamma-Hydroxybutyrate and Experimental Model Trauma Film
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2021to 29 Jan 2022
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Speaks and understands German
- BMI 18.5 -< 25
- Non-smoker status
- Habitual 5 or fewer alcoholic beverages / week
- Habitual 3 or fewer caffeinated beverages / day
- Habitual average sleep duration 7-9 h / night
- Normal or corrected-to-normal vision
- Insomnia Severity Index score between 8-14
Who cannot join
- Travel across 3 or more time zones within 3 months of study start
- Habitual napping
- Extreme chronotype, determined by Morningness-Eveningness Questionnaire
- History of or presence of a trauma- or stressor-related disorder
- History of or presence of neurological disorder, psychiatric disorder or head injury
- History of or presence of a sleep disorder
Show all 11Show fewer
- History of or presence of cardiovascular disorder
- Use of illicit drugs
- Atypical preference for excessively violent portrayals
- Faints at the site of blood or brutality
- Has participated in a study < 30 days or a study such as this (i.e., experimental trauma) at all.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacological Prevention of Post-traumatic Intrusions in Healthy Volunteers - Towards a Post-exposition Prophylaxis for Post-traumatic Stress Disorder
In this study, we investigate the role that deep sleep plays in the prevention of posttraumatic stress disorder after someone has been exposed to a trauma by boosting deep sleep with two drug conditions compared to placebo condition. Each volunteer in the study goes through all three conditions. The quantity of intrusive memories of the trauma will be compared between the three conditions.
Read the detailed description
The present study seeks to investigate the potential to pharmacologically modulate slow-wave sleep in the acute aftermath of an experimentally-induced trauma in the interest of developing a secondary prevention of posttraumatic stress disorder. The effects of a GABAergic compound will be compared with that of a noradrenergic compound. Memory, sleep and stress-related immune response factors will be quantified and compared across drug conditions.
- Being tested
- Dexmedetomidine, Gamma-Hydroxybutyrate, Placebo, Experimental Model Trauma Film
- Medical subject headings
- Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexdor
Volunteers receive a single dose of dexmedetomidine sublingually at scheduled bedrest in the sleep laboratory
Gamma-HydroxybutyrateDrug
Also called Xyrem
Volunteers receive a single oral dose of gamma-hydroxybutyrate at scheduled bedrest in the sleep laboratory
PlaceboDrug
Volunteers receive an oral (saline) or sublingual (orodispersible tablet) at scheduled bedrest in the sleep laboratory
Experimental Model Trauma FilmBehavioural
Each volunteer views experimental model trauma film before scheduled bedrest in the sleep laboratory. This video is ca. 15 minutes in duration and is composed of short (a few seconds to a few minutes) individual and unrelated scenes of violent death and injury of varying description. Six versions of the film without re-occurring scenes will be presented in balanced order across drug order conditions.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Sublingual dose of dexmedetomidine Receives: Drug: Dexmedetomidine; Drug: Placebo; Behavioral: Experimental Model Trauma Film |
| Gamma-hydroxybutyrate | Active comparator | Oral dose of gamma-hydroxybutyrate Receives: Drug: Gamma-Hydroxybutyrate; Drug: Placebo; Behavioral: Experimental Model Trauma Film |
| Placebo | Placebo comparator | Oral (saline) and sublingual (orodispersible tablet) doses Receives: Drug: Dexmedetomidine; Drug: Placebo; Behavioral: Experimental Model Trauma Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of intrusive memories
The number of intrusive memories of the experimental model trauma film experienced. The number of intrusive memories will be recorded in a diary by participants.
Measured: Three weeks
Emotional valence of intrusive memories
The emotional valence will be recorded in a diary after experiencing an intrusive memory in an integer scale. The integer scale will range from 1 to 10, where 1 indicates the lowest and 10 indicates the highest.
Measured: Three weeks
Personal significance of intrusive memories
Personal significance of intrusive memories will be recorded in a diary after experiencing an intrusive memory in an integer scale. The integer scale will range from 1 to 10, where 1 indicates the lowest and 10 indicates the highest.
Measured: Three weeks
Oscillatory delta power in the sleep electroencephalogram (EEG) during non rapid eye movement (REM) sleep stages N2 and N3
Power in units microvolts squared will be quantified by fast Fourier transform in 4 second segment length in EEG sleep recordings in the delta frequency bin (0.5 - 4.5 Hz).Higher value of delta power indicates greater homeostatic sleep pressure, i.e., the feeling of need for sleep.
Measured: Four nights, each night a week apart, spanning one month
Oscillatory theta power in the sleep electroencephalogram (EEG) during non rapid eye movement sleep stages N2 and N3
Power in units microvolts squared will be quantified by fast Fourier transform in 4 second segment length in EEG sleep recordings in the theta frequency bin (6 - 9 Hz). Higher value of theta power indicates greater homeostatic sleep pressure, i.e., the feeling of need for sleep.
Measured: Four nights, each night a week apart, spanning one month
EEG measures of sleep quality: distribution of N2 and N3 sleep stages.
Number of non-REM sleep stages N2 and N3. Greater number of stages N2 and N3 indicate greater homeostatic sleep pressure, i.e., the feeling of need for sleep.
Measured: Four nights, each night a week apart, spanning one month
EEG measures of sleep quality: number of arousals
Number of arousals Arousals are defined by the American Academy of Sleep Medicine as an increase in EEG frequency at least 3 seconds in NREM sleep in alpha, theta or higher frequencies, excluding spindles; must be accompanied by a minimum of 1 second of muscle activity during REM sleep. The greater the number of arousals indicates the lower homeostatic sleep pressure is in healthy individuals. Normal number of arousals for a healthy adult is ca. 80 per 8 hour sleep episode.
Measured: Four nights, each night a week apart, spanning one month
EEG measures of sleep quality: sleep onset latency
Sleep onset latency represents elapsed time from intention to initiate sleep until sleep is initiated (defined as the occurrence of any stage of sleep by the AASM). Longer latencies indicate lower homeostatic sleep pressure or some maladaptive, e.g., rumination, stress, or pathological state, e.g., insomnia, posttraumatic stress. Normal latencies for healthy adults is 10 - 20 minutes.
Measured: Four nights, each night a week apart, spanning one month
EEG measures of sleep quality: sleep duration
Sleep duration represents the duration in time of a sleep episode excluding any intervening stages of waking. Typical sleep duration in the healthy adult population is ca. 8 hours. Extreme sleep durations (<5 or <6 hr or >10 hr) have been associated with cardiometabolic illness risk.
Measured: Four nights, each night a week apart, spanning one month
EEG measures of sleep quality: sleep efficiency
Sleep efficiency represents how efficient a given sleep episode is and is defined as the duration of sleep (i.e., time spent in all NREM and REM sleep stages) divided b by the total time spent in bed and multiplied by 100. Normal sleep efficiency is 80% or greater. Efficiencies less than this value could raise questions of sleep satiety, maladaptive behavior (e.g., alcohol consumption, caffeine consumption, sleep at incongruent circadian phase) or pathological health conditions (e.g., restless legs, disordered breathing, insomnia).
Measured: Four nights, each night a week apart, spanning one month
Secondary outcomes (10)
Physiological stress: circulating cortisol
Cortisol (nmol/l) is a marker of stress activation and will be quantified by salivary assay. Greater values indicate greater stress response. Salivary cortisol concentrations vary by sex; in males it ranges under normal conditions from 1-50 nmol/l.
Measured: Four nights, each morning a week apart, spanning one month
Physiological stress: electrocardiogram (ECG) heart rate (HR)
Average resting ECG HR during waking in healthy adult males is 75 bpm (range: 60 - 100 bpm). Higher HR from an individual's baseline HR during and after experimental model trauma will be indicative of increases in sympathetic activation of heart function.
Measured: Four nights, each night a week apart, spanning one month
Physiological stress: respirometry respiration rate
Resting respiration rate of an adult male is 12 - 16 breaths per minute. Increases in the number of breaths per minute will indicate increase in sympathetic activation of the autonomic system.
Measured: Four nights, each night a week apart, spanning one month
Physiological stress: electrocardiogram (ECG) heart rate variability (HRV)
Heart rate variability will be quantified by measuring inter-beat intervals of the ECG. The normal-to-normal interval will be taken, which is the interpolated interval between normal R peaks of the QRS wave complex of the ECG. HRV values indicate performance of the autonomic nervous system in a given context. Higher values of sympathetic activation will be expected during experimental model trauma film exposure.
Measured: Four nights, each night a week apart, spanning one month
Physiological stress: inflammatory immune factors (cytokines and kynurenines)
Lower concentration values of immune factors will be expected in GHB or DMTN conditions compared to placebo conditions.
Measured: Four mornings, each morning a week apart, spanning one month
Subjective ratings of mood: Positive and Negative Affect Scale (PANAS)
The PANAS scale assesses affect and is comprised of a positive affect subscales and a negative affect subscale. The range of scores of either are 10 - 50. Higher scores in the positive subscale indicate higher (i.e., "better") mood; lower scores in the negative affect subscale indicate lower (i.e., "worse") mood. Mean (i.e., scores for normal healthy adults) respective scores for the positive and negative subscales are 33.3 (standard deviation [SD] = 7.2) and 17.4 (SD = 6.2).
Measured: Four nights, each night a week apart, spanning one month
Subjective ratings of mood: State Trait Anxiety Inventory (STAI)
The STAI assesses anxiety and is composed of a state and a trait scale. Scores in either can range from 20 - 80, and higher scores indicate greater anxiety. Mean scores for healthy adult males of the state and trait scales are, respectively 35.7 (SD = 10.4) and 34.9 (SD = 9.2).
Measured: Four nights, each night a week apart, spanning one month
Awakening response: cortisol
Salivary cortisol samples will be taken at regular intervals each morning in the lab to assess the awakening response. Higher values of cortisol concentrations indicate an stronger signal in this process of gaining alertness after sleep.
Measured: Four mornings, each morning a week apart, spanning one month
Awakening response: Psychomotor Vigilance Task (PVT)
To assess behavioral response to awaking after sleep, a simple 10 minute reaction time task at the computer called the PVT will be administered. Typical reaction times for an adult are < 500 ms from stimulus presentation. Higher values will be expected for greater degree of sleep inertia after awakening.
Measured: Four mornings, each morning a week apart, spanning one month
Sleep inertia Questionnaire - Acute (SIQ - Acute)
The SIQ - Acute assesses the subjective experience of the process of regaining alertness after waking from a sleep episode. Scores range from -66 to +66, higher scores indicating greater difficulty in regaining normal levels of alertness.
Measured: Four mornings, each morning a week apart, spanning one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Oct 2021
- Primary completion29 Jan 2022
- Study completion29 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrusive ThoughtStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psychiatric University Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508166
- Sponsor's protocol ID
- TRAUMA-PROPHYLAXIS
- Acronym
- TRAUMA-PRO
- Status last verified
- Oct 2022
- First submitted
- 31 Jul 2020
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Prevention of Post-traumatic Intrusions in Healthy Volunteers - Towards a Post-exposition Prophylaxis for Post-traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT04508166
- Acronym / sponsor ID
- TRAUMA-PRO / TRAUMA-PROPHYLAXIS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Psychiatric University Hospital, ZurichUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 29 Jan 2022 (actual)
- Study completion
- 29 Jan 2022 (actual)
- First posted
- 11 Aug 2020 (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.
In this study, we investigate the role that deep sleep plays in the prevention of posttraumatic stress disorder after someone has been exposed to a trauma by boosting deep sleep with two drug conditions compared to placebo condition. Each volunteer in the study goes through all three conditions. The quantity of intrusive memories of the trauma will be compared between the three conditions.
Detailed description
The present study seeks to investigate the potential to pharmacologically modulate slow-wave sleep in the acute aftermath of an experimentally-induced trauma in the interest of developing a secondary prevention of posttraumatic stress disorder. The effects of a GABAergic compound will be compared with that of a noradrenergic compound. Memory, sleep and stress-related immune response factors will be quantified and compared across drug conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: Dexmedetomidine, Drug: Placebo, Behavioral: Experimental Model Trauma FilmSublingual dose of dexmedetomidine |
| Gamma-hydroxybutyrate | Active comparator | Drug: Gamma-Hydroxybutyrate, Drug: Placebo, Behavioral: Experimental Model Trauma FilmOral dose of gamma-hydroxybutyrate |
| Placebo | Placebo comparator | Drug: Dexmedetomidine, Drug: Placebo, Behavioral: Experimental Model Trauma FilmOral (saline) and sublingual (orodispersible tablet) doses |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Speaks and understands German
- BMI 18.5 -< 25
- Non-smoker status
- Habitual 5 or fewer alcoholic beverages / week
- Habitual 3 or fewer caffeinated beverages / day
Key exclusion criteria (11 listed)
- Travel across 3 or more time zones within 3 months of study start
- Habitual napping
- Extreme chronotype, determined by Morningness-Eveningness Questionnaire
- History of or presence of a trauma- or stressor-related disorder
- History of or presence of neurological disorder, psychiatric disorder or head injury
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 |
|---|---|---|
| DexmedetomidineAlso: DexdorVolunteers receive a single dose of dexmedetomidine sublingually at scheduled bedrest in the sleep laboratory | Drug | Dexmedetomidine, Placebo |
| Gamma-HydroxybutyrateAlso: XyremVolunteers receive a single oral dose of gamma-hydroxybutyrate at scheduled bedrest in the sleep laboratory | Drug | Gamma-hydroxybutyrate |
| PlaceboVolunteers receive an oral (saline) or sublingual (orodispersible tablet) at scheduled bedrest in the sleep laboratory | Drug | Dexmedetomidine, Gamma-hydroxybutyrate, Placebo |
| Experimental Model Trauma FilmEach volunteer views experimental model trauma film before scheduled bedrest in the sleep laboratory. This video is ca. 15 minutes in duration and is composed of short (a few seconds to a few minutes) individual and unrelated scenes of violent death and injury of varying description. Six versions of the film without re-occurring scenes will be presented in balanced order across drug order conditions. | Behavioural | Dexmedetomidine, Gamma-hydroxybutyrate, Placebo |
Primary outcome
Frequency of intrusive memories
Time frame: Three weeks
The number of intrusive memories of the experimental model trauma film experienced. The number of intrusive memories will be recorded in a diary by participants.
Emotional valence of intrusive memories
Time frame: Three weeks
The emotional valence will be recorded in a diary after experiencing an intrusive memory in an integer scale. The integer scale will range from 1 to 10, where 1 indicates the lowest and 10 indicates the highest.
Personal significance of intrusive memories
Time frame: Three weeks
Personal significance of intrusive memories will be recorded in a diary after experiencing an intrusive memory in an integer scale. The integer scale will range from 1 to 10, where 1 indicates the lowest and 10 indicates the highest.
Oscillatory delta power in the sleep electroencephalogram (EEG) during non rapid eye movement (REM) sleep stages N2 and N3
Time frame: Four nights, each night a week apart, spanning one month
Power in units microvolts squared will be quantified by fast Fourier transform in 4 second segment length in EEG sleep recordings in the delta frequency bin (0.5 - 4.5 Hz).Higher value of delta power indicates greater homeostatic sleep pressure, i.e., the feeling of need for sleep.
Oscillatory theta power in the sleep electroencephalogram (EEG) during non rapid eye movement sleep stages N2 and N3
Time frame: Four nights, each night a week apart, spanning one month
Power in units microvolts squared will be quantified by fast Fourier transform in 4 second segment length in EEG sleep recordings in the theta frequency bin (6 - 9 Hz). Higher value of theta power indicates greater homeostatic sleep pressure, i.e., the feeling of need for sleep.
EEG measures of sleep quality: distribution of N2 and N3 sleep stages.
Time frame: Four nights, each night a week apart, spanning one month
Number of non-REM sleep stages N2 and N3. Greater number of stages N2 and N3 indicate greater homeostatic sleep pressure, i.e., the feeling of need for sleep.
EEG measures of sleep quality: number of arousals
Time frame: Four nights, each night a week apart, spanning one month
Number of arousals Arousals are defined by the American Academy of Sleep Medicine as an increase in EEG frequency at least 3 seconds in NREM sleep in alpha, theta or higher frequencies, excluding spindles; must be accompanied by a minimum of 1 second of muscle activity during REM sleep. The greater the number of arousals indicates the lower homeostatic sleep pressure is in healthy individuals. Normal number of arousals for a healthy adult is ca. 80 per 8 hour sleep episode.
EEG measures of sleep quality: sleep onset latency
Time frame: Four nights, each night a week apart, spanning one month
Sleep onset latency represents elapsed time from intention to initiate sleep until sleep is initiated (defined as the occurrence of any stage of sleep by the AASM). Longer latencies indicate lower homeostatic sleep pressure or some maladaptive, e.g., rumination, stress, or pathological state, e.g., insomnia, posttraumatic stress. Normal latencies for healthy adults is 10 - 20 minutes.
EEG measures of sleep quality: sleep duration
Time frame: Four nights, each night a week apart, spanning one month
Sleep duration represents the duration in time of a sleep episode excluding any intervening stages of waking. Typical sleep duration in the healthy adult population is ca. 8 hours. Extreme sleep durations (<5 or <6 hr or >10 hr) have been associated with cardiometabolic illness risk.
EEG measures of sleep quality: sleep efficiency
Time frame: Four nights, each night a week apart, spanning one month
Sleep efficiency represents how efficient a given sleep episode is and is defined as the duration of sleep (i.e., time spent in all NREM and REM sleep stages) divided b by the total time spent in bed and multiplied by 100. Normal sleep efficiency is 80% or greater. Efficiencies less than this value could raise questions of sleep satiety, maladaptive behavior (e.g., alcohol consumption, caffeine consumption, sleep at incongruent circadian phase) or pathological health conditions (e.g., restless legs, disordered breathing, insomnia).
10 secondary outcomes
Physiological stress: circulating cortisol
Time frame: Four nights, each morning a week apart, spanning one month
Physiological stress: electrocardiogram (ECG) heart rate (HR)
Time frame: Four nights, each night a week apart, spanning one month
Physiological stress: respirometry respiration rate
Time frame: Four nights, each night a week apart, spanning one month
Physiological stress: electrocardiogram (ECG) heart rate variability (HRV)
Time frame: Four nights, each night a week apart, spanning one month
Physiological stress: inflammatory immune factors (cytokines and kynurenines)
Time frame: Four mornings, each morning a week apart, spanning one month
Subjective ratings of mood: Positive and Negative Affect Scale (PANAS)
Time frame: Four nights, each night a week apart, spanning one month
Subjective ratings of mood: State Trait Anxiety Inventory (STAI)
Time frame: Four nights, each night a week apart, spanning one month
Awakening response: cortisol
Time frame: Four mornings, each morning a week apart, spanning one month
Awakening response: Psychomotor Vigilance Task (PVT)
Time frame: Four mornings, each morning a week apart, spanning one month
Sleep inertia Questionnaire - Acute (SIQ - Acute)
Time frame: Four mornings, each morning a week apart, spanning one month
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 4 Oct 2022.
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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 Dexmedetomidine, Gamma-Hydroxybutyrate and Experimental Model Trauma Film in people with Intrusive Thought and Psychological Trauma, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.
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 8 inclusion and 11 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 4 Oct 2022. 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 Switzerland. 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?
Frequency of intrusive memories (time frame: Three weeks). The study lists 10 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 4 Oct 2022.