In short
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.
Key points
- Clinical trials investigating Sertraline Hydrochloride are looking at different patient groups and different research questions. One withdrawn study focused on people planned for hip or knee arthroplasty and asked whether short-term stopping of SSRI or SNRI treatment was possible. Another authorised Phase 3 study focused on major depressive disorder in adults who had a first-time treatment failure on first-line treatment. That study compared an early intensified treatment approach with treatment as usual. The main outcome in the depression study was change in symptom severity measured by the MADRS after six weeks. Together, these trials show interest in both practical treatment planning and symptom improvement.
Trial overview
These clinical trials investigate Sertraline Hydrochloride as part of broader studies of serotonin reuptake inhibitor treatment in different patient groups. The source data shows two interventional trials: one in patients planned for hip or knee surgery and one in adults with major depressive disorder.
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. 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.
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. 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.
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. Randomised means participants were assigned by chance to different treatment groups, which helps make the comparison fairer.
This trial compared a six-week early intensified pharmacological treatment with treatment as usual. Sertraline Hydrochloride was one of many possible treatments listed in the intensified treatment group, alongside other medicines used for depression.
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. THA means total hip arthroplasty, TKA means total knee arthroplasty, and UKA means unicompartmental knee arthroplasty, which is a partial knee replacement.
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. Baseline means the starting point before treatment changes, and symptom severity means how strong the depression symptoms are.
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. 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.
The depression trial was designed for subjects with major depressive disorder who had a first-time failure of their first-line treatment. The study also planned subgroup analysis for participants with first-time treatment failure, showing special interest in this group.
Trial status and enrollment
The surgery study was withdrawn and had an enrollment target of 100 participants. Withdrawn means the study did not continue as planned.
The depression study was authorised and had an enrollment of 453 participants. 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.