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Real-World study tracks Trazodone's effect on depression and memory in seniors

NCT ID NCT07377682

Knowledge-focused Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is observing how the medication trazodone helps older adults (55+) who have both major depression and mild memory or thinking problems. Researchers will track changes in depression symptoms and thinking skills during routine care in Italy, Poland, and Romania. The goal is to understand how well trazodone works in everyday medical practice, not to test a new drug.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with Major Depressive Disorder and mild cognition impairment treated with trazodone

Ages

55 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged 55 or older. * Patients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for MDD diagnosis. * Patients experiencing a current major depressive episode of at least moderate severity, defined by a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥20 at enrolment. * Patients with a diagnosis of MCI (also referred to as "mild neurocognitive disorder") according to the DSM-5 criteria. * Patients who start treatment with trazodone hydrochloride (prolonged release) with starting dosage according to SmPC at enrolment visit (or at latest within one week). * Patients legally capable of giving their written consent to participate in the study (including personal data processing) and willing to comply with all study procedures as per clinical judgement. Exclusion Criteria: * Patients who meet any of the contraindications to the administration of trazodone according to the approved local SmPC. * Known hypersensitivity or allergy to the active ingredient and/or to any component of the study medication. * Concomitant treatment with other antidepressant drugs, mood stabilizers, antipsychotics, and/or proved resistance to trazodone monotherapy. * Patients 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. * Patients with previous or current history of any neurological condition that, in the opinion of the Investigator, might compromise participation in the study. * Patients participating in any interventional study in the 30 days prior to the enrolment visit. * Patients with ongoing pregnancy or breast-feeding at enrolment visit.

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Conditions

The condition(s) this trial relates to.

cognitive disorder Depression major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cognition disorders in old age Depression - major depressive disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Poradnia Medycyna Miłorząb: pl. Pokoju 3/4, 90-227 Łódź. Poland

    RECRUITING

    Lodz, Poland, 93-005, Poland

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