Depression and Anxiety Trial, Recruiting NCT07377682 Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A Condition: Depression and Anxiety
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Depression and Anxiety Trial, Recruiting

NCT07377682
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 55 or older.
  • People who have been diagnosed with Major Depressive Disorder (MDD) according to standard medical diagnostic guidelines (DSM-5).
  • People who are currently experiencing a depressive episode that is at least moderate in severity, based on a specific depression rating scale score measured at the time of enrolment.
  • People who have also been diagnosed with Mild Cognitive Impairment (MCI) — sometimes called "mild neurocognitive disorder" — according to standard medical diagnostic guidelines (DSM-5).
  • People who are starting treatment with a medication called trazodone hydrochloride (prolonged release) at enrolment, or within one week of joining.
  • People who are legally able to give written consent to participate and are willing to follow all study procedures, as assessed by a clinician.

Who may not be able to join:

  • People for whom trazodone is medically contraindicated according to the approved medication guidelines (confirm with trial site).
  • People with a known allergy or sensitivity to trazodone or any of its ingredients.
  • People who are currently taking other antidepressants, mood stabilisers, or antipsychotic medications, or who have previously tried trazodone alone without benefit.
  • People who have a current diagnosis of bipolar disorder, schizophrenia, another psychotic disorder, severe personality disorder, intellectual disability, or a mental disorder caused by another medical condition.
  • People with a past or current neurological condition that the trial investigator considers could affect their ability to safely participate.
  • People who have taken part in another interventional clinical trial within the 30 days before enrolment.
  • People who are currently pregnant or breastfeeding at the time of enrolment.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Raffaele Antonelli Incalzi, CAMPUS BioMedico

Phone: +393475665012

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Registry
ClinicalTrials.gov
Start date
15 December 2025
Est. completion
1 July 2026

Where this trial is recruiting

🇵🇱 Poland

Primary endpoints

Depressive symptoms severity (MADRS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov