Tests Liposom with citalopram for depression in older adults
Tests whether Liposom speeds up response to citalopram in older adults with depression.
Plain-language title generated from the registry record
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)
Key facts
- Where
- Avezzano, Milan, and Rome, ItalySee the 3 sites
- Phase
- Phase 4
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
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fidia Farmaceutici S.p.A.
- Trial code
- NCT04975724EU 2024-512293-10-00
- Record updated
- 23 December 2025
- Original description
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).Read full original descriptionShow less
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)
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).
Inclusion: 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).
Exclusion: 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.