Clinical trial to evaluate the effectiveness and efficiency of a pre-emptive pharmacogenetic strategy for antidepressant selection in patients with depressive disorder: The PREDICT clinical trial.

2025-522967-13-00 Protocol PREDICT Therapeutic use (Phase IV) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 5 sites · Protocol PREDICT

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Authorised, recruitment pending
Participants planned 240
Countries 1
Sites 5

Depressive disorder

Evaluate the effectiveness of a personalized medicine strategy that incorporates pre-emptive pharmacogenetic testing of biomarkers associated with antidepressant response, along with demographic, clinical, and concomitant medication data, compared to standard clinical practice in patients with depressive disorder who a…

Key facts

Sponsor
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Psychiatry and Psychology [F] - Mental Disorders [F03]
Decision date (initial)
2026-01-11
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

Evaluate the effectiveness of a personalized medicine strategy that incorporates pre-emptive pharmacogenetic testing of biomarkers associated with antidepressant response, along with demographic, clinical, and concomitant medication data, compared to standard clinical practice in patients with depressive disorder who are initiating a new therapy following prior treatment failure.

Secondary objectives 8

  1. To evaluate the efficiency of a personalized medicine strategy that integrates pre-emptive pharmacogenetic testing with clinical, demographic, and concomitant medication data into a web-based clinical decision-support tool, supported by expert pharmacological review, compared to standard clinical practice in patients with depressive disorder who are initiating a new antidepressant treatment following prior treatment failure.
  2. To evaluate healthcare resource utilization in both study arms.
  3. To assess clinical improvement or response.
  4. To evaluate time to remission.
  5. To assess the cost-effectiveness of a personalized medicine strategy compared to standard clinical practice.
  6. To calculate the incremental cost of implementing the personalized medicine strategy in routine clinical practice within the National Health System.
  7. To assess the incidence of adverse drug reactions and treatment discontinuation in both study arms.
  8. To evaluate time to remission

Conditions and MedDRA coding

Depressive disorder

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 A multicenter randomized, controlled, single-blind, adaptive phase IV clinical trial to evaluate eff
A multicenter, randomized, controlled, single-blind, adaptive phase IV clinical trial with a low-intervention design. The study is embedded within the iPHARMGx project framework. It aims to evaluate the clinical effectiveness, efficiency, and cost-effectiveness of a personalized medicine strategy based on pre-emptive pharmacogenetic testing in patients with depressive disorder who are initiating a new antidepressant therapy - SNRIs, SSRIs, or TCAs- after prior treatment failure.
 Randomised Controlled Single [{"id":179199,"code":1,"name":"Subject"}] Intervention arm: where antidepressant treatment will be guided by a personalized medicine strategy that integrates pre-emptive pharmacogenetic testing with individual clinical, demographic, and concomitant medication data. This information will be presented through a web-based clinical decision-support tool and reviewed by an experienced clinical pharmacologist who will provide tailored therapeutic recommendations. Treating physicians will have access to these recommendations to support their decision-making.
Control arm: where antidepressant treatment will be selected empirically by the treating physician, following standard clinical practice and the drug's product labeling. No pharmacogenetic information will be available to guide therapeutic decisions.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

  1. 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.
  2. Voluntary signing of the informed consent form (ICF).
  3. Age += 18 years at the time of signing the ICF.
  4. Ability and willingness to participate and follow the study for the majority of its duration.
  5. 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.
  6. 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.
  7. 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.
  8. No prior genotyping for CYP3A4, SLC6A4, HTR2A, CYP2D6, CYP2B6, or CYP2C19 genes.
  9. 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 12

  1. Reports suicidal thoughts nearly every day, based on PHQ-9 item 9.
  2. History of failure to respond or intolerance to more than one prior antidepressant treatment line for the current depressive episode.
  3. 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.
  4. 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.
  5. 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.
  6. Patients with a documented history of antidepressant treatment prescribed for Adjustment Disorder, Generalized Anxiety Disorder (GAD), or Post-Traumatic Stress Disorder (PTSD).
  7. Currently hospitalized for psychiatric or medical reasons.
  8. Have a known active drug substance abuse.
  9. Pregnant or breastfeeding women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
  10. Participants are unwilling or unable to comply with all scheduled visits, the treatment plan, laboratory tests, lifestyle considerations, or other study procedures.
  11. Any condition or situation that precludes or interferes with compliance with the protocol.
  12. The participant is currently enrolled in or has enrolled in a clinical trial within the three months preceding inclusion in the current study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 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 endpoints 13

  1. 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)
  2. 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.
  3. Incremental cost-effectiveness ratios (ICERs), comparing cost differences relative to differences in clinical efficacy between the two arms.
  4. Total number of adverse events (AEs) in each cohort.
  5. Total number of hospitalizations per arm.
  6. Total number of clinical visits (scheduled and unscheduled).
  7. Total number of non-scheduled psychiatric consultations in each arm.
  8. Total number of participants with symptom remission remains at the end of the 16-week follow-up period.
  9. Total costs in the intervention arm (including pharmacogenetic testing and clinical event costs) versus total costs related to clinical events in the control arm.
  10. Incremental cost of pharmacogenetic testing and associated implementation procedures.
  11. Total number of serious adverse events (SAEs) in each cohort.
  12. Total number of dropouts due to SAEs.
  13. Incidence of adverse events of special interest: Suicidal ideation, Suicide attempt, Serotonin syndrome, and Neuroleptic malignant syndrome.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 20

Venlafaxina Retard Sandoz 75 mg cápsulas duras de liberación prolongada EFG

PRD7496312 · Product

Active substance
Venlafaxine Hydrochloride
Substance synonyms
(RS)-1-(2-DIMETHYLAMINO-1-P-METHOXYPHENYLETHYL)CYCLOHEXANOL HYDROCHLORIDE, 1[2DIMETHYLAMINO1(4METHOXYPHENYL)ETHYL]CYCLOHEXAN1OL HYDROCHLORIDE
Pharmaceutical form
PROLONGED-RELEASE CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
375 mg milligram(s)
Max total dose
42000 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AX16 — VENLAFAXINE
Marketing authorisation
84220
MA holder
SANDOZ FARMACÉUTICA, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Valdoxan 25 mg film-coated tablets

PRD10829823 · Product

Active substance
Agomelatine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
50 mg milligram(s)
Max total dose
5600 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AX22 — -
Marketing authorisation
EU/1/08/499/002
MA holder
LES LABORATOIRES SERVIER (SURESNES)
MA country
Iceland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Duloxetina Eignapharma 30 mg cápsulas duras gastrorresistentes EFG

PRD8867561 · Product

Active substance
Duloxetine
Pharmaceutical form
GASTRO-RESISTANT CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
120 mg milligram(s)
Max total dose
13440 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AX21 — -
Marketing authorisation
85900
MA holder
EIGNAPHARMA SLU
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Surmontil 25 mg comprimidos recubiertos con película

PRD10626541 · Product

Active substance
Trimipramine Maleate
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
400 mg milligram(s)
Max total dose
44800 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AA06 — TRIMIPRAMINE
Marketing authorisation
40115
MA holder
NEURAXPHARM SPAIN, S.L.U.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Anafranil 10 mg comprimidos recubiertos

PRD6439683 · Product

Active substance
Clomipramine Hydrochloride
Pharmaceutical form
COATED TABLET
Route of administration
ORAL USE
Max daily dose
250 mg milligram(s)
Max total dose
28000 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AA04 — CLOMIPRAMINE
Marketing authorisation
49.656
MA holder
ALFASIGMA S.P.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluvoxamina Sandoz 50 mg comprimidos recubiertos con pelicula EFG

PRD2784849 · Product

Active substance
Fluvoxamine Maleate
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
300 mg milligram(s)
Max total dose
33600 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AB08 — FLUVOXAMINE
Marketing authorisation
63.276
MA holder
SANDOZ FARMACÉUTICA, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sertralina cinfa 150 mg comprimidos recubiertos con película

PRD11430925 · Product

Active substance
Sertraline
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
200 mg milligram(s)
Max total dose
22400 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AB06 — SERTRALINE
Marketing authorisation
84732
MA holder
LABORATORIOS CINFA S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fluoxetina Viatris 20 mg cápsulas duras EFG

PRD9854053 · Product

Active substance
Fluoxetine
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
60 mg milligram(s)
Max total dose
6720 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AB03 — FLUOXETINE
Marketing authorisation
62661
MA holder
VIATRIS LIMITED
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Desvenlafaxina cinfa 50 mg comprimidos de liberación prolongada EFG

PRD9640568 · Product

Active substance
Desvenlafaxine
Pharmaceutical form
PROLONGED-RELEASE TABLET
Route of administration
ORAL USE
Max daily dose
200 mg milligram(s)
Max total dose
22400 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AX23 — -
Marketing authorisation
86783
MA holder
LABORATORIOS CINFA, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Quetiapina NORMON 300 mg comprimidos recubiertos con película EFG

PRD397705 · Product

Active substance
Quetiapine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
600 mg milligram(s)
Max total dose
67200 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N05AH04 — QUETIAPINE
Marketing authorisation
71557
MA holder
LABORATORIOS NORMON, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

escitalopram cinfa 10 mg comprimidos recubiertos con película EFG

PRD542803 · Product

Active substance
Escitalopram
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
20 mg milligram(s)
Max total dose
2240 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AB10 — ESCITALOPRAM
Marketing authorisation
71.430
MA holder
LABORATORIOS CINFA, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vortioxetina Kern Pharma 5 mg comprimidos recubiertos con película EFG

PRD11162410 · Product

Active substance
Vortioxetine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
20 mg milligram(s)
Max total dose
2240 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AX26 — -
Marketing authorisation
89.389
MA holder
KERN PHARMA, S.L.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

mirtazapina cinfa 30 mg comprimidos recubiertos con película EFG

PRD542961 · Product

Active substance
Mirtazapine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
45 mg milligram(s)
Max total dose
5040 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AX11 — MIRTAZAPINE
Marketing authorisation
67.068
MA holder
LABORATORIOS CINFA, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

TOFRANIL 10 mg comprimidos recubiertos

PRD791262 · Product

Active substance
Imipramine Hydrochloride
Pharmaceutical form
COATED TABLET
Route of administration
ORAL USE
Max daily dose
200 mg milligram(s)
Max total dose
22400 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AA02 — IMIPRAMINE
Marketing authorisation
40.366
MA holder
AMDIPHARM LIMITED
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Norfenazin “25”®

PRD8136468 · Product

Active substance
Nortriptyline Hydrochloride
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
150 mg milligram(s)
Max total dose
16800 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AA10 — NORTRIPTYLINE
Marketing authorisation
48463
MA holder
BIOWISE PHARMACEUTICALS, S.L.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lantanon 10 mg comprimidos recubiertos con película

PRD8943468 · Product

Active substance
Mianserin Hydrochloride
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
90 mg milligram(s)
Max total dose
10080 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AX03 — MIANSERIN
Marketing authorisation
54.407
MA holder
ORGANONSALUD, S.L.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Amitriptyline hydrochloride 25 mg film-coated tablets

PRD11683614 · Product

Active substance
Amitriptyline Hydrochloride
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
150 mg milligram(s)
Max total dose
16800 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AA09 — AMITRIPTYLINE
Marketing authorisation
PL 49445/0218
MA holder
AMAROX LIMITED
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Bupropión Sandoz 150 mg comprimidos de liberación modificada EFG.

PRD3373811 · Product

Active substance
Bupropion Hydrochloride
Substance synonyms
AMFEBUTAMONE HYDROCHLORIDE
Pharmaceutical form
MODIFIED-RELEASE TABLET
Route of administration
ORAL
Max daily dose
300 mg milligram(s)
Max total dose
33600 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AX12 — BUPROPION
Marketing authorisation
79848
MA holder
SANDOZ FARMACÉUTICA, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Citalopram Normon 20 mg comprimidos recubiertos con película EFG

PRD398228 · Product

Active substance
Citalopram Hydrobromide
Substance synonyms
1-(3-DIMETHYLAMINOPROPYL)-1-(4-FLUOROPHENYL)-3H-2-BENZOFURAN-5-CARBONITRILE HYDROBROMIDE, NITALAPRAM HYDROBROMIDE
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
40 mg milligram(s)
Max total dose
4480 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AB04 — CITALOPRAM
Marketing authorisation
66795
MA holder
LABORATORIOS NORMON, S.A.
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

PAROXETINA 20 mg comprimidos recubiertos con película EFG

PRD10278258 · Product

Active substance
Paroxetine
Pharmaceutical form
FILM-COATED TABLET
Route of administration
OCULAR USE
Max daily dose
50 mg milligram(s)
Max total dose
5600 mg milligram(s)
Max treatment duration
16 Week(s)
Authorisation status
Authorised
ATC code
N06AB05 — PAROXETINE
Marketing authorisation
64365
MA holder
VIATRIS LIMITED
MA country
Spain
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz

11 Total trials 2 Recruiting 5 Ended
Academic / Non-commercial
Sponsor organisation
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Address
Paseo De La Castellana 261
City
Madrid
Postcode
28046
Country
Spain

Scientific contact point

Organisation
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Contact name
Alberto Manuel Borobia Pérez

Public contact point

Organisation
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Contact name
Alberto Manuel Borobia Pérez

Locations

1 EU/EEA country · 5 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Authorised, recruitment pending 240 5
Rest of world — 0 —

Investigational sites

Spain

5 sites · Authorised, recruitment pending
Hospital Universitario La Paz
Psiquiatría, Paseo De La Castellana 261, 28046, Madrid
Centro de Salud Mental Tetuán
Psiquiatría, C/ Dr. Cecilio de la Morena Arranz, 2, Madrid
Hospital Dr. R Lafora
Psiquiatría, Carretera Del Colmenar Viejo Km 13800, Por El Pardo, Madrid
Centro de Salud Mental Fuencarral
Psiquiatría, CALLE MELCHOR FERNANDEZ ALMAGRO, 1, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Clinical Pharmacology, Calle De Joaquin Dicenta 2, 28029, Madrid

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 26 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) iPHARMGx Master Protocol MNR1 v1_0 Final_redacted 1.0 MNS1
Protocol (for publication) PREDICT_protocol_redacted 1.1.
Recruitment arrangements (for publication) PREDICT_Recruitment procedure 1
Subject information and informed consent form (for publication) PREDICT_HIP_CI 1.1
Summary of Product Characteristics (SmPC) (for publication) Agomelatina_FT 1
Summary of Product Characteristics (SmPC) (for publication) Amitriptilina _FT 1
Summary of Product Characteristics (SmPC) (for publication) Bupropion_FT 1
Summary of Product Characteristics (SmPC) (for publication) Citalopram_FT 1
Summary of Product Characteristics (SmPC) (for publication) Clomipramina_FT 1
Summary of Product Characteristics (SmPC) (for publication) Desvenlafaxina_FT 1
Summary of Product Characteristics (SmPC) (for publication) Duloxetina_FT 1
Summary of Product Characteristics (SmPC) (for publication) Escitalopram_FT 1
Summary of Product Characteristics (SmPC) (for publication) Fluoxetina_FT 1
Summary of Product Characteristics (SmPC) (for publication) Fluvoxamina_FT 1
Summary of Product Characteristics (SmPC) (for publication) Imipramina_FT 1
Summary of Product Characteristics (SmPC) (for publication) Mianserina_FT 1
Summary of Product Characteristics (SmPC) (for publication) Mirtazapina_FT 1
Summary of Product Characteristics (SmPC) (for publication) Nortriptilina_FT 1
Summary of Product Characteristics (SmPC) (for publication) Paroxetina_FT 1
Summary of Product Characteristics (SmPC) (for publication) Quetiapina_FT 1
Summary of Product Characteristics (SmPC) (for publication) Sertralina_FT 1
Summary of Product Characteristics (SmPC) (for publication) Trimipramina_FT 1
Summary of Product Characteristics (SmPC) (for publication) Venlafaxina_FT 1
Summary of Product Characteristics (SmPC) (for publication) Vortioxetina_FT 1
Synopsis of the protocol (for publication) PREDICT_Resumen del Protocolo_ES 1.0
Synopsis of the protocol (for publication) PREDICT_Summary_EN 1.0

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-09-22 Spain Acceptable
2025-12-22
 2026-01-11
2 SUBSTANTIAL MODIFICATION SM-1 2026-03-31 Spain Acceptable 2026-04-16

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