Trials Sponsors Conditions Drugs Pricing

Conditions

Major depressive disorder (MDD)

Outcome Measures

Primary Outcomes (1)

During the study, participants will record the answers given to a questionnaire designed to measure emotional experiences, called Oxford Depression Questionnaire (ODQ). The outcome will be measured by the changes in the score recorded at the beginning of patients’ participation compared to the one after 8 weeks of treatment.

Secondary Outcomes (1)

Other parameters evaluated will be the evolution of depression and the effect on cognition, sleep, and overall quality of life. The effect of the treatment on functioning at work or school, in social situations, or with family and home responsibilities will be also assessed using scales and questionnaires designed for these purposes.

Interventions

Trittico AC 150 mg retard tablettaType not reported

TRITTICO CR, 75 mg, tabletki o przedłużonym uwalnianiuType not reported

ТРИТИКО 150 mg таблетки с удължено освобождаване

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
Trittico AC 150 mg retard tabletta
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
PROLONGED-RELEASE TABLET
View registry record
Formulated product
TRITTICO CR, 75 mg, tabletki o przedłużonym uwalnianiu
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
PROLONGED-RELEASE TABLET
View registry record
Formulated product
ТРИТИКО 150 mg таблетки с удължено освобождаване
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
PROLONGED-RELEASE TABLET
View registry record
Formulated product
ТРИТИКО 75 mg таблетки с удължено освобождаване
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
PROLONGED-RELEASE TABLET
View registry record
Formulated product

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

Trittico AC 150 mg retard tabletta
Named ingredient: Trazodone hydrochloride
View registry record
TRITTICO CR, 75 mg, tabletki o przedłużonym uwalnianiu
Named ingredient: Trazodone hydrochloride
View registry record
ТРИТИКО 150 mg таблетки с удължено освобождаване
Named ingredient: Trazodone hydrochloride
View registry record
ТРИТИКО 75 mg таблетки с удължено освобождаване
Named ingredient: Trazodone hydrochloride
View registry record
TRITTICO CR, 150 mg, tabletki o przedłużonym uwalnianiu
Named ingredient: Trazodone hydrochloride
View registry record

Eligibility Criteria

Sexall

Age GroupsAdult (18-64)

You may qualify if:

Male and female outpatients of any ethnic origin aged 18-65 years (limits included) at Baseline visit. 2. Participant has a primary diagnosis of single or recurrent MDD according to DSM-5®. 3. Participant has had the current Major Depressive Episode (MDE) for <12 months. 4. Participant has a MADRS total score ≥ 22 and ≤ 28 at Baseline visit. 5. Participant has been treated with SSRI/SNRI monotherapy (e.g. citalopram, escitalopram, paroxetine, duloxetine, venlafaxine, etc.) for at least 6 weeks at an adequate dose for the current MDE and with an inadequate response and is a candidate for a switch in the Investigator's opinion. 6. Participant has an ODQ total score ≥50 at enrolment visit, while on SSRI/SNRI monotherapy (prior to switch). 7. Written informed consent (including consent for the processing of personal data) signed by participant prior to entering the study following local regulation. 8. Women of childbearing potential must have a negative pregnancy test at Baseline Visit and have to agree not to start a pregnancy from the signature of the informed consent up to the Visit 3, using an appropriate birth control method such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) or Intrauterine hormone releasing System (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence.

Sponsors & Collaborators

Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Enunciabile Anche Angelini Pharma Italia S.p.A. Angelini Pharma S.p.A. A.C.R.A.F. S.p.A. Acraf S.p.A. Angelini S.p.A. aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Industrylead

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Study Sites (9)

Ambulatory For Group Practice For Specialized Psychiatric Help Philipopolis Ltd.

Plovdiv, 4002, Bulgaria

Lyuba Hadzhiyska359888341554 lyuba_hadzhiyska@abv.bg

Mental Health Center Sofia EOOD

Sofia, 1202, Bulgaria

Emil Grashnov359887508204 dr.emo@mail.bg

Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOOD

Kazanlik, 6102, Bulgaria

Ivan Dimitrov35943168328

Central Study Contacts

Valeria Tellone

+393452493461 clinicaltrials@angelinipharma.com

Study Design

Study Type: interventional
Phase: phase 4

Study Record Dates

First Submitted

April 3, 2026

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2025-523267-38-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-29 08:45:33 UTC

Documents

D1_Master protocol 2025-523267-38-00_Publ

You may not qualify if:

Participant who meets any of the contraindications to the administration of the study medication according to the approved local SmPC. 2. Participant with inadequate response to two previous antidepressant treatment courses of adequate dosage and duration. 3. Known hypersensitivity or allergy to the active ingredient and/or to any component of the study medication. 4. Participant with current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, severe personality disorder, mental retardation, organic mental disorders or mental disorders due to a general medical condition. 5. Participant with current history of a clinically significant neurological disorder, or any neurodegenerative disease, or other relevant condition that, in the opinion of the Investigator, might compromise participation in the study. 6. Participant that are under antipsychotics and/or mood stabilizers therapy. 7. Participant at risk of suicide, defined by a score ≥4 in MADRS item #10 at Baseline Visit. 8. Women during pregnancy or lactation period. 9. Clinically significant abnormalities on physical examination and vital signs (as assessed per routine clinical practice) at Baseline Visit which, in the opinion of the Investigator, could interfere with the study procedures or endpoints evaluation. 10. Participant with known cardiovascular disease including those associated with prolongation of the QT interval (e.g. QT Interval Corrected Using Fridericia's Formula (QTcF) value higher than 450 msec for male and QTcF value higher than 470 msec for female). 11. Inability to comply with the protocol requirements (i.e. uncooperative attitude, inability to return to study visits, unlikelihood of completing the clinical study). 12. Participant involved in the conduct of the study (e.g. Investigator or her deputy, first grade relatives, pharmacist, assistant or other personnel). 13. Participation in a interventional clinical trial within 3 months of Baseline Visit.

Evaluation of the efficacy of Trazodone in improving emotional blunting symptoms in Patients with Major Depressive Disorder

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

You may not qualify if:

Locations