Table of contents
- Clinical trials overview
- Who may participate
- Conditions studied in the trials
- Study phases and designs
- Outcomes measured
- Trial highlights
- Patient-friendly terms
Clinical trials overview
These studies investigate Sertraline in several research settings, mostly for mental health conditions and one non-psychiatric cancer setting.[1][2] The trials compare Sertraline with other treatment strategies, placebo, or treatment as usual, depending on the study question.[1][3]
Some studies focus on whether Sertraline is part of a better treatment plan after a first treatment has failed, while others look at personalized medicine, tapering off antidepressants, or symptom control in specific patient groups.[3][4][5]
Who may participate
The target populations include adults with major depressive disorder, bipolar depression, remitted depressive disorders, and depressive symptoms linked to heart failure with preserved ejection fraction.[1][2][3][4]
Other studies include people with anxiety disorders, psychotic disorders, schizophrenia-related disorders, and patients with advanced gastroesophageal cancer receiving immunochemotherapy.[5][6] One study also includes adults with depression who need a new antidepressant after previous treatment failure.[7]
Conditions studied in the trials
Several trials focus on depression in different forms, including standard depression, bipolar depression, and depression that has already improved but may return when treatment is stopped.[2][3][7] One study looks at people with heart failure and mood symptoms, using a cardiovascular outcome as the main endpoint.[1]
A separate trial studies Sertraline in a cancer setting, where the goal is to see whether it may help improve response to first-line immunochemotherapy in metastatic gastroesophageal adenocarcinoma.[6] This is different from the mental health studies because the main focus is cancer response, not mood symptoms.[6]
Study phases and designs
Most of the Sertraline trials in the data are Phase 3 studies, which means they are testing the treatment in larger groups and comparing it with other strategies or usual care.[1][2][3][4][5][7]
There is also one Phase 2 study in advanced gastroesophageal cancer, which is a smaller and earlier study aimed at learning more about treatment response.[6] One completed study is Phase 4 and looks at adjunctive therapy in adults with major depressive disorder after an inadequate response to an initial antidepressant trial.[8]
The designs include interventional trials, meaning the researchers assign treatment strategies and then measure what happens.[1][2] Some studies compare intensified treatment with treatment as usual, while others compare different tapering methods or personalized dosing plans.[3][4][5][7]
Outcomes measured
The main outcomes include changes in depression symptom scores, such as the MADRS and PHQ-9, which help show whether symptoms improve after treatment starts.[2][3][7]
Other outcomes include the proportion of patients who can stop antidepressants without restarting them, patient recovery at 24 weeks, and time to hospitalization for cardiovascular reasons or death from any cause.[1][4][5]
The cancer trial uses a different outcome: the best tumor response after at least one cycle of immunochemotherapy, measured with RECIST 1.1 criteria.[6] This shows that the same medicine can be studied for very different goals depending on the disease area.[6]
Trial highlights
Heart failure study: This completed Phase 3 trial followed 485 people with heart failure with preserved ejection fraction and depressive-anxiety symptoms, and it measured time to cardiovascular hospitalization or death.[1]
Discontinuation study: This authorised Phase 3 study in 150 people with remitted depressive disorders looks at whether antidepressants can be stopped safely without restarting during 16 weeks after tapering.[2]
Bipolar depression study: This authorised Phase 3 trial in 458 participants compares intensified treatment with usual care after first-line treatment failure and uses change in MADRS score at six weeks as the main outcome.[3]
Depression study with dexamethasone add-on: This authorised Phase 3 trial includes 300 participants with depression and measures change in MADRS-10 score at day 7.[4]
Personalized psychiatry studies: These authorised Phase 3 trials test pharmacogenetics, which means using genetic information to help choose treatment, in large psychiatric groups that include mood, anxiety, and psychotic disorders.[5][7]
Cancer study: This authorised Phase 2 trial includes 35 patients with gastroesophageal cancer and looks at tumor response after immunochemotherapy.[6]
Patient-friendly terms
Treatment as usual means the standard care that participants would normally receive outside the trial.[3][4]
Tapering means slowly lowering a medicine dose over time instead of stopping all at once.[2]
Withdrawal symptoms are unwanted symptoms that can appear when a medicine is reduced or stopped.[2]
Biomarkers are measurable signs in the body, such as blood or tissue markers, that researchers use to study disease or treatment effects.[1]
Pharmacogenetics means studying whether genes can help predict which treatment may work best for a person.[5][7]
