A multicenter randomized, controlled, single-blind, adaptive phase IV clinical trial to evaluate the efficiency and effectiveness of a pre-emptive pharmacogenetic strategy for antidepressant selection in patients with depressive disorder: The PREDICT adaptive clinical trial.

2025-522967-13-00 · tracked via the Priya Life Science EU tracker

Sponsor

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

Sponsor type

Patient organisation/association

Therapeutic area

Mental Disorders

Decision date

11/01/2026

Enrollment target

240

Sites

Spain

Condition studied

Depressive disorder

Investigational medicinal product(s)

mirtazapina cinfa 30 mg comprimidos recubiertos con película EFGBupropión Sandoz 150 mg comprimidos de liberación modificada EFG.Quetiapina NORMON 300 mg comprimidos recubiertos con película EFGAmitriptyline hydrochloride 25 mg film-coated tabletsVenlafaxina Retard Sandoz 75 mg cápsulas duras de liberación prolongada EFGLantanon 10 mg comprimidos recubiertos con películaAnafranil 10 mg comprimidos recubiertosFluoxetina Viatris 20 mg cápsulas duras EFGFluvoxamina Sandoz 50 mg comprimidos recubiertos con pelicula EFGNORFENAZIN “25”®Valdoxan 25 mg film-coated tabletsCitalopram Normon 20 mg comprimidos recubiertos con película EFGPAROXETINA 20 mg comprimidos recubiertos con película EFGSertralina cinfa 150 mg comprimidos recubiertos con películaDesvenlafaxina cinfa 50 mg comprimidos de liberación prolongada EFGDuloxetina Eignapharma 30 mg cápsulas duras gastrorresistentes EFGVortioxetina Kern Pharma 5 mg comprimidos recubiertos con película EFGescitalopram cinfa 10 mg comprimidos recubiertos con película EFGTOFRANIL 10 mg comprimidos recubiertosSurmontil 25 mg comprimidos recubiertos con película

Eligibility

Age group

18-64 years, 65+ years

Sex

Female, Male

Primary endpoint

Symptom remission, based on changes in depression severity scores (PHQ-9 and MADRS), after initiation of a new antidepressant treatment following failure of the prior therapy at study entry.

Endpoint detail

Total number of therapeutic adjustments performed within 16 weeks after initiation of a new antidepressant treatment following failure of the prior therapy at study entry. “Therapeutic adjustment” includes: • Change of antidepressant (switch) • Dose increase or decrease (beyond standard titration), Total number and type of Psychotherapeutic appointments—such as cognitive behavioral therapy (CBT) and interpersonal therapy (IPT) per arm. • Total number of hospitalizations per arm. • Total number of clinical visits (scheduled and unscheduled). • Total number of non-scheduled psychiatric consultations in each arm., Incremental cost-effectiveness ratios (ICERs), comparing cost differences relative to differences in clinical efficacy between the two arms., Total number of adverse events (AEs) in each cohort., Total number of hospitalizations per arm., Total number of clinical visits (scheduled and unscheduled)., Total number of non-scheduled psychiatric consultations in each arm., Total number of participants with symptom remission remains at the end of the 16-week follow-up period., Total costs in the intervention arm (including pharmacogenetic testing and clinical event costs) versus total costs related to clinical events in the control arm., Incremental cost of pharmacogenetic testing and associated implementation procedures., Total number of serious adverse events (SAEs) in each cohort., Total number of dropouts due to SAEs., Incidence of adverse events of special interest: Suicidal ideation, Suicide attempt, Serotonin syndrome, and Neuroleptic malignant syndrome.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

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