NCT04975724RecruitingPhase 4
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 23 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 10 Oct 2024
- Start date
- 10 Dec 2018
- Lead sponsor
- Fidia Farmaceutici S.p.A.
- Diseases
- Depression
- NCT number
- NCT04975724
- EU CT number
- 2024-512293-10-00
- EudraCT number
- 2018-001622-26
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- 3 sites in 1 country
- 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, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Lab values
- Congenital long QT syndrome, severe bradycardia, recent acute myocardial infarction, uncompensated heart failure or concomitant use of drugs that prolong the QT interval
Other
- Any contraindication for treatment or intolerance to Liposom Forte or citalopram
- Ongoing psychotherapy or other psychological treatment during the study period
Who the study is looking for
- 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)
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PO San Filippo e Nicola di Avezzano - ASL1 Avezzano Sulmona L'Aquila Coordinator of this site? Confirm its status | Avezzano | Italy | Recruiting |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Sant Andre Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.