Short-term Efficacy of Antidepressant in Patients Underwent TKA

NCT ID: NCT03110172

Last Updated: 2017-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Osteoarthritis Of Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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KSS scale

Knee Society Score with Duloxetine Hydrochloride

Group Type ACTIVE_COMPARATOR

Duloxetine Hydrochloride

Intervention Type DRUG

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

HAMD-17 scale

Hamilton Depression Score with Duloxetine Hydrochloride

Group Type ACTIVE_COMPARATOR

Duloxetine Hydrochloride

Intervention Type DRUG

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

SF-36 scale

Medical Outcomes Study Short Form-36 score with Duloxetine Hydrochloride

Group Type ACTIVE_COMPARATOR

Duloxetine Hydrochloride

Intervention Type DRUG

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

WOMAC scale

Western Ontario and McMaster Universities Index with Duloxetine Hydrochloride

Group Type ACTIVE_COMPARATOR

Duloxetine Hydrochloride

Intervention Type DRUG

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

Interventions

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Duloxetine Hydrochloride

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

Intervention Type DRUG

Other Intervention Names

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Cymbalta

Eligibility Criteria

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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
Minimum Eligible Age

51 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dalian Municipal Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhu Bin

Principal Investigator,Graduate Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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QI Zhiming, MD

Role: STUDY_DIRECTOR

Dalian Municipal Central Hospital

Locations

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Dalian municipal central hospital

Dalian, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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I84412001

Identifier Type: -

Identifier Source: org_study_id

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