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serteralin in THA

The effect of Selective Serotonin Reuptake Inhibitors (sertraline) on the outcomes of total hip arthroplasty in depressed patients: A randomized double-blind clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200305046700N4
Enrollment
120
Registered
2024-09-11
Start date
2024-08-22
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

hip osteoarthritis. Osteoarthritis of hip

Interventions

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Age 18-70- Candidate for hip joint replacement by an orthopedic specialist Diagnosis of depression by a psychiatrist The patient has the ability to understand the explanations and registers his verbal and written wishes in the informed consent form. Hamilton criteria score between 10 and 30 (mild to moderate depression)

Exclusion criteria

Exclusion criteria: Other psychiatric diseases that require medication Coagulopathy Pre-existing SSRI use Have a cognitive problem such as dementia The patient has a bleeding disorder History of drug side effects with sertraline Major drug interaction between the patient's previous medications and sertraline

Design outcomes

Primary

MeasureTime frame
The Western Ontario and McMaster University Arthritis Index (WOMAC) is widely used in the assessment of hip and knee osteoarthritis. It includes 24 items that are divided into 3 subscales: pain (5 items) - stiffness (2 items) - physical function (17 items). Timepoint: 0, 3, 6 months. Method of measurement: questionnaire.;Quantitative/discrete dependent HDRS is Hamilton's depression rating scale based on a 17-item criteria, which scores 0-7 normal, 8-16 mild depression, 17-23 moderate depression, and above 24 severe depression. Interview with a trained person 0-30. Timepoint: 0, 1, 3, 6 months. Method of measurement: questionnaire.

Secondary

MeasureTime frame
SF-12 Quantitative/Continuous Quality of Life Questionnaire (SF12) consists of 12 questions and measures the quality of life in two general dimensions of physical health and mental health. Interview with a trained person 0-100. Timepoint: 0,1,3,6 months. Method of measurement: questionnaire.;KSS Quantitative/Continuous Knee Society Index (KSS) assesses pain for a total of 50 points, stability, 25 points, and range of motion, 25 points. A maximum score of 100 is obtained when there is no pain, with good knee alignment in extension, and at least 125 degrees of range of motion, without any anteroposterior or mediolateral instability. Interview with a trained person 0-100. Timepoint: 0,1,3,6 months. Method of measurement: questionannaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammadreza Razzaghof

Tehran University of Medical Sciences

m-razzaghof@razi.tums.ac.ir+98 21 6658 0196

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026