Skip to content

Short-term Efficacy of Antidepressant in Patients Underwent TKA

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03110172
Enrollment
32
Registered
2017-04-12
Start date
2017-01-31
Completion date
2017-07-31
Last updated
2017-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis Of Knee

Keywords

Osteoarthritis, Depression, Pain

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.

Interventions

DRUGDuloxetine Hydrochloride

The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation

Sponsors

Dalian Municipal Central Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
51 Years to 85 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 4 weeks of treatment.up to 6 monthsA 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.up to 6 monthsA face-to-face questionnaire will be conducted by two trained interviewers

Secondary

MeasureTime frameDescription
Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 8 weeks of treatment.up to 6 monthsA 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.up to 6 monthsA face-to-face questionnaire will be conducted by two trained interviewers

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026