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

NCT04975724 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-01-17

No results posted yet for this study

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).

Conditions

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)

Sponsors & Collaborators

  • Fidia Farmaceutici s.p.a.

    lead INDUSTRY

Principal Investigators

  • Nicola Giordan · Fidia Farmaceutici s.p.a.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-18
Primary Completion
2025-10-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04975724 on ClinicalTrials.gov