Depressive disorder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGVortioxetina Kern Pharma 5 mg comprimidos recubiertos con película EFG
DRUGescitalopram cinfa 10 mg comprimidos recubiertos con película EFG
DRUGSertralina cinfa 150 mg comprimidos recubiertos con película
DRUGQuetiapina NORMON 300 mg comprimidos recubiertos con película EFG
DRUGBupropión Sandoz 150 mg comprimidos de liberación modificada EFG.
DRUGAnafranil 10 mg comprimidos recubiertos
DRUGVenlafaxina Retard Sandoz 75 mg cápsulas duras de liberación prolongada EFG
DRUGTOFRANIL 10 mg comprimidos recubiertos
DRUGFluoxetina Viatris 20 mg cápsulas duras EFG
DRUGLantanon 10 mg comprimidos recubiertos con película
DRUGDuloxetina Eignapharma 30 mg cápsulas duras gastrorresistentes EFG
DRUGValdoxan 25 mg film-coated tablets
DRUGAmitriptyline hydrochloride 25 mg film-coated tablets
DRUGNORFENAZIN “25”®
DRUGFluvoxamina Sandoz 50 mg comprimidos recubiertos con pelicula EFG
DRUGmirtazapina cinfa 30 mg comprimidos recubiertos con película EFG
DRUGPAROXETINA 20 mg comprimidos recubiertos con película EFG
DRUGCitalopram Normon 20 mg comprimidos recubiertos con película EFG
DRUGSurmontil 25 mg comprimidos recubiertos con película
DRUGDesvenlafaxina cinfa 50 mg comprimidos de liberación prolongada EFG
Sponsors
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 num | — |
Countries
Spain
Outcome results
None listed