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Taking people in ItalyPhase 4

Tests Liposom with citalopram for depression in older adults

Tests whether Liposom speeds up response to citalopram in older adults with depression.

Key facts

Who runs it
Fidia Farmaceutici S.p.A.
Where
Avezzano, Milan, and Rome, ItalySee the 3 sites
Registry title
A randomized, double-blind, placebo-controlled, multicenter clinical trial to assess safety and effectiveness of Liposom in enhance and speed up response to antidepressant therapy with citalopram in elderly patients suffering from Major Depressive Disorder (MDD)
Status
Recruiting
Phase
Phase 4
People taking part
150 people, planned
Started
10 Dec 2018
Planned end
31 Dec 2025
Type of study
Interventional, 2 groups
Record updated
23 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. 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 people aged 65 or older with major depressive disorder. It tests whether Liposom Forte helps citalopram work better.

Age
65 years or older
Sex
All sexes can join
Disease stage
Major depressive disorder meeting DSM-V criteria, with a HAM-D score of 16 or more and an MMSE-2 score of 23 or more
Earlier treatment
No antipsychotics, antidepressants, food supplements (such as St. John's Wort) or over-the-counter CNS-active medicines in the 2 weeks before the first study dose. No MAOIs in the 3 weeks before. No long acting injectable antipsychotics in the 6 months before.

Main reasons for not taking part

  • Dementia (major neurocognitive disorder)
  • Diabetes type I or II
  • Current suicidal thoughts, or a suicide attempt in the past year
  • Heart conditions such as congenital long QT syndrome, severe bradycardia, recent heart attack or uncompensated heart failure
  • Other psychiatric disorders, substance use disorder, or psychotic symptoms

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • Meets DSM-V criteria for major depressive disorder
  • Score of ≥ 16 in the HAM-D
  • Score of ≥ 23 on the Mini-Mental State Exam (MMSE-2)
  • Aged ≥ 65 years
  • Patients able to understand the study procedures and to comply with protocol requirements
  • Patients legally able to give written informed consent to the trial (signed and dated by the subject)

Who cannot take part

  • Treated with any antipsychotics, antidepressant, food supplements (St. John's Wort) or over-the-counter CNS-active medications within 2 weeks prior to the first administration of study medication, with the exception of MAOIs, for which the treatment is not permitted in the 3 weeks prior to the first administration of study medication
  • Acute suicidal or violent behaviour or history of suicide attempt within the year prior to study entry or current suicidal ideation
  • Treated with long acting injectable (LAI) antipsychotics within 6 months prior to study entry
  • History of psychiatric disorder other than major depressive disorder, including history of substance use disorder
  • Presence of psychotic symptoms, even if they are not sufficient to make diagnosis of a mental disorder
  • Severe uncompensated and/or acute organic disease or any other medical condition which may interfere with the aim of the study or with the subject health and well-being
  • Major neurocognitive disorders (also called dementia)
  • Diabetes Mellitus type I and II
  • Congenital long QT syndrome, severe bradycardia, recent acute myocardial infarction, uncompensated heart failure or concomitant use of drugs that prolong the QT interval
  • Any contraindication for treatment or intolerance to Liposom Forte or citalopram
  • Ongoing psychotherapy or other psychological treatment during the study period

Where in Italy

  • PO San Filippo e Nicola di Avezzano - ASL1 Avezzano Sulmona L'AquilaAvezzano, ItalyTaking people
  • ASST Fatebenefratelli SaccoMilan, ItalyTaking people
  • Azienda Ospedaliero-Universitaria Sant AndreRome, ItalyTaking people

About the trial

What the trial wants to find out

The purpose of this study is to determine if Liposom Forte will enhance the response to antidepressant therapy with citalopram in elderly patients suffering from Major Depressive Disorder (MDD).

The 2 groups in the trial

  • Group A Liposom Forte + CitalopramTreatment being tested

    Liposom Forte (2 ampoules of 28mg/2 ml) for 30 days + citalopram (10mg) for 90 days

    Treatment: Liposom Forte and Citalopram

  • Group B Placebo + CitalopramTreatment being tested

    Placebo (2 ampoules of 2 ml) for 30 days + citalopram (10mg) for 90 days

    Treatment: Citalopram and Placebo

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A randomized, double-blind, placebo-controlled, multicenter clinical trial to assess safety and effectiveness of Liposom in enhance and speed up response to antidepressant therapy with citalopram in elderly patients suffering from Major Depressive Disorder (MDD)
Plain-language title
Tests Liposom with citalopram for depression in older adultsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
23 December 2025