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Esketamine and Perioperative Depressive Symptoms

Primary Purpose

Depressive Symptoms, Esketamine, Perioperative Complication

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Esketamine
Normal saline
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tiantan Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Esketamine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Depressive symptoms remission
Remission is defined as MADRS total score no more than 10

Secondary Outcome Measures

MADRS scores
The differences in MADRS scores
Depressive symptoms response
The rates of patients achieving a response
Severe pain
The rate of severe pain after surgery
Side-effects and Adverse events
All drug-related adverse events during surgery or before discharge

Full Information

First Posted
June 8, 2020
Last Updated
March 21, 2023
Sponsor
Beijing Tiantan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04425473
Brief Title
Esketamine and Perioperative Depressive Symptoms
Official Title
Effect of Esketamine on Perioperative Depressive Symptoms in Patients Undergoing Major Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 19, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Esketamine, Perioperative Complication, Major Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
564 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Esketamine
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Esketamine
Intervention Description
Esketamine will be administrated intravenously when suturing incision, with total dose of 0.2mg/kg and continuous infusion for 40 minutes.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Equivalent amount of normal saline will be administrated intravenously suturing incision.
Primary Outcome Measure Information:
Title
Depressive symptoms remission
Description
Remission is defined as MADRS total score no more than 10
Time Frame
Postoperative 3-day
Secondary Outcome Measure Information:
Title
MADRS scores
Description
The differences in MADRS scores
Time Frame
Postoperative 3-day
Title
Depressive symptoms response
Description
The rates of patients achieving a response
Time Frame
Postoperative 3-day
Title
Severe pain
Description
The rate of severe pain after surgery
Time Frame
postoperative 3-day
Title
Side-effects and Adverse events
Description
All drug-related adverse events during surgery or before discharge
Time Frame
During surgery or up to 7 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruquan Han, M.D., Ph D.
Phone
8610-59976660
Email
ruquan.han@ccmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ruquan Han, M.D., Ph D.
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruquan Han, M.D., Ph.D
Phone
8610-59976660
Email
ruquan.han@ccmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The datasets will be available from the primary investigator (Ruquan Han, Email: ruquan.han@ccmu.edu.cn) upon reasonable request after the publication of the study results.
IPD Sharing Time Frame
After the publication of the study results.
IPD Sharing Access Criteria
Publication in peer reviewed journal
Citations:
PubMed Identifier
35473735
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.
Results Reference
derived

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Esketamine and Perioperative Depressive Symptoms

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