Short-term Efficacy of Antidepressant in Patients Underwent TKA

NCT03110172 | Unknown Phase 1

• 1 other identifier: I84412001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Of Knee

Keywords

Osteoarthritis; Depression; Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Pain score of participants with Duloxetine as assessed by Western Ontario and McMaster Universities Index after 8 weeks of treatment.

  up to 6 months

• Function score of participants with Duloxetine as assessed by Knee Society Score after 8 weeks of treatment.

  up to 6 months

Study Arms (4)

KSS scale

ACTIVE COMPARATOR

Knee Society Score with Duloxetine Hydrochloride

Drug: Duloxetine Hydrochloride

HAMD-17 scale

ACTIVE COMPARATOR

Hamilton Depression Score with Duloxetine Hydrochloride

Drug: Duloxetine Hydrochloride

SF-36 scale

ACTIVE COMPARATOR

Medical Outcomes Study Short Form-36 score with Duloxetine Hydrochloride

Drug: Duloxetine Hydrochloride

WOMAC scale

ACTIVE COMPARATOR

Western Ontario and McMaster Universities Index with Duloxetine Hydrochloride

Drug: Duloxetine Hydrochloride

Interventions

Duloxetine Hydrochloride DRUG

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

Also known as: Cymbalta

HAMD-17 scale; KSS scale; SF-36 scale; WOMAC scale

Eligibility Criteria

• Age: 51 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dalian Municipal Central Hospital: lead

Study Sites (1)

Dalian municipal central hospital

Dalian, Liaoning, 116000, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Depression; Pain

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• QI Zhiming, MD

  Dalian Municipal Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator，Graduate Student

Model Details: 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.

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 12, 2017
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: April 14, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)