Surgery With General AnesthesiaNCT06783842
Perioperative Depression, an Observational Cohort Study
An observational study of Surgery With General Anesthesia and Depression - Major Depressive Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This observational cohort study studies two aspects of perioperative depression. First, it examines the postoperative morbidity and mortality among patients with preoperative depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery With General Anesthesia, Depression - Major Depressive Disorder
- How many people
- 700,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2025to Jan 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This cohort is fully comprised of adult patients undergoing surgery at Karolinska University Hospital in Solna or in Huddinge
Who may be able to join
- Adult patients (18 years or older) undergoing surgery at Karolinska University Hospital in Solna or in Huddinge
Who cannot join
- Patients under the age of 18.
Trial locations and contacts
1 site in 1 country.
About this study
This observational cohort study studies two aspects of perioperative depression.
First, it examines the postoperative morbidity and mortality among patients with preoperative depression.
Secondly, in a subset of patients without signs of preoperative depression, the investigators describe the riskfactors for development of de-novo postoperative depression.
Read the detailed description
BACKGROUND With over 300 million surgeries performed yearly, the impact of perioperative morbidity weighs heavily on society[1]. Multiple studies have highlighted cardiac-[1], renal-[2], pulmonary-[3] and neurological complications[4] as well as other compound metrics of outcome.[5] Postoperative complications, if survived, sometimes result in major impact on function and quality of life.[6] Whilst somatic complications after major surgery are being increasingly investigated, the research field has scarce data on psychological outcomes such as postoperative depression. Most studies use specific surgical cohorts. These include studies of meningioma surgery[7] and glioma patients[8]; both with elevated risk of postoperative depression. In contrast, no significant difference in antidepressant use was found after vestibular schwannoma surgery.[9] When comparing spinal surgery to coronary artery bypass grafting, hysterectomy, cholecystectomy, chronic obstructive pulmonary disease, congestive heart failure exacerbation, and uncomplicated vaginal delivery, the former had the highest risk for postoperative depression.[10] Etiology of major depressive disorder (MDD) is poorly understood, and diagnosis is difficult.[11, 12] Many who experience a first episode of MDD will go on to suffer from recurrent episodes.[13, 14] When compared to equally disabling somatic disorders treatment for depression is less prevalent, indicating under-treatment of the condition.[15] Additionally, individuals with MDD are at elevated risk of cardiovascular disease and all cause-mortality.[16]
HYPOTHESIS The investigators hypothesize that surgery is a stressful event, potentially triggering depression. The investigators further hypothesize that in selected high-risk patients, postoperative new-onset depression is more common and potentially avoidable.
METHODS The investigators plan to use perioperative data from the surgical planning tool, Orbit. The Orbit cohort at Karolinska University Hospital in Solna and in Huddinge, two separate large university hospitals includes Swedish personal identity number (PIN), patient demographics, American Society of Anesthesiologists (ASA) physical status classification, type, date and duration of anesthesia and surgery. NOMESCO classification can be used to subgroup surgical procedures into sixteen categories; neuro, endocrine, ophthalmic, ear, nose and throat, oral and maxillofacial, cardiac, vascular, thoracic, breast, gastrointestinal, urologic, gynecologic, obstetric, orthopedic, dermatologic and minor surgery. The Orbit cohort is cross-matched with electronical medical records (EMR) allowing us to characterize the patients in the cohort based on pre- and postoperative ICD-codes (diagnoses, co-morbid conditions) and pre- and postoperative ATC-codes (medications). Hospital length of stay, readmissions and dates of death can also be retrieved from the EMR.
By merging Orbit data with EMR-data as described above it effectively allows us to investigate short- and long-term outcome for patients developing (new-onset) postoperative depression; this can be achieved by removing patients with depression diagnoses (using ICD-codes from the EMR) and/or patients with collected antidepressants (using ATC-codes from the EMR) in the years prior to surgery. What is the short- and long-term mortality for these patients? How do they far in terms of overall morbidity and health care utilization? The investigators can also characterize the short- and long-term outcome for patients with preoperative depression, focusing specifically on the patients excluded in the study two. How do these patients fare in term of risks for mortality, morbidity and health care utilization?
- Keywords
- Perioperative medicine, Perioperative depression, Observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Surgical cohort | Adult patients undergoing surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death after index surgery, time frames (see below)
Measured: 30/60/90/365-day mortality
Days At Home Alive at 30 days after surgery
DAH-30 is calculated using mortality and hospitalisation data from the date of the index surgery (= Day 0). For example, if a patient died on day 2 after their surgery whilst still an inpatient, they would be assigned zero (0) days at home; if a patient was discharged from hospital on Day 6 after surgery but was subsequently re-admitted for 4 days before their second hospital discharge, then they would be assigned a DAH-30 value of 20. If a patient has complications and spends 16 days in hospital, and then is transferred to a nursing facility for rehabilitation, and spend 24 days there before finally being discharged to their own home, they would be assigned a DAH-30 value of zero (0), even though 30-16-24 = -10 because the minimum value of DAH-30 should be zero. If a patient dies within 30 days of surgery, irrespective of whether they have spent some time at home, DAH-30 will be scored as zero (0).
That is, DAH-30 captures the impact of any complications after surgery.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Surgery With General AnesthesiaStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Bell, Karolinska Institutet
- Investigators
- Max Bell, MD, Phd, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783842
- Sponsor's protocol ID
- 2024-01664-01 Periopdepr
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data, may be shared to researchers that provide a methodological sound proposal
Publications
Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet. 2015 Apr 27;385 Suppl 2:S11. doi: 10.1016/S0140-6736(15)60806-6. Epub 2015 Apr 26.
PubMed 26313057Prowle JR, Forni LG, Bell M, Chew MS, Edwards M, Grams ME, Grocott MPW, Liu KD, McIlroy D, Murray PT, Ostermann M, Zarbock A, Bagshaw SM, Bartz R, Bell S, Bihorac A, Gan TJ, Hobson CE, Joannidis M, Koyner JL, Levett DZH, Mehta RL, Miller TE, Mythen MG, Nadim MK, Pearse RM, Rimmele T, Ronco C, Shaw AD, Kellum JA. Postoperative acute kidney injury in adult non-cardiac surgery: joint consensus report of the Acute Disease Quality Initiative and PeriOperative Quality Initiative. Nat Rev Nephrol. 2021 Sep;17(9):605-618. doi: 10.1038/s41581-021-00418-2. Epub 2021 May 11.
PubMed 33976395Fernandez-Bustamante A, Frendl G, Sprung J, Kor DJ, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery: A Multicenter Study by the Perioperative Research Network Investigators. JAMA Surg. 2017 Feb 1;152(2):157-166. doi: 10.1001/jamasurg.2016.4065.
PubMed 27829093Platzbecker K, Grabitz SD, Raub D, Rudolph MI, Friedrich S, Vinzant N, Kurth T, Weimar C, Bhatt DL, Nozari A, Houle TT, Xu X, Eikermann M. Development and external validation of a prognostic model for ischaemic stroke after surgery. Br J Anaesth. 2021 Nov;127(5):713-721. doi: 10.1016/j.bja.2021.05.035. Epub 2021 Jul 22.
PubMed 34303492Bell M, Eriksson LI, Svensson T, Hallqvist L, Granath F, Reilly J, Myles PS. Days at Home after Surgery: An Integrated and Efficient Outcome Measure for Clinical Trials and Quality Assurance. EClinicalMedicine. 2019 Apr 27;11:18-26. doi: 10.1016/j.eclinm.2019.04.011. eCollection 2019 May-Jun.
PubMed 31317130Grocott MP, Pearse RM. Prognostic studies of perioperative risk: robust methodology is needed. Br J Anaesth. 2010 Sep;105(3):243-5. doi: 10.1093/bja/aeq207. No abstract available.
PubMed 20716567Thurin E, Ryden I, Skoglund T, Smits A, Gulati S, Hesselager G, Bartek J Jr, Henriksson R, Salvesen O, Jakola AS. Impact of meningioma surgery on use of antiepileptic, antidepressant, and sedative drugs: A Swedish nationwide matched cohort study. Cancer Med. 2021 May;10(9):2967-2977. doi: 10.1002/cam4.3868. Epub 2021 Mar 26.
PubMed 33773085Ryden I, Thurin E, Carstam L, Smits A, Gulati S, Henriksson R, Salvesen O, Store Jakola A. Psychotropic and anti-epileptic drug use, before and after surgery, among patients with low-grade glioma: a nationwide matched cohort study. BMC Cancer. 2021 Mar 8;21(1):248. doi: 10.1186/s12885-021-07939-w.
PubMed 33685410Thurin E, Forander P, Bartek J Jr, Gulati S, Ryden I, Smits A, Hesselager G, Salvesen O, Jakola AS. Depression and ability to work after vestibular schwannoma surgery: a nationwide registry-based matched cohort study on antidepressants, sedatives, and sick leave. Acta Neurochir (Wien). 2021 Aug;163(8):2225-2235. doi: 10.1007/s00701-021-04862-8. Epub 2021 May 7.
PubMed 33963435Wilson BR, Tringale KR, Hirshman BR, Zhou T, Umlauf A, Taylor WR, Ciacci JD, Carter BS, Chen CC. Depression After Spinal Surgery: A Comparative Analysis of the California Outcomes Database. Mayo Clin Proc. 2017 Jan;92(1):88-97. doi: 10.1016/j.mayocp.2016.06.030. Epub 2016 Nov 9.
PubMed 27836112Menard C, Hodes GE, Russo SJ. Pathogenesis of depression: Insights from human and rodent studies. Neuroscience. 2016 May 3;321:138-162. doi: 10.1016/j.neuroscience.2015.05.053. Epub 2015 May 30.
PubMed 26037806Wancata J, Windhaber J, Bach M, Meise U. Recognition of psychiatric disorders in nonpsychiatric hospital wards. J Psychosom Res. 2000 Feb;48(2):149-55. doi: 10.1016/s0022-3999(99)00098-7.
PubMed 10719131Eaton WW, Shao H, Nestadt G, Lee HB, Bienvenu OJ, Zandi P. Population-based study of first onset and chronicity in major depressive disorder. Arch Gen Psychiatry. 2008 May;65(5):513-20. doi: 10.1001/archpsyc.65.5.513.
PubMed 18458203Mueller TI, Leon AC, Keller MB, Solomon DA, Endicott J, Coryell W, Warshaw M, Maser JD. Recurrence after recovery from major depressive disorder during 15 years of observational follow-up. Am J Psychiatry. 1999 Jul;156(7):1000-6. doi: 10.1176/ajp.156.7.1000.
PubMed 10401442Ormel J, Petukhova M, Chatterji S, Aguilar-Gaxiola S, Alonso J, Angermeyer MC, Bromet EJ, Burger H, Demyttenaere K, de Girolamo G, Haro JM, Hwang I, Karam E, Kawakami N, Lepine JP, Medina-Mora ME, Posada-Villa J, Sampson N, Scott K, Ustun TB, Von Korff M, Williams DR, Zhang M, Kessler RC. Disability and treatment of specific mental and physical disorders across the world. Br J Psychiatry. 2008 May;192(5):368-75. doi: 10.1192/bjp.bp.107.039107.
PubMed 18450663
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Depression, an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06783842
- Acronym / sponsor ID
- 2024-01664-01 Periopdepr
- Keywords
- Perioperative medicine, Perioperative depression, Observational study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 700,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 20 Jan 2025 (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.
This observational cohort study studies two aspects of perioperative depression.
First, it examines the postoperative morbidity and mortality among patients with preoperative depression.
Secondly, in a subset of patients without signs of preoperative depression, the investigators describe the riskfactors for development of de-novo postoperative depression.
Detailed description
BACKGROUND With over 300 million surgeries performed yearly, the impact of perioperative morbidity weighs heavily on society[1]. Multiple studies have highlighted cardiac-[1], renal-[2], pulmonary-[3] and neurological complications[4] as well as other compound metrics of outcome.[5] Postoperative complications, if survived, sometimes result in major impact on function and quality of life.[6] Whilst somatic complications after major surgery are being increasingly investigated, the research field has scarce data on psychological outcomes such as postoperative depression. Most studies use specific surgical cohorts. These include studies of meningioma surgery[7] and glioma patients[8]; both with elevated risk of postoperative depression. In contrast, no significant difference in antidepressant use was found after vestibular schwannoma surgery.[9] When comparing spinal surgery to coronary artery bypass grafting, hysterectomy, cholecystectomy, chronic obstructive pulmonary disease, congestive heart failure exacerbation, and uncomplicated vaginal delivery, the former had the highest risk for postoperative depression.[10] Etiology of major depressive disorder (MDD) is poorly understood, and diagnosis is difficult.[11, 12] Many who experience a first episode of MDD will go on to suffer from recurrent episodes.[13, 14] When compared to equally disabling somatic disorders treatment for depression is less prevalent, indicating under-treatment of the condition.[15] Additionally, individuals with MDD are at elevated risk of cardiovascular disease and all cause-mortality.[16]
HYPOTHESIS The investigators hypothesize that surgery is a stressful event, potentially triggering depression. The investigators further hypothesize that in selected high-risk patients, postoperative new-onset depression is more common and potentially avoidable.
METHODS The investigators plan to use perioperative data from the surgical planning tool, Orbit. The Orbit cohort at Karolinska University Hospital in Solna and in Huddinge, two separate large university hospitals includes Swedish personal identity number (PIN), patient demographics, American Society of Anesthesiologists (ASA) physical status classification, type, date and duration of anesthesia and surgery. NOMESCO classification can be used to subgroup surgical procedures into sixteen categories; neuro, endocrine, ophthalmic, ear, nose and throat, oral and maxillofacial, cardiac, vascular, thoracic, breast, gastrointestinal, urologic, gynecologic, obstetric, orthopedic, dermatologic and minor surgery. The Orbit cohort is cross-matched with electronical medical records (EMR) allowing us to characterize the patients in the cohort based on pre- and postoperative ICD-codes (diagnoses, co-morbid conditions) and pre- and postoperative ATC-codes (medications). Hospital length of stay, readmissions and dates of death can also be retrieved from the EMR.
By merging Orbit data with EMR-data as described above it effectively allows us to investigate short- and long-term outcome for patients developing (new-onset) postoperative depression; this can be achieved by removing patients with depression diagnoses (using ICD-codes from the EMR) and/or patients with collected antidepressants (using ATC-codes from the EMR) in the years prior to surgery. What is the short- and long-term mortality for these patients? How do they far in terms of overall morbidity and health care utilization? The investigators can also characterize the short- and long-term outcome for patients with preoperative depression, focusing specifically on the patients excluded in the study two. How do these patients fare in term of risks for mortality, morbidity and health care utilization?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical cohort | – | –Adult patients undergoing surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This cohort is fully comprised of adult patients undergoing surgery at Karolinska University Hospital in Solna or in Huddinge
Key inclusion criteria (1 listed)
- Adult patients (18 years or older) undergoing surgery at Karolinska University Hospital in Solna or in Huddinge
Key exclusion criteria (1 listed)
- Patients under the age of 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality
Time frame: 30/60/90/365-day mortality
Death after index surgery, time frames (see below)
Days At Home Alive at 30 days after surgery
Time frame: 30 days
DAH-30 is calculated using mortality and hospitalisation data from the date of the index surgery (= Day 0). For example, if a patient died on day 2 after their surgery whilst still an inpatient, they would be assigned zero (0) days at home; if a patient was discharged from hospital on Day 6 after surgery but was subsequently re-admitted for 4 days before their second hospital discharge, then they would be assigned a DAH-30 value of 20. If a patient has complications and spends 16 days in hospital, and then is transferred to a nursing facility for rehabilitation, and spend 24 days there before finally being discharged to their own home, they would be assigned a DAH-30 value of zero (0), even though 30-16-24 = -10 because the minimum value of DAH-30 should be zero. If a patient dies within 30 days of surgery, irrespective of whether they have spent some time at home, DAH-30 will be scored as zero (0). That is, DAH-30 captures the impact of any complications after surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Results publication: PubMed 26313057Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes. Lancet. 2015 Apr 27;385 Suppl 2:S11. doi: 10.1016/S0140-6736(15)60806-6. Epub 2015 Apr 26.
- Results publication: PubMed 33976395Prowle JR, Forni LG, Bell M, Chew MS, Edwards M, Grams ME, Grocott MPW, Liu KD, McIlroy D, Murray PT, Ostermann M, Zarbock A, Bagshaw SM, Bartz R, Bell S, Bihorac A, Gan TJ, Hobson CE, Joannidis M, Koyner JL, Levett DZH, Mehta RL, Miller TE, Mythen MG, Nadim MK, Pearse RM, Rimmele T, Ronco C, Shaw AD, Kellum JA. Postoperative acute kidney injury in adult non-cardiac surgery: joint consensus report of the Acute Disease Quality Initiative and PeriOperative Quality Initiative. Nat Rev Nephrol. 2021 Sep;17(9):605-618. doi: 10.1038/s41581-021-00418-2. Epub 2021 May 11.
- Results publication: PubMed 27829093Fernandez-Bustamante A, Frendl G, Sprung J, Kor DJ, Subramaniam B, Martinez Ruiz R, Lee JW, Henderson WG, Moss A, Mehdiratta N, Colwell MM, Bartels K, Kolodzie K, Giquel J, Vidal Melo MF. Postoperative Pulmonary Complications, Early Mortality, and Hospital Stay Following Noncardiothoracic Surgery: A Multicenter Study by the Perioperative Research Network Investigators. JAMA Surg. 2017 Feb 1;152(2):157-166. doi: 10.1001/jamasurg.2016.4065.
- Results publication: PubMed 34303492Platzbecker K, Grabitz SD, Raub D, Rudolph MI, Friedrich S, Vinzant N, Kurth T, Weimar C, Bhatt DL, Nozari A, Houle TT, Xu X, Eikermann M. Development and external validation of a prognostic model for ischaemic stroke after surgery. Br J Anaesth. 2021 Nov;127(5):713-721. doi: 10.1016/j.bja.2021.05.035. Epub 2021 Jul 22.
- Results publication: PubMed 31317130Bell M, Eriksson LI, Svensson T, Hallqvist L, Granath F, Reilly J, Myles PS. Days at Home after Surgery: An Integrated and Efficient Outcome Measure for Clinical Trials and Quality Assurance. EClinicalMedicine. 2019 Apr 27;11:18-26. doi: 10.1016/j.eclinm.2019.04.011. eCollection 2019 May-Jun.
- Results publication: PubMed 20716567Grocott MP, Pearse RM. Prognostic studies of perioperative risk: robust methodology is needed. Br J Anaesth. 2010 Sep;105(3):243-5. doi: 10.1093/bja/aeq207. No abstract available.
- Results publication: PubMed 33773085Thurin E, Ryden I, Skoglund T, Smits A, Gulati S, Hesselager G, Bartek J Jr, Henriksson R, Salvesen O, Jakola AS. Impact of meningioma surgery on use of antiepileptic, antidepressant, and sedative drugs: A Swedish nationwide matched cohort study. Cancer Med. 2021 May;10(9):2967-2977. doi: 10.1002/cam4.3868. Epub 2021 Mar 26.
- Results publication: PubMed 33685410Ryden I, Thurin E, Carstam L, Smits A, Gulati S, Henriksson R, Salvesen O, Store Jakola A. Psychotropic and anti-epileptic drug use, before and after surgery, among patients with low-grade glioma: a nationwide matched cohort study. BMC Cancer. 2021 Mar 8;21(1):248. doi: 10.1186/s12885-021-07939-w.
- Results publication: PubMed 33963435Thurin E, Forander P, Bartek J Jr, Gulati S, Ryden I, Smits A, Hesselager G, Salvesen O, Jakola AS. Depression and ability to work after vestibular schwannoma surgery: a nationwide registry-based matched cohort study on antidepressants, sedatives, and sick leave. Acta Neurochir (Wien). 2021 Aug;163(8):2225-2235. doi: 10.1007/s00701-021-04862-8. Epub 2021 May 7.
- Results publication: PubMed 27836112Wilson BR, Tringale KR, Hirshman BR, Zhou T, Umlauf A, Taylor WR, Ciacci JD, Carter BS, Chen CC. Depression After Spinal Surgery: A Comparative Analysis of the California Outcomes Database. Mayo Clin Proc. 2017 Jan;92(1):88-97. doi: 10.1016/j.mayocp.2016.06.030. Epub 2016 Nov 9.
- Results publication: PubMed 26037806Menard C, Hodes GE, Russo SJ. Pathogenesis of depression: Insights from human and rodent studies. Neuroscience. 2016 May 3;321:138-162. doi: 10.1016/j.neuroscience.2015.05.053. Epub 2015 May 30.
- Results publication: PubMed 10719131Wancata J, Windhaber J, Bach M, Meise U. Recognition of psychiatric disorders in nonpsychiatric hospital wards. J Psychosom Res. 2000 Feb;48(2):149-55. doi: 10.1016/s0022-3999(99)00098-7.
- Individual participant dataSharing planned: Undecided. Individual participant data, may be shared to researchers that provide a methodological sound proposal
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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.
Max Bell, MD, Phd principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery With General Anesthesia and Depression - Major Depressive Disorder, run by Karolinska Institutet at 1 site in Sweden.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 22 Jan 2025. 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 Sweden. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Mortality (time frame: 30/60/90/365-day mortality). The study lists 2 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 NCT06783842, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.