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)
Who is this study for? Patients with Major Depressive Disorder
What treatments are being studied? Citalopram
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 84
Healthy Volunteers: f
View:
• 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 and \< 85 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)
Locations
Other Locations
Italy
UOC Geriatria e Lungodegenza Geriatrica PO San Filippo e Nicola di Avezzano - ASL1 Avezzano Sulmona L'aquila
RECRUITING
Avezzano
UO Psichiatria - ASST Papa Giovanni XXIII
ACTIVE_NOT_RECRUITING
Bergamo
Ambulatorio Psichiatrico, UOC Psichiatria Presidio Ospedaliero di Codogno - ASST Lodi
ACTIVE_NOT_RECRUITING
Codogno
SOD Geriatria-UTIG Azienda Ospedaliero-Universitaria Careggi
ACTIVE_NOT_RECRUITING
Florence
Servizio Psichiatrico di Diagnosi e Cura (SPDC) Foggia, Ospedali Riuniti di Foggia
ACTIVE_NOT_RECRUITING
Foggia
Ambulatorio Clinica Psichiatrica, Ospedale Policlinico S. Martino
ACTIVE_NOT_RECRUITING
Genova
Servizio Psichiatrico di Diagnosi e Cura (SPDC) - ASL3 Ente Ospedaliero Ospedali Galliera
ACTIVE_NOT_RECRUITING
Genova
UOC Geriatria PO San Salvatore - ASL1 Avezzano Sulmona L'Aquila
ACTIVE_NOT_RECRUITING
L’aquila
Centro Depressione Anziani S.C. Psichiatria 51, ASST Santi Paolo e Carlo - Presidio San Paolo
RECRUITING
Milan
SPDC Ospedale Fatebenefratell, UOC Psichiatria 1 ASST Fatebenefratelli Sacco
RECRUITING
Milan
UOC Psichiatria - Azienda Ospedaliero-Universitaria Sant'Andrea
ACTIVE_NOT_RECRUITING
Roma
Clinica Psichiatrica, Azienda Sanitaria Universitaria Integrata di Udine
RECRUITING
Udine
Contact Information
Primary
Nicola Giordan, Dr
ngiordan@fidiapharma.it
0039 049 8232512
Time Frame
Start Date: 2019-04-18
Estimated Completion Date: 2025-12
Participants
Target number of participants: 150
Treatments
Experimental: Group A Liposom Forte + Citalopram
Liposom Forte (2 ampoules of 28mg/2 ml) for 30 days + citalopram (10mg) for 90 days
Experimental: Group B Placebo + Citalopram
Placebo (2 ampoules of 2 ml) for 30 days + citalopram (10mg) for 90 days
Related Therapeutic Areas
Sponsors
Leads: Fidia Farmaceutici s.p.a.