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TRIMIPRAMINE MALEATE

Clinical trials investigating TRIMIPRAMINE MALEATE are studying treatment strategies in people with depressive disorder. The main goal is to see whether a pre-emptive pharmacogenetic approach can improve antidepressant selection, symptom remission, and overall care compared with standard practice.

Table of contents

Trial overview

The available clinical trial is an interventional study called the PREDICT clinical trial, and it is authorised.[1] It studies depressive disorder and looks at whether a pre-emptive pharmacogenetic strategy can improve the choice of antidepressant treatment after a previous treatment has failed.[1]

The trial includes 240 participants and is in Phase 3.[1] Its brief summary says the study compares a personalized medicine approach with standard clinical practice in people who are starting a new therapy after treatment failure.[1]

Who the trial is for

This trial is for patients with depressive disorder who need a new antidepressant after their prior therapy did not work well enough.[1] The source data does not give more detailed entry rules such as age limits or exact lab requirements.[1]

  • Target population: people with depressive disorder.[1]

  • Treatment situation: starting a new antidepressant after prior treatment failure.[1]

  • Study setting: patients are being evaluated in a real treatment decision context, not just for one fixed drug choice.[1]

What is being studied

The main question is whether a pre-emptive pharmacogenetic strategy can help choose antidepressants better than usual care.[1] Pre-emptive means the testing is done before the treatment decision is made, and pharmacogenetic means the study uses gene-related information to guide medicine selection.[1]

The study also uses demographic, clinical, and concomitant medication data when making treatment decisions.[1] Concomitant medication means other medicines a patient is already taking at the same time.[1]

Although the trial is about treatment selection rather than one single drug, TRIMIPRAMINE MALEATE is included among the treatment options listed in the study data.[1]

Trial phase and design

This is a Phase 3 clinical trial.[1] Phase 3 trials usually test how well a strategy works in a larger group and help compare it with routine care.[1]

The study is interventional, which means researchers actively assign or guide the treatment approach being tested.[1] In this case, the intervention is the personalized selection strategy, not only a single medicine.[1]

Outcomes being measured

The main outcome is symptom remission, meaning the depression symptoms improve a lot or may no longer be present.[1] The trial measures this by looking at changes in depression severity scores after the new antidepressant treatment begins.[1]

  • PHQ-9: a patient questionnaire used to measure depression severity.[1]

  • MADRS: a clinician-rated scale used to measure how severe depression symptoms are.[1]

The outcome is assessed after initiation of the new antidepressant treatment following failure of the prior therapy at study entry.[1]

Treatments in the study

The intervention list includes many antidepressants and related medicines, such as escitalopram, duloxetine, fluvoxamine, sertraline, desvenlafaxine, fluoxetine, vortioxetine, venlafaxine, amitriptyline hydrochloride, citalopram, bupropion, mirtazapine, valproxan, quetiapine, and TRIMIPRAMINE MALEATE.[1]

These medicines are part of the treatment selection process being compared in the trial, so the study is focused on choosing the right antidepressant strategy rather than testing only one product by itself.[1]

  • Antidepressant choices: the trial includes several medicines so researchers can compare how well the selection strategy works in practice.[1]

  • Personalized selection: the study uses gene-related and clinical information to help decide which treatment may work best.[1]

Patient-focused summary

For patients, this trial is about finding a better way to choose antidepressant treatment after one treatment has not helped enough.[1] The study asks whether adding genetic testing and other patient information can improve the chance of remission compared with usual care.[1]

The source data does not report results yet, so the main focus is on the study goal, the patient group, and the outcomes being measured.[1]

Trial ID Phase Condition studied Status Enrollment
2025-522967-13-00 Phase 3 Depressive disorder Authorised 240

FAQ

  • What are the clinical trials about? The trial is testing a personalized medicine strategy for antidepressant selection in people with depressive disorder. It compares pre-emptive pharmacogenetic testing plus clinical information with standard care.
  • Who can take part in the trial? The target population is patients with depressive disorder who are starting a new antidepressant after a previous treatment has not worked. The study is designed for adults in this treatment situation.
  • What phase is the trial? This is a Phase 3 trial. Phase 3 studies usually look at how well a treatment strategy works in a larger group of people.
  • What is the main result the trial measures? The main outcome is symptom remission, which means the depression symptoms become much better or go away. The trial measures this using changes in PHQ-9 and MADRS scores after the new treatment starts.
  • What treatments are being compared? The study includes many antidepressant and related medicines as possible treatment choices, such as escitalopram, duloxetine, sertraline, fluoxetine, venlafaxine, and TRIMIPRAMINE MALEATE. The trial is not focused on one drug alone, but on how treatment is selected.

Ongoing Clinical Trials on TRIMIPRAMINE MALEATE

  • Testing a Pharmacogenetic-Guided Treatment Selection Strategy with Antidepressant Drug Combination for Patients with Depressive Disorder

    Not yet recruiting

    3 1 1 1
    Investigated drugs:
    Spain

Glossary

  • Depressive disorder: A medical condition with ongoing low mood, loss of interest, and other symptoms that affect daily life.
  • Pharmacogenetic testing: A test that looks at genes to see how they may affect a person's response to a medicine.
  • Biomarker: A measurable sign in the body, such as a gene-related marker, that may help guide treatment choices.
  • Personalized medicine: A treatment approach that uses a person's medical and biological information to choose the best care.
  • Standard clinical practice: Usual care that doctors provide without using the special trial strategy being tested.
  • Antidepressant: A medicine used to treat depressive disorder.
  • Remission: A state where symptoms are greatly reduced or no longer present.
  • PHQ-9: A questionnaire used to measure depression severity.
  • MADRS: A clinician-rated scale used to measure how severe depression symptoms are.
  • Phase 3: A later stage of clinical research that usually studies how well a strategy works in a larger group of people.

References

  1. https://clinicaltrials.gov/study/2025-522967-13-00