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Short-term Efficacy of Antidepressant in Patients Underwent TKA

Primary Purpose

Osteoarthritis Of Knee

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Duloxetine Hydrochloride
Sponsored by
Dalian Municipal Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis Of Knee focused on measuring Osteoarthritis, Depression, Pain

Eligibility Criteria

51 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. No extra articular malformations are diagnosed and accord with Kellgren-Lawrence criteria
  2. Primary TKA surgery,Varus is smaller than 20°
  3. Always there is no history of mental illness, no history of relevant medicine
  4. Be able to read and understand Chinese, with good communication skills
  5. Voluntary participation in this clinical study

Exclusion Criteria:

  1. Previous history of mental and psychological illness
  2. With severe diseases in respiratory system, circulatory system or digestive system
  3. Allergic to duloxetine and celecoxib

Sites / Locations

  • Dalian municipal central hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

KSS scale

HAMD-17 scale

SF-36 scale

WOMAC scale

Arm Description

Knee Society Score with Duloxetine Hydrochloride

Hamilton Depression Score with Duloxetine Hydrochloride

Medical Outcomes Study Short Form-36 score with Duloxetine Hydrochloride

Western Ontario and McMaster Universities Index with Duloxetine Hydrochloride

Outcomes

Primary Outcome Measures

Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 4 weeks of treatment.
A face-to-face questionnaire will be conducted by two trained interviewers
Function score of participants with Duloxetine as assessed by Knee Society Score after 4 weeks of treatment.
A face-to-face questionnaire will be conducted by two trained interviewers

Secondary Outcome Measures

Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 8 weeks of treatment.
A face-to-face questionnaire will be conducted by two trained interviewers
Function score of participants with Duloxetine as assessed by Knee Society Score after 8 weeks of treatment.
A face-to-face questionnaire will be conducted by two trained interviewers

Full Information

First Posted
April 3, 2017
Last Updated
April 12, 2017
Sponsor
Dalian Municipal Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03110172
Brief Title
Short-term Efficacy of Antidepressant in Patients Underwent TKA
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (Actual)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dalian Municipal Central Hospital

4. Oversight

5. Study Description

Brief Summary
By taking certain antidepressant in early postoperative period，which is supposed to improve the psychological status of patients with osteoarthritis, explore the effect of certain antidepressant on the recovery of the early stage after the operation of knee joint replacement.
Detailed Description
In this study, the investigators are going to investigate the efficacy of Duloxetine on pain, physical function, mental health and quality of life in patients underwent TKAs. The control group is going to be given celecoxib 200mg/24h to 2 weeks after operation.On the basis of the above scheme, the treatment group is going to receiving duloxetine 60mg/24h to 8 weeks after operation.HAMD-17 scale, KSS scale, SF-36 scale and WOMAC scale will be used to evaluate the two groups before and after operation for 4 and 8 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Of Knee
Keywords
Osteoarthritis, Depression, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
All patients will be randomly divided into two groups. The control group is going to be given celecoxib 200mg/24h to 2 weeks after operation. On the basis of the above scheme, the The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KSS scale
Arm Type
Active Comparator
Arm Description
Knee Society Score with Duloxetine Hydrochloride
Arm Title
HAMD-17 scale
Arm Type
Active Comparator
Arm Description
Hamilton Depression Score with Duloxetine Hydrochloride
Arm Title
SF-36 scale
Arm Type
Active Comparator
Arm Description
Medical Outcomes Study Short Form-36 score with Duloxetine Hydrochloride
Arm Title
WOMAC scale
Arm Type
Active Comparator
Arm Description
Western Ontario and McMaster Universities Index with Duloxetine Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Duloxetine Hydrochloride
Other Intervention Name(s)
Cymbalta
Intervention Description
The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation
Primary Outcome Measure Information:
Title
Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 4 weeks of treatment.
Description
A face-to-face questionnaire will be conducted by two trained interviewers
Time Frame
up to 6 months
Title
Function score of participants with Duloxetine as assessed by Knee Society Score after 4 weeks of treatment.
Description
A face-to-face questionnaire will be conducted by two trained interviewers
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 8 weeks of treatment.
Description
A face-to-face questionnaire will be conducted by two trained interviewers
Time Frame
up to 6 months
Title
Function score of participants with Duloxetine as assessed by Knee Society Score after 8 weeks of treatment.
Description
A face-to-face questionnaire will be conducted by two trained interviewers
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
51 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: No extra articular malformations are diagnosed and accord with Kellgren-Lawrence criteria Primary TKA surgery,Varus is smaller than 20° Always there is no history of mental illness, no history of relevant medicine Be able to read and understand Chinese, with good communication skills Voluntary participation in this clinical study Exclusion Criteria: Previous history of mental and psychological illness With severe diseases in respiratory system, circulatory system or digestive system Allergic to duloxetine and celecoxib
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
QI Zhiming, MD
Organizational Affiliation
Dalian Municipal Central Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Dalian municipal central hospital
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Short-term Efficacy of Antidepressant in Patients Underwent TKA

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