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2025-523267-38-00Not yet recruitingPhase 4

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

Effectiveness of Trazodone on Emotional Blunting in Patients with Major Depressive: a Phase IV, Open-label, clinical study

Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Aug 2026

Next steps

Brief summary (registry, in English)

The goal of the study is to evaluate, after 8 weeks of treatment with trazodone, the improvement in the experience, expression and regulation of positive and negative emotions in patients with MDD that have been previously treated with SSRIs/SNRIs but have not shown a complete response.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
120 (estimated)
First submitted
3 Apr 2026
Start date
31 Jul 2026
Lead sponsor
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.
Diseases
Depression
EU CT number
2025-523267-38-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 120
  • 9 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult outpatients with major depressive disorder who did not fully respond to an SSRI or SNRI and still have emotional blunting. They will switch to trazodone for 8 weeks.

Age
18-65 years (the registry also lists a maximum age of 64 years)
Sex
Women and men can join.
Disease stage
Single or recurrent major depressive disorder. The current episode has lasted less than 12 months. MADRS total score from 22 to 28 at the first visit.
Earlier treatment
Must have taken an SSRI or SNRI alone for at least 6 weeks at an adequate dose, with an inadequate response, and be a candidate for a switch. Cannot have had an inadequate response to two previous antidepressant courses.
Biomarker or test result
ODQ total score of 50 or more while on the SSRI/SNRI.

Main reasons for not taking part

  • Bipolar disorder, schizophrenia or other psychotic disorder, or severe personality disorder
  • Taking antipsychotics or mood stabilizers
  • Risk of suicide (MADRS item 10 score of 4 or more)
  • Known heart disease, including QT interval prolongation
  • Pregnancy or breastfeeding

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Lab values

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (9)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Multiprofile Hospital For Active Treatment Dr. Hristo Stambolski EOODKazanlikBulgariaNot yet recruiting
Ambulatory For Group Practice For Specialized Psychiatric Help Philipopolis Ltd.PlovdivBulgariaNot yet recruiting
Mental Health Center Sofia EOODSofiaBulgariaNot yet recruiting
Clinexpert Gyoengyoes Kft.GyongyosHungaryNot yet recruiting
University of PecsPécsHungaryNot yet recruiting
E4r&D Sp. z o.o.GdanskPolandNot yet recruiting
Centrum Zdrowia AlceaGdanskPolandNot yet recruiting
Clinic BBP Sp z o oKatowicePolandNot yet recruiting
Clinical Medical Research Sp. z o.o.KatowicePolandNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.