Esketamine and Perioperative Depressive Symptoms

Sponsor
Beijing Tiantan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04425473
Collaborator
(none)
564
1
2
34.3
16.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
564 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Esketamine on Perioperative Depressive Symptoms in Patients Undergoing Major Surgery
Actual Study Start Date :
Feb 19, 2021
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Esketamine

Drug: Esketamine
Esketamine will be administrated intravenously when suturing incision, with total dose of 0.2mg/kg and continuous infusion for 40 minutes.

Placebo Comparator: Placebo

Drug: Normal saline
Equivalent amount of normal saline will be administrated intravenously suturing incision.

Outcome Measures

Primary Outcome Measures

  1. Depressive symptoms remission [Postoperative 3-day]

    Remission is defined as MADRS total score no more than 10

Secondary Outcome Measures

  1. MADRS scores [Postoperative 3-day]

    The differences in MADRS scores

  2. Depressive symptoms response [Postoperative 3-day]

    The rates of patients achieving a response

  3. Severe pain [postoperative 3-day]

    The rate of severe pain after surgery

  4. Side-effects and Adverse events [During surgery or up to 7 days after surgery]

    All drug-related adverse events during surgery or before discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Tiantan Hospital, Capital Medical University Beijing China 100070

Sponsors and Collaborators

  • Beijing Tiantan Hospital

Investigators

  • Study Chair: Ruquan Han, M.D., Ph D., Beijing Tiantan Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruquan Han, Professor, Beijing Tiantan Hospital
ClinicalTrials.gov Identifier:
NCT04425473
Other Study ID Numbers:
  • Z191100006619067
First Posted:
Jun 11, 2020
Last Update Posted:
Feb 23, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2022