Safety of Liposom With Citalopram in Elderly Patients With Major Depressive Disorder

PHASE4RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

April 18, 2019

Primary Completion Date

October 31, 2025

Study Completion Date

December 31, 2025

Conditions
Major Depressive Disorder
Interventions
DRUG

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).

DRUG

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

OTHER

Placebo

Liposom Forte Placebo (2 ampoules of 2 ml solution for injection)

Trial Locations (12)

16128

ACTIVE_NOT_RECRUITING

Servizio Psichiatrico di Diagnosi e Cura (SPDC) - ASL3 Ente Ospedaliero Ospedali Galliera, Genova

16132

ACTIVE_NOT_RECRUITING

Ambulatorio Clinica Psichiatrica, Ospedale Policlinico S. Martino, Genova

20121

RECRUITING

SPDC Ospedale Fatebenefratell, UOC Psichiatria 1 ASST Fatebenefratelli Sacco, Milan

20142

RECRUITING

Centro Depressione Anziani S.C. Psichiatria 51, ASST Santi Paolo e Carlo - Presidio San Paolo, Milan

24127

ACTIVE_NOT_RECRUITING

UO Psichiatria - ASST Papa Giovanni XXIII, Bergamo

26845

ACTIVE_NOT_RECRUITING

Ambulatorio Psichiatrico, UOC Psichiatria Presidio Ospedaliero di Codogno - ASST Lodi, Codogno

33100

RECRUITING

Clinica Psichiatrica, Azienda Sanitaria Universitaria Integrata di Udine, Udine

50100

ACTIVE_NOT_RECRUITING

SOD Geriatria-UTIG Azienda Ospedaliero-Universitaria Careggi, Florence

67051

RECRUITING

UOC Geriatria e Lungodegenza Geriatrica PO San Filippo e Nicola di Avezzano - ASL1 Avezzano Sulmona L'aquila, Avezzano

67100

ACTIVE_NOT_RECRUITING

UOC Geriatria PO San Salvatore - ASL1 Avezzano Sulmona L'Aquila, L’Aquila

71122

ACTIVE_NOT_RECRUITING

Servizio Psichiatrico di Diagnosi e Cura (SPDC) Foggia, Ospedali Riuniti di Foggia, Foggia

00189

ACTIVE_NOT_RECRUITING

UOC Psichiatria - Azienda Ospedaliero-Universitaria Sant'Andrea, Roma

Sponsors
All Listed Sponsors
lead

Fidia Farmaceutici s.p.a.

INDUSTRY