Short-term Efficacy of Antidepressant in Patients Underwent TKA

Osteoarthritis Of Knee Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03110172
• Other study ID #: I84412001
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: April 3, 2017
• Last updated: April 12, 2017
• Start date: January 2017
• Est. completion date: July 2017

Study information

• Verified date: April 2017
• Source: Dalian Municipal Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 32
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 51 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Of Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Duloxetine Hydrochloride
The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation

Locations

Country	Name	City	State
China	Dalian municipal central hospital	Dalian	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Dalian Municipal Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	up to 6 months
Primary	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	up to 6 months
Secondary	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	up to 6 months
Secondary	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	up to 6 months