Postpartum DepressionPhase 4EEPDNCT05229913
Effects of Esketamine on Postpartum Depression
A Phase 4 study testing Esketamine is not added, Esketamine 0.2mg/kg and Esketamine 0.4mg/kg in people with Postpartum Depression, run by Qinghai University.
Trial summary
Different concentrations of Esketamine were used after cesarean section. Through the evaluation of postoperative psychological status and analgesic effect, the optimal dosage of Esketamine to exert the effects of depression and analgesia was analyzed. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- Esketamine is not added, Esketamine 0.2mg/kg and Esketamine 0.4mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2022to 30 Jun 2023
- Phase
- Phase 4
- 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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All participating patients signed an informed consent form;
- Age 25-35 years old;
- BMI≤35kg/m2;
- ASA classification I or II;
- Ultrasound showed a single pregnancy in the uterus Fetus, placental maturity grade Ⅱ+
Who cannot join
- Unable or unwilling to sign the consent form, or unable to follow the research procedures;
- History of thyroid disease;
- A history of local anesthetic allergy;
- A history of addiction or abuse to opioids and ketamine;
- Preoperative mental illness; severe eclampsia;
- Abnormal ECG, hypertension and severe heart Medical history
- There are other contraindications to the use of esketamine
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Different Concentrations of Esketamine on Postpartum Depression After Cesarean Section
Different concentrations of Esketamine were used after cesarean section. Through the evaluation of postoperative psychological status and analgesic effect, the optimal dosage of Esketamine to exert the effects of depression and analgesia was analyzed.
Read the detailed description
A total of 500 cases of pregnant women undergoing cesarean section under spinal anesthesia in Qinghai Red Cross Hospital from February 2022 to September 2022 were selected. General information of the patients were recorded, such as age, height, weight, BMI, nationality, education level, previous history, surgical history, allergy history, spouse status, fertility history and drug use status, and ASA classification was performed. Preliminarily determine whether it meets the inclusion and exclusion criteria. If it can be included in the study, the purpose, method and possible complications of the study should be fully explained to the patients and their families, as well as the significance and value of the study. Informed consent should be signed after the informed consent of the patients and their families. Patients were divided into 5 groups (n=100) according to random number method, including control group (GROUP C) and different concentrations of Esketamine dose group (group E0.2, group E0.4, group E0.6, group E0.8).
Before surgery, the puerpera were fasted for 8 hours and abstained from drinking for 4 hours. After entering the operating room, ECG monitoring and continuous oxygen inhalation by mask (2.0-3.0 L/min) were performed, and the upper limb vein channels were opened. Subarachnoid puncture was performed in L2-3 or L3-4 gaps. After the cerebrospinal fluid flows out, give 0.5% ropivacaine 10-12mg. After the subarachnoid block was successful, the epidural catheter was indurated for 4cm. The supine position was restored, and when necessary, the pregnant women were changed 30° to the left, and the supine hypotension syndrome occurred (SBP≤90mmHg or decrease ≥mmHg), 1-2mg methoxide was injected intravenously. The operation was started after the level of anesthesia was satisfied (maintain anesthesia level<T6). Postoperative intravenous controlled analgesia (PCIA). The formula of PCIA in different groups.The unified total amount of PCIA is 100mL, the background infusion rate is 2mL /h, the PCA dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery.
Using SPSS26.0 statistical software. The measurement data is expressed as x±s, the comparison between groups is performed by one-way analysis of variance, the further pairwise comparison is performed by t test, and the comparison of different time points within the group is performed by repeated measures analysis of variance; the comparison of count data is performed by the chi-square test. P<0.05 indicates that the difference is statistically significant.
- Conditions
- Postpartum Depression
- Being tested
- Esketamine is not added, Esketamine 0.2mg/kg, Esketamine 0.4mg/kg, Esketamine 0.6mg/kg, Esketamine 0.8mg/kg
- Keywords
- Esketamine, Postpartum Depression
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine is not addedDrug
Postoperative intravenous analgesia pump formula：Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg
Esketamine 0.2mg/kgDrug
Postoperative intravenous analgesia pump formula：Esketamine 0.2mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg.
Esketamine 0.4mg/kgDrug
Postoperative intravenous analgesia pump formula：Esketamine 0.4mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200ml.
Esketamine 0.6mg/kgDrug
Postoperative intravenous analgesia pump formula：Esketamine 0.6mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg.
Esketamine 0.8mg/kgDrug
Postoperative intravenous analgesia pump formula：Esketamine 0.8mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg.
| Study group | Role | What they receive |
|---|---|---|
| The control group （Esketamine is not added） | Placebo comparator | Postoperative intravenous analgesia pump formula：Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery. Receives: Drug: Esketamine is not added |
| Esketamine experimental group(E0.2) | Experimental | Postoperative intravenous analgesia pump formula：Esketamine 0.2mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery. Receives: Drug: Esketamine 0.2mg/kg |
| Esketamine experimental group (E0.4) | Experimental | Postoperative intravenous analgesia pump formula：Esketamine 0.4mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery. Receives: Drug: Esketamine 0.4mg/kg |
| Esketamine experimental group (E0.6) | Experimental | Postoperative intravenous analgesia pump formula：Esketamine 0.6mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery. Receives: Drug: Esketamine 0.6mg/kg |
| Esketamine experimental group (E0.8) | Experimental | Postoperative intravenous analgesia pump formula：Esketamine 0.8mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery. Receives: Drug: Esketamine 0.8mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postpartum Depression Scale (EPDS) score
The Edinburgh Postpartum Depression Scale includes 10 items. According to the severity of symptoms, each item is divided into 4 levels (0, 1, 2, 3). The patient may be depressed when the total score is 10-12 points, and postpartum depression can be diagnosed when the total score is greater than 13 points.
Measured: The Edinburgh Postpartum Depression Scale (EPDS) score was performed day 42 after surgery
Secondary outcomes (2)
short-form of McGill Pain Questionnaire (SF-MPQ)
The SF-MPQ consisted of 11 sensory and 4 affective descriptors for pain. All descriptors are used 0~3 to indicate the different degrees of none, light, medium and heavy respectively
Measured: 6hours(T0), 12hours (T1), 24hours (T2), 48hours (T3) after operation
Visual analog scale (VAS) for pain
Patients were asked to circle a number that best represented their pain level using a scale of 0-10, with 0 being no pain and 10 being most severe. 0: painless; 1-3: Mild pain; 4-6: Moderate pain; 7-10: Severe pain
Measured: 6hours (T0), 12hours(T1), 24hours (T2), 48hours (T3) after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start20 Feb 2022 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qinghai University
- Sponsor type
- University, hospital or other
- Collaborators
- Qinghai Red Cross Hospital
- Responsible party
- Principal investigator, Yang Jingmei, Qinghai University
- Investigators
- Wang Xuejun, director, Study director, Department of Anesthesiology, Qinghai Red Cross Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229913
- Sponsor's protocol ID
- JMYang
- Other IDs
- 2019-ZJ-930
- Acronym
- EEPD
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants' basic information, depression and analgesia scores after esketamine use, and incidence of adverse reactions were shared
Publications
Suppa E, Valente A, Catarci S, Zanfini BA, Draisci G. A study of low-dose S-ketamine infusion as "preventive" pain treatment for cesarean section with spinal anesthesia: benefits and side effects. Minerva Anestesiol. 2012 Jul;78(7):774-81. Epub 2012 Feb 29.
PubMed 22374377Krystal JH, Charney DS, Duman RS. A New Rapid-Acting Antidepressant. Cell. 2020 Apr 2;181(1):7. doi: 10.1016/j.cell.2020.02.033.
PubMed 32243798Singh JB, Fedgchin M, Daly E, Xi L, Melman C, De Bruecker G, Tadic A, Sienaert P, Wiegand F, Manji H, Drevets WC, Van Nueten L. Intravenous Esketamine in Adult Treatment-Resistant Depression: A Double-Blind, Double-Randomization, Placebo-Controlled Study. Biol Psychiatry. 2016 Sep 15;80(6):424-431. doi: 10.1016/j.biopsych.2015.10.018. Epub 2015 Nov 3.
PubMed 26707087O'Hara MW, McCabe JE. Postpartum depression: current status and future directions. Annu Rev Clin Psychol. 2013;9:379-407. doi: 10.1146/annurev-clinpsy-050212-185612. Epub 2013 Feb 1.
PubMed 23394227
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Concentrations of Esketamine on Postpartum Depression After Cesarean Section
- ClinicalTrials.gov ID
- NCT05229913
- Acronym / sponsor ID
- EEPD / JMYang
- Conditions
- Postpartum Depression
- Keywords
- Esketamine, Postpartum Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Qinghai UniversityUniversity, hospital or other
- Collaborators
- Qinghai Red Cross Hospital
- Study start
- 20 Feb 2022 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 8 Feb 2022 (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.
Different concentrations of Esketamine were used after cesarean section. Through the evaluation of postoperative psychological status and analgesic effect, the optimal dosage of Esketamine to exert the effects of depression and analgesia was analyzed.
Detailed description
A total of 500 cases of pregnant women undergoing cesarean section under spinal anesthesia in Qinghai Red Cross Hospital from February 2022 to September 2022 were selected. General information of the patients were recorded, such as age, height, weight, BMI, nationality, education level, previous history, surgical history, allergy history, spouse status, fertility history and drug use status, and ASA classification was performed. Preliminarily determine whether it meets the inclusion and exclusion criteria. If it can be included in the study, the purpose, method and possible complications of the study should be fully explained to the patients and their families, as well as the significance and value of the study. Informed consent should be signed after the informed consent of the patients and their families. Patients were divided into 5 groups (n=100) according to random number method, including control group (GROUP C) and different concentrations of Esketamine dose group (group E0.2, group E0.4, group E0.6, group E0.8).
Before surgery, the puerpera were fasted for 8 hours and abstained from drinking for 4 hours. After entering the operating room, ECG monitoring and continuous oxygen inhalation by mask (2.0-3.0 L/min) were performed, and the upper limb vein channels were opened. Subarachnoid puncture was performed in L2-3 or L3-4 gaps. After the cerebrospinal fluid flows out, give 0.5% ropivacaine 10-12mg. After the subarachnoid block was successful, the epidural catheter was indurated for 4cm. The supine position was restored, and when necessary, the pregnant women were changed 30° to the left, and the supine hypotension syndrome occurred (SBP≤90mmHg or decrease ≥mmHg), 1-2mg methoxide was injected intravenously. The operation was started after the level of anesthesia was satisfied (maintain anesthesia level<T6). Postoperative intravenous controlled analgesia (PCIA). The formula of PCIA in different groups.The unified total amount of PCIA is 100mL, the background infusion rate is 2mL /h, the PCA dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery.
Using SPSS26.0 statistical software. The measurement data is expressed as x±s, the comparison between groups is performed by one-way analysis of variance, the further pairwise comparison is performed by t test, and the comparison of different time points within the group is performed by repeated measures analysis of variance; the comparison of count data is performed by the chi-square test. P<0.05 indicates that the difference is statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| The control group （Esketamine is not added） | Placebo comparator | Drug: Esketamine is not addedPostoperative intravenous analgesia pump formula：Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery. |
| Esketamine experimental group(E0.2) | Experimental | Drug: Esketamine 0.2mg/kgPostoperative intravenous analgesia pump formula：Esketamine 0.2mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery. |
| Esketamine experimental group (E0.4) | Experimental | Drug: Esketamine 0.4mg/kgPostoperative intravenous analgesia pump formula：Esketamine 0.4mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery. |
| Esketamine experimental group (E0.6) | Experimental | Drug: Esketamine 0.6mg/kgPostoperative intravenous analgesia pump formula：Esketamine 0.6mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery. |
| Esketamine experimental group (E0.8) | Experimental | Drug: Esketamine 0.8mg/kgPostoperative intravenous analgesia pump formula：Esketamine 0.8mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg The intravenous analgesic pump in each group was supplemented with normal saline and matched to 100 ml, the background infusion rate is 2ml/h, the Self-controlled intravenous analgesia pressing once dose is 1ml, the locking time is 20min, and the analgesia lasted until 48h after surgery. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All participating patients signed an informed consent form;
- Age 25-35 years old;
- BMI≤35kg/m2;
- ASA classification I or II;
- Ultrasound showed a single pregnancy in the uterus Fetus, placental maturity grade Ⅱ+
Key exclusion criteria (7 listed)
- Unable or unwilling to sign the consent form, or unable to follow the research procedures;
- History of thyroid disease;
- A history of local anesthetic allergy;
- A history of addiction or abuse to opioids and ketamine;
- Preoperative mental illness; severe eclampsia;
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 |
|---|---|---|
| Esketamine is not addedPostoperative intravenous analgesia pump formula：Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg | Drug | The control group （Esketamine is not added） |
| Esketamine 0.2mg/kgPostoperative intravenous analgesia pump formula：Esketamine 0.2mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg. | Drug | Esketamine experimental group(E0.2) |
| Esketamine 0.4mg/kgPostoperative intravenous analgesia pump formula：Esketamine 0.4mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200ml. | Drug | Esketamine experimental group (E0.4) |
| Esketamine 0.6mg/kgPostoperative intravenous analgesia pump formula：Esketamine 0.6mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg. | Drug | Esketamine experimental group (E0.6) |
| Esketamine 0.8mg/kgPostoperative intravenous analgesia pump formula：Esketamine 0.8mg/kg + Sufentanil 1ug/kg+ Flurbiprofen Axetil 200mg. | Drug | Esketamine experimental group (E0.8) |
Primary outcome
Edinburgh Postpartum Depression Scale (EPDS) score
Time frame: The Edinburgh Postpartum Depression Scale (EPDS) score was performed day 42 after surgery
The Edinburgh Postpartum Depression Scale includes 10 items. According to the severity of symptoms, each item is divided into 4 levels (0, 1, 2, 3). The patient may be depressed when the total score is 10-12 points, and postpartum depression can be diagnosed when the total score is greater than 13 points.
2 secondary outcomes
short-form of McGill Pain Questionnaire (SF-MPQ)
Time frame: 6hours(T0), 12hours (T1), 24hours (T2), 48hours (T3) after operation
Visual analog scale (VAS) for pain
Time frame: 6hours (T0), 12hours(T1), 24hours (T2), 48hours (T3) after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Background: PubMed 22374377Suppa E, Valente A, Catarci S, Zanfini BA, Draisci G. A study of low-dose S-ketamine infusion as "preventive" pain treatment for cesarean section with spinal anesthesia: benefits and side effects. Minerva Anestesiol. 2012 Jul;78(7):774-81. Epub 2012 Feb 29.
- Background: PubMed 32243798Krystal JH, Charney DS, Duman RS. A New Rapid-Acting Antidepressant. Cell. 2020 Apr 2;181(1):7. doi: 10.1016/j.cell.2020.02.033.
- Background: PubMed 26707087Singh JB, Fedgchin M, Daly E, Xi L, Melman C, De Bruecker G, Tadic A, Sienaert P, Wiegand F, Manji H, Drevets WC, Van Nueten L. Intravenous Esketamine in Adult Treatment-Resistant Depression: A Double-Blind, Double-Randomization, Placebo-Controlled Study. Biol Psychiatry. 2016 Sep 15;80(6):424-431. doi: 10.1016/j.biopsych.2015.10.018. Epub 2015 Nov 3.
- Results publication: PubMed 23394227O'Hara MW, McCabe JE. Postpartum depression: current status and future directions. Annu Rev Clin Psychol. 2013;9:379-407. doi: 10.1146/annurev-clinpsy-050212-185612. Epub 2013 Feb 1.
- Individual participant dataSharing planned: Yes. Participants' basic information, depression and analgesia scores after esketamine use, and incidence of adverse reactions were shared
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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.
Wang Xuejun, director study director
Department of Anesthesiology, Qinghai Red Cross Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Esketamine is not added, Esketamine 0.2mg/kg and Esketamine 0.4mg/kg in people with Postpartum Depression, run by Qinghai University.
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 7 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: status not confirmed, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Xuejun, director (+86 18997159111, wangxuejunhsz9111@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postpartum Depression Scale (EPDS) score (time frame: The Edinburgh Postpartum Depression Scale (EPDS) score was performed day 42 after surgery). 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 NCT05229913, which also lists 4 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 8 Feb 2022.