Clinical trial NCT04425473: Esketamine and Perioperative Depressive Symptoms
Official title: Effect of Esketamine on Perioperative Depressive Symptoms in Patients Undergoing Major Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Depressive Symptoms
Esketamine
Perioperative Complication
Major Surgery
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 564
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Perioperative depressive symptoms (PDS) are common in population undergoing surgery, and this would be sharpened especially for complicated, high-risk major surgery. However, None of treatments could resolve this clinical problem during limited perioperative period. The remarkable effects of ketamine on treatment resistant depression have been verified by several clinical trials and the enantiomer S-ketamine (esketamine) showed similar antidepressant efficacy with better safety in recent studies. The efficacy and safety of esketamine administrated intra-operatively for PDS will be verified in this study. Other secondary outcomes such as anxiety, postoperative pain and psychiatric symptoms will also be investigated.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing elective major surgery
* Ages between 18 and 65 years old
* Moderate to severe depressive symptoms ( the Patient Health Questionnaire-9 scores equal to or more than 10 and Montgomery-Åsberg Depression Rating Scale scores equal to or more than 22 )
* Signed informed consent

Exclusion Criteria:

* Patients combined with aphasia or other conditions leads that patients inability to cooperate with the metal assessments;
* Tumor related injury of the 9th, 10th, 11th, 12th cranial nerve or patients need keeping intubation after surgery;
* Medical history of psychotic or bipolar disorder;
* Laboratory evidence of hormone levels disorder due to primary diseases;
* Body Mass Index more than 30 kg/㎡;
* Child-Pugh grade B or C;
* Major depressive disorder with antidepressant therapy in the past 2 weeks before screening;
* History of adverse events to ketamine or esketamine;
* Patients with repeated suicide attempts (QIDS-SR 12-item more than or equal to 3);
* History of drug abused;
* Pregnant or breastfeeding woman.

Primary outcomes:
measure: Depressive symptoms remission
timeFrame: Postoperative 3-day
Secondary outcomes:
measure: MADRS scores
timeFrame: Postoperative 3-day
measure: Depressive symptoms response
timeFrame: Postoperative 3-day
measure: Severe pain
timeFrame: postoperative 3-day
measure: Side-effects and Adverse events
timeFrame: During surgery or up to 7 days after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
Study officials:
affiliation: Beijing Tiantan Hospital
name: Ruquan Han, M.D., Ph D.
role: STUDY_CHAIR
References:
citation: Zhou Y, Ma B, Sun W, Wang J, Fu Y, Wang A, Wang G, Han R. Effect of esketamine on perioperative depressive symptoms in major surgery patients (PASSION II): study protocol for a randomised controlled trial. BMJ Open. 2022 Apr 26;12(4):e056713. doi: 10.1136/bmjopen-2021-056713.