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.

Condition studied

Depressive disorder

Investigational medicinal product(s)

Every trial of Amitriptyline and Citalopram across our registers →

Eligibility

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.