Enhancing antidepressant therapy in elderly patients with depression
A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Trial to Assess Safety and Effectiveness of Liposom in Enhance and Speed up Response With Citalopram in Elderly Patients Suffering From Major Depressive Disorder (MDD)
This study is testing if adding Liposom Forte to the antidepressant citalopram can help older adults with depression feel better faster and with fewer side effects.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 65 Years to 84 Years |
| Sex | All |
| Sponsor | Fidia Farmaceutici s.p.a. Industry-sponsored |
| Locations | 12 sites (Avezzano and 11 other locations) |
| Trial ID | NCT04975724 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety and efficacy of Liposom Forte in combination with citalopram for elderly patients diagnosed with Major Depressive Disorder (MDD). It investigates whether the addition of phospholipid liposomes can improve the therapeutic response and reduce the onset time of antidepressant effects. The study will measure improvements in depressive symptoms using the Hamilton Rate Scale for Depression and assess the potential for lower doses of citalopram to minimize adverse effects. Participants will be monitored for their response to this combination therapy compared to a placebo.
Who should consider this trial
Good fit: Ideal candidates are elderly individuals aged 65 to 85 who meet the criteria for major depressive disorder and can provide informed consent.
Not a fit: Patients with contraindications to Liposom Forte or citalopram, or those with severe psychiatric or organic diseases, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer treatment options for elderly patients suffering from depression.
How similar studies have performed: While the use of liposomes in antidepressant therapy is a novel approach, previous studies have shown promising results with similar methodologies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Meets DSM-V criteria for major depressive disorder 2. Score of ≥ 16 in the HAM-D 3. Score of ≥ 23 on the Mini-Mental State Exam (MMSE-2) 4. Aged ≥ 65 and \< 85 years 5. Patients able to understand the study procedures and to comply with protocol requirements 6. Patients legally able to give written informed consent to the trial (signed and dated by the subject) Exclusion Criteria: 1. Any contraindication for treatment or intolerance to Liposom Forte or citalopram 2. Congenital long QT syndrome, bradycardia, recent acute myocardial infarction, uncompensated heart failure or concomitant use of drugs that prolong the QT interval 3. History of psychiatric disorder other than major depressive disorder, including history of substance use disorder 4. Presence of psychotic symptoms, even if they are not sufficient to make diagnosis of a mental disorder 5. Severe organic disease (e.g., major surgery, metastatic cancer, stroke, delirium, severe neurological disorder, heart attack, chronic heart failure, asthma, severe cardio circulatory disorders) 6. Diabetes Mellitus type I and II 7. Acute suicidal or violent behaviour or history of suicide attempt within the year prior to study entry or current suicidal ideation 8. Treated with long acting injectable (LAI) antipsychotics within 6 months prior to study entry 9. Treated with any antipsychotics, antidepressant, food supplements or over-the-counter CNS-active medications (e.g, St. John's Wort, melatonin, Selective Serotonin Reuptake Inhibitors \[SSRIs\], Serotonin and norepinephrine reuptake inhibitors \[SNRIs\], Monoamine-Oxidase Inhibitors \[MAOIs\], or other antidepressants) within 4 weeks prior to the first administration of study medication 10. Ongoing or planned psychotherapy or other psychological treatment during the study period
Where this trial is running
Avezzano and 11 other locations
- UOC Geriatria e Lungodegenza Geriatrica PO San Filippo e Nicola di Avezzano - ASL1 Avezzano Sulmona L'aquila — Avezzano, Italy (Recruiting)
- UO Psichiatria - ASST Papa Giovanni XXIII — Bergamo, Italy (Active_not_recruiting)
- Ambulatorio Psichiatrico, UOC Psichiatria Presidio Ospedaliero di Codogno - ASST Lodi — Codogno, Italy (Active_not_recruiting)
- SOD Geriatria-UTIG Azienda Ospedaliero-Universitaria Careggi — Firenze, Italy (Active_not_recruiting)
- Servizio Psichiatrico di Diagnosi e Cura (SPDC) Foggia, Ospedali Riuniti di Foggia — Foggia, Italy (Active_not_recruiting)
- Servizio Psichiatrico di Diagnosi e Cura (SPDC) - ASL3 Ente Ospedaliero Ospedali Galliera — Genova, Italy (Active_not_recruiting)
- Ambulatorio Clinica Psichiatrica, Ospedale Policlinico S. Martino — Genova, Italy (Active_not_recruiting)
- UOC Geriatria PO San Salvatore - ASL1 Avezzano Sulmona L'Aquila — L'Aquila, Italy (Active_not_recruiting)
- SPDC Ospedale Fatebenefratell, UOC Psichiatria 1 ASST Fatebenefratelli Sacco — Milano, Italy (Recruiting)
- Centro Depressione Anziani S.C. Psichiatria 51, ASST Santi Paolo e Carlo - Presidio San Paolo — Milano, Italy (Recruiting)
- UOC Psichiatria - Azienda Ospedaliero-Universitaria Sant'Andrea — Roma, Italy (Active_not_recruiting)
- Clinica Psichiatrica, Azienda Sanitaria Universitaria Integrata di Udine — Udine, Italy (Recruiting)
Study contacts
- Study coordinator: Nicola Giordan, Dr
- Email: ngiordan@fidiapharma.it
- Phone: 0039 049 8232512
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.