Prenatal DepressionNCT03927378
Low-dose S-Ketamine and Postpartum Depression in Parturients With Prenatal Depression
A study testing S-ketamine in people with Prenatal Depression and Ketamine, run by Peking University First Hospital at 7 sites in China.
Trial summary
Prenatal depression is an important risk factor of postpartum depression. Low-dose ketamine has been used for depression treatment. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Prenatal Depression, Ketamine, Postpartum Depression
- What is being tested?
- S-ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 364 participants
- Where
- 7 sitesChina
- Study dates
- 19 Jun 2020to 3 Aug 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parturients with age ≥18 years;
- Presence of prenatal depression (EPDS score ≥10);
Who cannot join
- A clear history of mental illness (depression, schizophrenia, etc.) or communication difficulties;
- Severe pregnancy complications, such as severe preeclampsia, placental implantation, HELLP (syndrome hemolytic anemia, elevated liver function and low platelet count) syndrom, placenta previa, and placental abruption;
- American Society of Anesthesiologists classification ≥III;
- Presence of contraindications to ketamine/s-ketamine use, such as refractory hypertension, severe cardiovascular disease (New York Heart Association classification ≥III), and hyperthyroidism.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Beijing Tiantan Hospital
Beijing, Beijing Municipality
Peking University International Hospital
Beijing, Beijing Municipality
Hunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan
Women's Hospital School Of Medicine Zhejiang University
Hanzhou, Zhejiang
Huaian Maternal and Child Health Care Hospital
Huaian, Jiangsu
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu
About this study
Official title: Effects of Low-dose S-Ketamine on Incidence of Postpartum Depression in Parturients With Prenatal Depression: A Randomized, Double-blind, Placebo-controlled Trial
Prenatal depression is an important risk factor of postpartum depression. Low-dose ketamine has been used for depression treatment. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusion after childbirth may reduce the incidence of postpartum depression.
Read the detailed description
Studies have shown that prenatal depression symptoms are important predictors of postpartum depression. Screening of pregnant women's mental condition before giving birth, early identification of pregnant women with symptoms of prenatal depression, and providing appropriate interventions may play an important role in reducing the incidence of postpartum depression. Ketamine is an NMDA-receptor antagonist. In recent years, many studies confirmed that ketamine has a significant antidepressant effect. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. In clinical application, s-ketamine has stronger analgesic effect, better anesthetic effect and lower incidence of adverse psychological reactions. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusions after childbirth may reduce postpartum depression. Evidence is lacking in this regard.
- Conditions
- Prenatal Depression, Ketamine, Postpartum Depression
- Being tested
- S-ketamine, Placebo
- Keywords
- Prenatal Depression, S-Ketamine, 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.
S-ketamineDrug
Also called S-ketamine hydrochloride
S-ketamine (0.2 mg/kg in 20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
PlaceboDrug
Also called Normal saline
Placebo (20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
| Study group | Role | What they receive |
|---|---|---|
| S-katamine group | Experimental | For women in this group, study drug (s-ketamine 0.2 mg/kg in 20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. Women will be monitored for 60 minutes and then sent back to the ward. Receives: Drug: S-ketamine |
| Placebo group | Placebo comparator | For women in this group, study drug (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. Women will be monitored for 60 minutes and then sent back to the ward. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of depression at 42 days after childbirth.
PDepression at 42 days postpartum will be diagnosed by psychiatrists according to the Mini-International Neuropsychiatric Interview (MINI)-6.0.
Measured: At 42 days after childbirth.
Secondary outcomes (8)
Maternal depression score at 7 days postpartum.
Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a telephone interview.
Measured: At 7 days after childbirth.
Maternal depression score at 42 days postpartum.
Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.
Measured: At 42 days after childbirth.
Maternal depression severity at 42 days postpartum.
Maternal depression severity will be assessed with the Hamilton Depression Scale-17
Measured: At 42 days after childbirth.
Intensity of pain at 1, 7, and 42 days postpartum.
Intensity of pain will be assessed with the numeric rating scale (a 11-point scale where 0=no pain and 10=the worst pain).
Measured: At 1, 7, and 42 days after childbirth.
Maternal breast feeding at 1, 7, and 42 days postpartum.
The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.
Measured: At 1, 7, and 42 days after childbirth.
Length of hospital stay after giving birth.
Length of hospital stay after giving birth.
Measured: Up to 30 days after giving birth.
Incidence of maternal complications within 42 days postpartum.
Maternal complications are defined as those that are harmful to maternal health and require medical intervention.
Measured: Up to 42 days after giving birth.
Incidence of neonatal diseases within 42 days.
Neonatal diseases are defined as those that require medical intervention.
Measured: Up to 42 days after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start19 Jun 2020
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Prenatal DepressionStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University International Hospital, Hunan Provincial Maternal and Child Health Care Hospital, Nanjing Medical University, Women's Hospital School Of Medicine Zhejiang University
- Responsible party
- Principal investigator, Dong-Xin Wang, Peking University First Hospital
- Investigators
- Dong-Xin Wang, MD, PhD, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927378
- Sponsor's protocol ID
- 2018[224]
- Status last verified
- Apr 2023
- First submitted
- 23 Apr 2019
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nonacs R, Cohen LS. Postpartum mood disorders: diagnosis and treatment guidelines. J Clin Psychiatry. 1998;59 Suppl 2:34-40.
PubMed 9559758Kim S, Soeken TA, Cromer SJ, Martinez SR, Hardy LR, Strathearn L. Oxytocin and postpartum depression: delivering on what's known and what's not. Brain Res. 2014 Sep 11;1580:219-32. doi: 10.1016/j.brainres.2013.11.009. Epub 2013 Nov 14.
PubMed 24239932Giallo R, Pilkington P, McDonald E, Gartland D, Woolhouse H, Brown S. Physical, sexual and social health factors associated with the trajectories of maternal depressive symptoms from pregnancy to 4 years postpartum. Soc Psychiatry Psychiatr Epidemiol. 2017 Jul;52(7):815-828. doi: 10.1007/s00127-017-1387-8. Epub 2017 Apr 27.
PubMed 28451700Giallo R, Cooklin A, Nicholson JM. Risk factors associated with trajectories of mothers' depressive symptoms across the early parenting period: an Australian population-based longitudinal study. Arch Womens Ment Health. 2014 Apr;17(2):115-25. doi: 10.1007/s00737-014-0411-1. Epub 2014 Jan 15.
PubMed 24424796Sutter-Dallay AL, Cosnefroy O, Glatigny-Dallay E, Verdoux H, Rascle N. Evolution of perinatal depressive symptoms from pregnancy to two years postpartum in a low-risk sample: the MATQUID cohort. J Affect Disord. 2012 Jun;139(1):23-9. doi: 10.1016/j.jad.2011.08.018. Epub 2012 Mar 11.
PubMed 22410506McCall-Hosenfeld JS, Phiri K, Schaefer E, Zhu J, Kjerulff K. Trajectories of Depressive Symptoms Throughout the Peri- and Postpartum Period: Results from the First Baby Study. J Womens Health (Larchmt). 2016 Nov;25(11):1112-1121. doi: 10.1089/jwh.2015.5310. Epub 2016 Jun 16.
PubMed 27310295Tsai R, Schaffir J. Effect of depot medroxyprogesterone acetate on postpartum depression. Contraception. 2010 Aug;82(2):174-7. doi: 10.1016/j.contraception.2010.03.004. Epub 2010 Apr 13.
PubMed 20654759Ding T, Wang DX, Qu Y, Chen Q, Zhu SN. Epidural labor analgesia is associated with a decreased risk of postpartum depression: a prospective cohort study. Anesth Analg. 2014 Aug;119(2):383-392. doi: 10.1213/ANE.0000000000000107.
PubMed 24797120Quevedo LA, Silva RA, Godoy R, Jansen K, Matos MB, Tavares Pinheiro KA, Pinheiro RT. The impact of maternal post-partum depression on the language development of children at 12 months. Child Care Health Dev. 2012 May;38(3):420-4. doi: 10.1111/j.1365-2214.2011.01251.x. Epub 2011 Jun 8.
PubMed 21651606Parsons CE, Young KS, Rochat TJ, Kringelbach ML, Stein A. Postnatal depression and its effects on child development: a review of evidence from low- and middle-income countries. Br Med Bull. 2012;101:57-79. doi: 10.1093/bmb/ldr047. Epub 2011 Nov 29.
PubMed 22130907Weitzman M, Rosenthal DG, Liu YH. Paternal depressive symptoms and child behavioral or emotional problems in the United States. Pediatrics. 2011 Dec;128(6):1126-34. doi: 10.1542/peds.2010-3034. Epub 2011 Nov 7.
PubMed 22065273Demontigny F, Girard ME, Lacharite C, Dubeau D, Devault A. Psychosocial factors associated with paternal postnatal depression. J Affect Disord. 2013 Aug 15;150(1):44-9. doi: 10.1016/j.jad.2013.01.048. Epub 2013 Mar 13.
PubMed 23489392Dietz LJ, Jennings KD, Kelley SA, Marshal M. Maternal depression, paternal psychopathology, and toddlers' behavior problems. J Clin Child Adolesc Psychol. 2009 Jan;38(1):48-61. doi: 10.1080/15374410802575362.
PubMed 19130357Pawlby S, Sharp D, Hay D, O'Keane V. Postnatal depression and child outcome at 11 years: the importance of accurate diagnosis. J Affect Disord. 2008 Apr;107(1-3):241-5. doi: 10.1016/j.jad.2007.08.002. Epub 2007 Sep 12.
PubMed 17854906Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for postpartum depression: a synthesis of recent literature. Gen Hosp Psychiatry. 2004 Jul-Aug;26(4):289-95. doi: 10.1016/j.genhosppsych.2004.02.006.
PubMed 15234824
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-dose S-Ketamine on Incidence of Postpartum Depression in Parturients With Prenatal Depression: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT03927378
- Acronym / sponsor ID
- 2018[224]
- Conditions
- Prenatal Depression, Ketamine, Postpartum Depression
- Keywords
- Prenatal Depression, S-Ketamine, Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Peking University International Hospital, Hunan Provincial Maternal and Child Health Care Hospital, Nanjing Medical University, Women's Hospital School Of Medicine Zhejiang University
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 25 Apr 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.
Prenatal depression is an important risk factor of postpartum depression. Low-dose ketamine has been used for depression treatment. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusion after childbirth may reduce the incidence of postpartum depression.
Detailed description
Studies have shown that prenatal depression symptoms are important predictors of postpartum depression. Screening of pregnant women's mental condition before giving birth, early identification of pregnant women with symptoms of prenatal depression, and providing appropriate interventions may play an important role in reducing the incidence of postpartum depression. Ketamine is an NMDA-receptor antagonist. In recent years, many studies confirmed that ketamine has a significant antidepressant effect. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. In clinical application, s-ketamine has stronger analgesic effect, better anesthetic effect and lower incidence of adverse psychological reactions. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusions after childbirth may reduce postpartum depression. Evidence is lacking in this regard.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-katamine group | Experimental | Drug: S-ketamineFor women in this group, study drug (s-ketamine 0.2 mg/kg in 20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. Women will be monitored for 60 minutes and then sent back to the ward. |
| Placebo group | Placebo comparator | Drug: PlaceboFor women in this group, study drug (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. Women will be monitored for 60 minutes and then sent back to the ward. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Parturients with age ≥18 years;
- Presence of prenatal depression (EPDS score ≥10);
Key exclusion criteria (4 listed)
- A clear history of mental illness (depression, schizophrenia, etc.) or communication difficulties;
- Severe pregnancy complications, such as severe preeclampsia, placental implantation, HELLP (syndrome hemolytic anemia, elevated liver function and low platelet count) syndrom, placenta previa, and placental abruption;
- American Society of Anesthesiologists classification ≥III;
- Presence of contraindications to ketamine/s-ketamine use, such as refractory hypertension, severe cardiovascular disease (New York Heart Association classification ≥III), and hyperthyroidism.
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 |
|---|---|---|
| S-ketamineAlso: S-ketamine hydrochlorideS-ketamine (0.2 mg/kg in 20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth. | Drug | S-katamine group |
| PlaceboAlso: Normal salinePlacebo (20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth. | Drug | Placebo group |
Primary outcome
The incidence of depression at 42 days after childbirth.
Time frame: At 42 days after childbirth.
PDepression at 42 days postpartum will be diagnosed by psychiatrists according to the Mini-International Neuropsychiatric Interview (MINI)-6.0.
8 secondary outcomes
Maternal depression score at 7 days postpartum.
Time frame: At 7 days after childbirth.
Maternal depression score at 42 days postpartum.
Time frame: At 42 days after childbirth.
Maternal depression severity at 42 days postpartum.
Time frame: At 42 days after childbirth.
Intensity of pain at 1, 7, and 42 days postpartum.
Time frame: At 1, 7, and 42 days after childbirth.
Maternal breast feeding at 1, 7, and 42 days postpartum.
Time frame: At 1, 7, and 42 days after childbirth.
Length of hospital stay after giving birth.
Time frame: Up to 30 days after giving birth.
Incidence of maternal complications within 42 days postpartum.
Time frame: Up to 42 days after giving birth.
Incidence of neonatal diseases within 42 days.
Time frame: Up to 42 days after birth.
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 Apr 2023.
- Background: PubMed 9559758Nonacs R, Cohen LS. Postpartum mood disorders: diagnosis and treatment guidelines. J Clin Psychiatry. 1998;59 Suppl 2:34-40.
- Background: PubMed 24239932Kim S, Soeken TA, Cromer SJ, Martinez SR, Hardy LR, Strathearn L. Oxytocin and postpartum depression: delivering on what's known and what's not. Brain Res. 2014 Sep 11;1580:219-32. doi: 10.1016/j.brainres.2013.11.009. Epub 2013 Nov 14.
- Background: PubMed 28451700Giallo R, Pilkington P, McDonald E, Gartland D, Woolhouse H, Brown S. Physical, sexual and social health factors associated with the trajectories of maternal depressive symptoms from pregnancy to 4 years postpartum. Soc Psychiatry Psychiatr Epidemiol. 2017 Jul;52(7):815-828. doi: 10.1007/s00127-017-1387-8. Epub 2017 Apr 27.
- Background: PubMed 24424796Giallo R, Cooklin A, Nicholson JM. Risk factors associated with trajectories of mothers' depressive symptoms across the early parenting period: an Australian population-based longitudinal study. Arch Womens Ment Health. 2014 Apr;17(2):115-25. doi: 10.1007/s00737-014-0411-1. Epub 2014 Jan 15.
- Background: PubMed 22410506Sutter-Dallay AL, Cosnefroy O, Glatigny-Dallay E, Verdoux H, Rascle N. Evolution of perinatal depressive symptoms from pregnancy to two years postpartum in a low-risk sample: the MATQUID cohort. J Affect Disord. 2012 Jun;139(1):23-9. doi: 10.1016/j.jad.2011.08.018. Epub 2012 Mar 11.
- Background: PubMed 27310295McCall-Hosenfeld JS, Phiri K, Schaefer E, Zhu J, Kjerulff K. Trajectories of Depressive Symptoms Throughout the Peri- and Postpartum Period: Results from the First Baby Study. J Womens Health (Larchmt). 2016 Nov;25(11):1112-1121. doi: 10.1089/jwh.2015.5310. Epub 2016 Jun 16.
- Background: PubMed 20654759Tsai R, Schaffir J. Effect of depot medroxyprogesterone acetate on postpartum depression. Contraception. 2010 Aug;82(2):174-7. doi: 10.1016/j.contraception.2010.03.004. Epub 2010 Apr 13.
- Background: PubMed 24797120Ding T, Wang DX, Qu Y, Chen Q, Zhu SN. Epidural labor analgesia is associated with a decreased risk of postpartum depression: a prospective cohort study. Anesth Analg. 2014 Aug;119(2):383-392. doi: 10.1213/ANE.0000000000000107.
- Background: PubMed 21651606Quevedo LA, Silva RA, Godoy R, Jansen K, Matos MB, Tavares Pinheiro KA, Pinheiro RT. The impact of maternal post-partum depression on the language development of children at 12 months. Child Care Health Dev. 2012 May;38(3):420-4. doi: 10.1111/j.1365-2214.2011.01251.x. Epub 2011 Jun 8.
- Background: PubMed 22130907Parsons CE, Young KS, Rochat TJ, Kringelbach ML, Stein A. Postnatal depression and its effects on child development: a review of evidence from low- and middle-income countries. Br Med Bull. 2012;101:57-79. doi: 10.1093/bmb/ldr047. Epub 2011 Nov 29.
- Background: PubMed 22065273Weitzman M, Rosenthal DG, Liu YH. Paternal depressive symptoms and child behavioral or emotional problems in the United States. Pediatrics. 2011 Dec;128(6):1126-34. doi: 10.1542/peds.2010-3034. Epub 2011 Nov 7.
- Background: PubMed 23489392Demontigny F, Girard ME, Lacharite C, Dubeau D, Devault A. Psychosocial factors associated with paternal postnatal depression. J Affect Disord. 2013 Aug 15;150(1):44-9. doi: 10.1016/j.jad.2013.01.048. Epub 2013 Mar 13.
- 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.
Dong-Xin Wang, MD, PhD principal investigator
Peking University First Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-ketamine in people with Prenatal Depression and Ketamine, run by Peking University First Hospital at 7 sites in China.
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 4 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 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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?
The incidence of depression at 42 days after childbirth. (time frame: At 42 days after childbirth.). 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 NCT03927378, which also lists 31 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 4 Apr 2023.