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Sertraline Hydrochloride

Clinical trials investigating Sertraline Hydrochloride are studying different patient groups, including people with hip or knee osteoarthritis and adults with major depressive disorder. These trials look at practical questions such as treatment feasibility, symptom change, and how patients respond over time.

Table of contents

Trial overview

These clinical trials investigate Sertraline Hydrochloride as part of broader studies of serotonin reuptake inhibitor treatment in different patient groups.[1][2] The source data shows two interventional trials: one in patients planned for hip or knee surgery and one in adults with major depressive disorder.[1][2]

Study in hip and knee arthroplasty

The first trial, 2023-509988-24-00, was a feasibility study about short-term temporary discontinuation of serotonin reuptake inhibitors in patients planned for hip or knee arthroplasty.[1] Arthroplasty means joint replacement surgery, and the study focused on hip and knee osteoarthritis patients who were using SSRI or SNRI therapy, including Sertraline Hydrochloride.[1]

This study was designed to see whether patients could stop their SSRI or SNRI treatment around the time of surgery, which is called the perioperative period.[1] The brief summary also says the researchers wanted to look at discontinuation syndrome and relapse of depression and anxiety, meaning possible symptoms after stopping treatment and return of mental health symptoms.[1]

Study in major depressive disorder

The second trial, NCT05973851, was a randomised controlled Phase 3 study in people with major depressive disorder who had a first-time treatment failure on their first-line treatment.[2] Randomised means participants were assigned by chance to different treatment groups, which helps make the comparison fairer.[2]

This trial compared a six-week early intensified pharmacological treatment with treatment as usual.[2] Sertraline Hydrochloride was one of many possible treatments listed in the intensified treatment group, alongside other medicines used for depression.[2]

Main outcomes and endpoints

In the surgery study, the main outcome was the proportion of patients planned for THA, TKA, or UKA who were able to discontinue SSRI or SNRI therapy during the perioperative period.[1] THA means total hip arthroplasty, TKA means total knee arthroplasty, and UKA means unicompartmental knee arthroplasty, which is a partial knee replacement.[1]

In the depression study, the primary outcome was the mean change in symptom severity from baseline to six weeks, measured with the MADRS total score.[2] Baseline means the starting point before treatment changes, and symptom severity means how strong the depression symptoms are.[2]

Who the trials were designed for

The surgery trial was designed for patients with hip and knee osteoarthritis who were planned for joint replacement surgery and were already receiving SSRI or SNRI treatment.[1] The source data does not list a specific age range or other detailed entry rules, so the clearest description is that it targeted selected arthroplasty patients taking these medicines.[1]

The depression trial was designed for subjects with major depressive disorder who had a first-time failure of their first-line treatment.[2] The study also planned subgroup analysis for participants with first-time treatment failure, showing special interest in this group.[2]

Trial status and enrollment

The surgery study was withdrawn and had an enrollment target of 100 participants.[1] Withdrawn means the study did not continue as planned.[1]

The depression study was authorised and had an enrollment of 453 participants.[2] This later-stage Phase 3 trial gives more weight to the comparison between intensified treatment and treatment as usual in a larger group of people.[2]

Trial ID Phase Condition studied Status Enrollment
2023-509988-24-00 Low Intervention Hip and knee osteoarthritis Withdrawn 100
NCT05973851 Phase 3 Major depressive disorder Authorised 453

FAQ

  • What are the clinical trials of Sertraline Hydrochloride studying? The trials are studying two main situations: temporary stopping of serotonin reuptake inhibitor treatment before hip or knee surgery, and intensified treatment for major depressive disorder. They look at whether patients can complete the study plan and how symptoms change.
  • Who may be included in these trials? One trial focused on patients planned for hip or knee arthroplasty who were using SSRI or SNRI treatment, including Sertraline Hydrochloride. Another trial focused on people with major depressive disorder who had a first-time treatment failure on their first-line treatment.
  • What phases are these trials in? One study is listed as Low Intervention, which means it has a simpler research design. The other study is Phase 3, which usually means a later-stage trial that compares treatment approaches in a larger group.
  • What outcomes are being measured? One trial measures the proportion of patients who can stop SSRI or SNRI treatment around surgery. The other trial measures change in depression symptoms using the MADRS total score after six weeks.
  • What is the status of these trials? One trial was withdrawn, so it did not continue as planned. The other trial was authorised, meaning it had permission to begin.

Ongoing Clinical Trials on Sertraline Hydrochloride

  • Study on the Effect of Ketamine and Esketamine in Patients with Major Depressive Disorder After First-Line Treatment Failure

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Germany Greece Italy Spain

  • Study on Temporarily Stopping Duloxetine, Sertraline, and Paroxetine in Patients with Hip or Knee Osteoarthritis Undergoing Surgery

    Not yet recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

Glossary

  • Clinical trial: A planned research study in people that tests a medical question, such as whether a treatment approach is workable or helps symptoms.
  • Interventional study: A study where researchers assign a treatment or treatment plan and then measure the results.
  • Withdrawn: A study status meaning the trial did not go forward, usually before participants were enrolled.
  • Authorised: A study status meaning the trial received permission to start.
  • Phase 3: A later stage of testing that usually includes more participants and compares treatment options more closely.
  • Low Intervention: A trial with a simpler research approach and limited extra procedures beyond usual care.
  • Arthroplasty: Surgery to replace or repair a joint, such as the hip or knee.
  • Osteoarthritis: A joint condition that causes pain and stiffness because the joint wears down over time.
  • Major depressive disorder: A serious mood condition with ongoing low mood and other symptoms that affect daily life.
  • MADRS: The Montgomery Åsberg Depression Rating Scale, a tool used to measure how severe depression symptoms are.
  • Treatment as usual: The standard care or normal treatment approach used outside the research study.
  • Perioperative: The time before, during, and after surgery.

References