Short-term Efficacy of Antidepressant in Patients Underwent TKA

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis Of Knee
• Intervention / Treatment: Drug: Duloxetine Hydrochloride

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.

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Dalian, Liaoning, China, 116000
      • Dalian Municipal Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: KSS scale; Knee Society Score with Duloxetine Hydrochloride	Drug: Duloxetine Hydrochloride; The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation; Other Names: Cymbalta
ACTIVE_COMPARATOR: HAMD-17 scale; Hamilton Depression Score with Duloxetine Hydrochloride	Drug: Duloxetine Hydrochloride; The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation; Other Names: Cymbalta
ACTIVE_COMPARATOR: SF-36 scale; Medical Outcomes Study Short Form-36 score with Duloxetine Hydrochloride	Drug: Duloxetine Hydrochloride; The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation; Other Names: Cymbalta
ACTIVE_COMPARATOR: WOMAC scale; Western Ontario and McMaster Universities Index with Duloxetine Hydrochloride	Drug: Duloxetine Hydrochloride; The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation; Other Names: Cymbalta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Dalian Municipal Central Hospital
• Investigators: Study Director: QI Zhiming, MD, Dalian Municipal Central Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ANTICIPATED): June 1, 2017
• Study Completion (ANTICIPATED): July 1, 2017

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (ACTUAL): April 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 14, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Depression; Osteoarthritis; Pain
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: I84412001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES