Safety of Liposom With Citalopram in Elderly Patients With Major Depressive Disorder
NCT ID: NCT04975724
Last Updated: 2024-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
150 participants
INTERVENTIONAL
2019-04-18
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A Liposom Forte + Citalopram
Liposom Forte (2 ampoules of 28mg/2 ml) for 30 days + citalopram (10mg) for 90 days
Liposom Forte
Liposom Forte 28mg/2ml solution for injection contains a mixture of purified hypothalamic phospholipids (PLs) from swine brains. The key components of the phospholipid mixture are phosphatidylcholine (PC), phosphatidylethanolamine (PE) and phosphatidylserine (PS).
Citalopram
The medicinal product Citalopram Aurobindo contains citalopram as active ingredient available on the market in 20 mg film coated tablets. The tablets are divisible in two equal part of 10 mg as reported in the SmPC
Group B Placebo + Citalopram
Placebo (2 ampoules of 2 ml) for 30 days + citalopram (10mg) for 90 days
Citalopram
The medicinal product Citalopram Aurobindo contains citalopram as active ingredient available on the market in 20 mg film coated tablets. The tablets are divisible in two equal part of 10 mg as reported in the SmPC
Placebo
Liposom Forte Placebo (2 ampoules of 2 ml solution for injection)
Interventions
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Liposom Forte
Liposom Forte 28mg/2ml solution for injection contains a mixture of purified hypothalamic phospholipids (PLs) from swine brains. The key components of the phospholipid mixture are phosphatidylcholine (PC), phosphatidylethanolamine (PE) and phosphatidylserine (PS).
Citalopram
The medicinal product Citalopram Aurobindo contains citalopram as active ingredient available on the market in 20 mg film coated tablets. The tablets are divisible in two equal part of 10 mg as reported in the SmPC
Placebo
Liposom Forte Placebo (2 ampoules of 2 ml solution for injection)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
65 Years
84 Years
ALL
No
Sponsors
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Fidia Farmaceutici s.p.a.
INDUSTRY
Responsible Party
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Principal Investigators
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Nicola Giordan
Role: STUDY_DIRECTOR
Fidia Farmaceutici s.p.a.
Locations
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UOC Geriatria e Lungodegenza Geriatrica PO San Filippo e Nicola di Avezzano - ASL1 Avezzano Sulmona L'aquila
Avezzano, , Italy
UO Psichiatria - ASST Papa Giovanni XXIII
Bergamo, , Italy
Ambulatorio Psichiatrico, UOC Psichiatria Presidio Ospedaliero di Codogno - ASST Lodi
Codogno, , Italy
SOD Geriatria-UTIG Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Servizio Psichiatrico di Diagnosi e Cura (SPDC) Foggia, Ospedali Riuniti di Foggia
Foggia, , Italy
Servizio Psichiatrico di Diagnosi e Cura (SPDC) - ASL3 Ente Ospedaliero Ospedali Galliera
Genova, , Italy
Ambulatorio Clinica Psichiatrica, Ospedale Policlinico S. Martino
Genova, , Italy
UOC Geriatria PO San Salvatore - ASL1 Avezzano Sulmona L'Aquila
L’Aquila, , Italy
SPDC Ospedale Fatebenefratell, UOC Psichiatria 1 ASST Fatebenefratelli Sacco
Milan, , Italy
Centro Depressione Anziani S.C. Psichiatria 51, ASST Santi Paolo e Carlo - Presidio San Paolo
Milan, , Italy
UOC Psichiatria - Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, , Italy
Clinica Psichiatrica, Azienda Sanitaria Universitaria Integrata di Udine
Udine, , Italy
Countries
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Central Contacts
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Facility Contacts
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Giovambattista Desideri
Role: primary
Bernardo Dell'Osso
Role: primary
Simone Cavallotti
Role: primary
Matteo Balestrieri
Role: primary
Other Identifiers
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QQ05.16.02
Identifier Type: -
Identifier Source: org_study_id
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