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

Major Depressive Disorder Clinical Trial

Official title: 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)

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

The effects of phospholipid liposomes when associated with antidepressant drugs are very interesting. In addition to an improvement of somatic symptoms of depression, measured with the Hamilton Rate Scale for Depression, liposomes are able to reduce the latency of onset of the antidepressant activity of drugs like amitriptyline, clomipramine, and trazodone. These results indicate that phospholipids can be used as an adjuvant to antidepressant therapy, also allowing specific antidepressant drug dose reduction. Thus, the hypothesis is that combination therapy would not only lead to greater efficacy, but also to a more rapid onset of therapeutic response. The addition of Liposom Forte may be clinically important since it may ensure the use of lower citalopram doses, thereby reducing the risk of adverse events, and this may prove to be important, especially in elderly people. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT04975724
• Study type: Interventional
• Source: Fidia Farmaceutici s.p.a.
• Contact: Nicola Giordan, Dr
• Phone: 0039 049 8232512
• Email: ngiordan@fidiapharma.it
• Status: Recruiting
• Phase: Phase 4
• Start date: April 18, 2019
• Completion date: December 2025