Clinical trial • Phase IV • Psychiatry

FLUVOXAMINE MALEATE for Depressive disorder

Phase IV trial of FLUVOXAMINE MALEATE for Depressive disorder.

Overview

Trial Therapeutic Area: Psychiatry
Trial Disease: Depressive disorder
Trial Stage: Phase IV
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 22-09-2025
First CTIS Authorization Date: 11-01-2026

Trial design

Randomised, control arm: antidepressant treatment selected empirically by the treating physician following standard clinical practice and product labeling (no pharmacogenetic information provided). intervention arm: antidepressant treatment guided by a personalized medicine strategy integrating pre-emptive pharmacogenetic testing with individual clinical, demographic, and concomitant medication data presented via a web-based clinical decision-support tool and reviewed by an experienced clinical pharmacologist; treating physicians have access to these recommendations., adaptive Phase IV trial in Spain.

Randomised: Yes
Comparator: Control arm: antidepressant treatment selected empirically by the treating physician following standard clinical practice and product labeling (no pharmacogenetic information provided). Intervention arm: antidepressant treatment guided by a personalized medicine strategy integrating pre-emptive pharmacogenetic testing with individual clinical, demographic, and concomitant medication data presented via a web-based clinical decision-support tool and reviewed by an experienced clinical pharmacologist; treating physicians have access to these recommendations.
Adaptive: True, adaptive elements: potential adjustments based on interim analyses; randomization conducted via IWRS with potential adjustments following interim analyses as described in protocol. No detailed dose-escalation or stopping rules are specified in the available summary.
Target Sample Size: 240
Trial Duration For Participant: 112

Eligibility

Recruits 240 No vulnerable populations selected. Participants must be able to understand the study's purpose and risks and provide informed consent; voluntary signing of the informed consent form (ICF) is required. Participants are adults (>= 18 years). No assent or proxy consent procedures are described..

Pregnancy Exclusion: Pregnant or breastfeeding women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
Vulnerable Population: No vulnerable populations selected. Participants must be able to understand the study's purpose and risks and provide informed consent; voluntary signing of the informed consent form (ICF) is required. Participants are adults (>= 18 years). No assent or proxy consent procedures are described.

Inclusion criteria

{"criterion_text":"- Ability to understand the study's purpose and risks, provide informed consent, and authorize the use of confidential health information according to national and local privacy regulations.\n- Voluntary signing of the informed consent form (ICF).\n- Age += 18 years at the time of signing the ICF.\n- Ability and willingness to participate and follow the study for the majority of its duration.\n- Current first depressive episode, confirmed by a clinical diagnosis of depressive disorder according to standardized diagnostic criteria (e.g., ICD-11 or DSM-5), as documented in the medical record.\n- Currently receiving pharmacological treatment for depressive disorder at the time of study inclusion, with no more than one prior antidepressant treatment line, as determined by the treating physician.\n- Patient Health Questionnaire-9 (PHQ-9) Score: 10, and Montgomery-Asberg Depression Rating Scale (MADRS) Score: 18, both assessed within the two weeks preceding study inclusion.\n- No prior genotyping for CYP3A4, SLC6A4, HTR2A, CYP2D6, CYP2B6, or CYP2C19 genes.\n- Women of childbearing potential must agree to use highly effective contraception or practice sexual abstinence throughout the study and commit to avoiding pregnancy."}

Exclusion criteria

{"criterion_text":"- Reports suicidal thoughts nearly every day, based on PHQ-9 item 9.\n- Participants are unwilling or unable to comply with all scheduled visits, the treatment plan, laboratory tests, lifestyle considerations, or other study procedures.\n- Any condition or situation that precludes or interferes with compliance with the protocol.\n- The participant is currently enrolled in or has enrolled in a clinical trial within the three months preceding inclusion in the current study.\n- History of failure to respond or intolerance to more than one prior antidepressant treatment line for the current depressive episode.\n- History of manic, mixed, or hypomanic episodes, which are indicative of a bipolar disorder diagnosis and thus incompatible with inclusion in a depressive disorder trial.\n- A history of active psychotic episodes is indicative of a potential diagnosis of schizophrenia and is therefore considered incompatible with inclusion in a clinical trial for depressive disorders.\n- Depressive-like symptoms attributable to non-depressive conditions, such as Acute Stress Reaction, Uncomplicated Bereavement, or Premenstrual Dysphoric Disorder, which are excluded from the ICD-11 classification of depressive disorders.\n- Patients with a documented history of antidepressant treatment prescribed for Adjustment Disorder, Generalized Anxiety Disorder (GAD), or Post-Traumatic Stress Disorder (PTSD).\n- Currently hospitalized for psychiatric or medical reasons.\n- Have a known active drug substance abuse.\n- Pregnant or breastfeeding women, where pregnancy is defined as the state of a female after conception and until the termination of gestation."}

Endpoints

Primary endpoints

{"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured using changes in PHQ-9 and MADRS scores after initiation of a new antidepressant following prior treatment failure; remission assessed by changes in these depression severity scores."}

Secondary endpoints

{"endpoint_text":"- 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: •\tChange of antidepressant (switch) •\tDose increase or decrease (beyond standard titration)","definition_or_measurement_approach":"Count of therapeutic adjustments per participant within 16 weeks post-initiation; therapeutic adjustment defined as change of antidepressant or dose increase/decrease beyond standard titration."}
{"endpoint_text":"- Total number and type of Psychotherapeutic appointments—such as cognitive behavioral therapy (CBT) and interpersonal therapy (IPT) per arm. •\tTotal number of hospitalizations per arm. •\tTotal number of clinical visits (scheduled and unscheduled). •\tTotal number of non-scheduled psychiatric consultations in each arm.","definition_or_measurement_approach":"Counts per study arm of psychotherapeutic appointment types (e.g., CBT, IPT), hospitalizations, scheduled and unscheduled clinical visits, and non-scheduled psychiatric consultations."}
{"endpoint_text":"- Incremental cost-effectiveness ratios (ICERs), comparing cost differences relative to differences in clinical efficacy between the two arms.","definition_or_measurement_approach":"Calculation of ICERs comparing cost differences (including testing and implementation costs) relative to differences in clinical efficacy between intervention and control arms."}
{"endpoint_text":"- Total number of adverse events (AEs) in each cohort.","definition_or_measurement_approach":"Counting and tabulation of all adverse events by cohort."}
{"endpoint_text":"- Total number of hospitalizations per arm.","definition_or_measurement_approach":"Count of hospitalizations observed in each study arm."}
{"endpoint_text":"- Total number of clinical visits (scheduled and unscheduled).","definition_or_measurement_approach":"Count of all clinical visits (scheduled and unscheduled) per arm."}
{"endpoint_text":"- Total number of non-scheduled psychiatric consultations in each arm.","definition_or_measurement_approach":"Count of non-scheduled psychiatric consultations per arm."}
{"endpoint_text":"- Total number of participants with symptom remission remains at the end of the 16-week follow-up period.","definition_or_measurement_approach":"Count of participants who maintain symptom remission at the end of the 16-week follow-up, as defined by PHQ-9 and MADRS score criteria."}
{"endpoint_text":"- Total costs in the intervention arm (including pharmacogenetic testing and clinical event costs) versus total costs related to clinical events in the control arm.","definition_or_measurement_approach":"Sum and comparison of total costs in the intervention arm (including pharmacogenetic testing and implementation costs) versus costs related to clinical events in the control arm."}
{"endpoint_text":"- Incremental cost of pharmacogenetic testing and associated implementation procedures.","definition_or_measurement_approach":"Calculation of incremental costs attributable to pharmacogenetic testing and associated implementation procedures."}
{"endpoint_text":"- Total number of serious adverse events (SAEs) in each cohort.","definition_or_measurement_approach":"Count and classification of serious adverse events by cohort."}
{"endpoint_text":"- Total number of dropouts due to SAEs.","definition_or_measurement_approach":"Count of participant withdrawals attributable to serious adverse events."}
{"endpoint_text":"- Incidence of adverse events of special interest: Suicidal ideation, Suicide attempt, Serotonin syndrome, and Neuroleptic malignant syndrome.","definition_or_measurement_approach":"Incidence rates for specified events of special interest (suicidal ideation, suicide attempt, serotonin syndrome, neuroleptic malignant syndrome) in each arm."}

Recruitment

Planned Sample Size: 240
Recruitment Window Months: 35
Consent Approach: Participants must voluntarily sign an informed consent form (ICF) and be able to understand the study purpose and risks. Consent is provided by the participant (adults >=18). A subject information and informed consent form document is present in the trial documents. No assent or proxy consent procedures or specific languages for the ICF are specified in the available data.

Geography

Total Number Of Sites: 5
Total Number Of Participants: 240

Spain

Earliest CTIS Part Ii Submission Date: 21-10-2025
Latest Decision Or Authorization Date: 16-04-2026
Processing Time Days: 177
Number Of Sites: 5
Number Of Participants: 240

Sites

Site Name: Hospital Universitario Puerta De Hierro De Majadahonda
Department Name: Clinical Pharmacology
Contact Person Name: Gustavo Adolfo Centeno Soto
Contact Person Email: gustavoadolfo.centeno@salud.madrid.org

Site Name: Hospital Dr. R Lafora
Department Name: Psiquiatría
Contact Person Name: Ignacio Garcia Cabezas
Contact Person Email: igcabeza@salud.madrid.org

Site Name: Centro de Salud Mental Fuencarral
Department Name: Psiquiatría
Contact Person Name: Javier Curto
Contact Person Email: javier.curto@salud.madrid.org

Site Name: Hospital Universitario La Paz
Department Name: Psiquiatría
Contact Person Name: Rosa Villanueva
Contact Person Email: rosa.villanueva@salud.madrid.org

Site Name: Centro de Salud Mental Tetuán
Department Name: Psiquiatría
Contact Person Name: Jose Juan Rodríguez
Contact Person Email: josejuan.rodriguez@salud.madrid.org

Sponsor

Primary sponsor

Full Name: Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Organisation Type: Patient organisation/association
Country Of Registered Address: Spain

Investigational products

Investigational Product Name: Fluvoxamina Sandoz 50 mg comprimidos recubiertos con pelicula EFG
Active Substance: FLUVOXAMINE MALEATE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 63.276
Maximum Dose: 300 mg

Investigational Product Name: Quetiapina NORMON 300 mg comprimidos recubiertos con película EFG
Active Substance: QUETIAPINE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 71557
Maximum Dose: 600 mg

Investigational Product Name: Vortioxetina Kern Pharma 5 mg comprimidos recubiertos con película EFG
Active Substance: VORTIOXETINE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 89.389
Maximum Dose: 20 mg

Investigational Product Name: Lantanon 10 mg comprimidos recubiertos con película
Active Substance: MIANSERIN HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 54.407
Maximum Dose: 90 mg

Investigational Product Name: Valdoxan 25 mg film-coated tablets
Active Substance: AGOMELATINE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: EU/1/08/499/002
Maximum Dose: 50 mg

Investigational Product Name: Duloxetina Eignapharma 30 mg cápsulas duras gastrorresistentes EFG
Active Substance: DULOXETINE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 85900
Maximum Dose: 120 mg

Investigational Product Name: PAROXETINA 20 mg comprimidos recubiertos con película EFG
Active Substance: PAROXETINE
Modality: Small molecule
Routes Of Administration: OCULAR USE
Route: OCULAR USE
Authorisation Status: Marketing authorisation number: 64365
Maximum Dose: 50 mg

Investigational Product Name: Surmontil 25 mg comprimidos recubiertos con película
Active Substance: TRIMIPRAMINE MALEATE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 40115
Maximum Dose: 400 mg

Investigational Product Name: Bupropión Sandoz 150 mg comprimidos de liberación modificada EFG.
Active Substance: BUPROPION HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: ORAL
Route: ORAL
Authorisation Status: Marketing authorisation number: 79848
Maximum Dose: 300 mg

Investigational Product Name: Sertralina cinfa 150 mg comprimidos recubiertos con película
Active Substance: SERTRALINE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 84732
Maximum Dose: 200 mg

Investigational Product Name: NORFENAZIN “25”®
Active Substance: NORTRIPTYLINE HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 48463
Maximum Dose: 150 mg

Investigational Product Name: Citalopram Normon 20 mg comprimidos recubiertos con película EFG
Active Substance: CITALOPRAM HYDROBROMIDE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 66795
Maximum Dose: 40 mg

Investigational Product Name: Anafranil 10 mg comprimidos recubiertos
Active Substance: CLOMIPRAMINE HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 49.656
Maximum Dose: 250 mg

Investigational Product Name: mirtazapina cinfa 30 mg comprimidos recubiertos con película EFG
Active Substance: MIRTAZAPINE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 67.068
Maximum Dose: 45 mg

Investigational Product Name: TOFRANIL 10 mg comprimidos recubiertos
Active Substance: IMIPRAMINE HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 40.366
Maximum Dose: 200 mg

Investigational Product Name: Venlafaxina Retard Sandoz 75 mg cápsulas duras de liberación prolongada EFG
Active Substance: VENLAFAXINE HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 84220
Maximum Dose: 375 mg

Investigational Product Name: Amitriptyline hydrochloride 25 mg film-coated tablets
Active Substance: AMITRIPTYLINE HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: PL 49445/0218
Maximum Dose: 150 mg

Investigational Product Name: Desvenlafaxina cinfa 50 mg comprimidos de liberación prolongada EFG
Active Substance: DESVENLAFAXINE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 86783
Maximum Dose: 200 mg

Investigational Product Name: escitalopram cinfa 10 mg comprimidos recubiertos con película EFG
Active Substance: ESCITALOPRAM
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 71.430
Maximum Dose: 20 mg

Investigational Product Name: Fluoxetina Viatris 20 mg cápsulas duras EFG
Active Substance: FLUOXETINE
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: ORAL USE
Authorisation Status: Marketing authorisation number: 62661
Maximum Dose: 60 mg

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