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

  • STATUS
    Recruiting
  • End date
    Dec 2, 2023
  • participants needed
    150
  • sponsor
    Fidia Farmaceutici s.p.a.
Updated on 2 August 2021

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).

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.

Details
Condition Major depression, Endogenous depression, major depressive disorder, major depressive disorders
Treatment citalopram, Liposom Forte
Clinical Study IdentifierNCT04975724
SponsorFidia Farmaceutici s.p.a.
Last Modified on2 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

Any contraindication for treatment or intolerance to Liposom Forte or citalopram
Congenital long QT syndrome, bradycardia, recent acute myocardial infarction, uncompensated heart failure or concomitant use of drugs that prolong the QT interval
History of psychiatric disorder other than major depressive disorder, including history of substance use disorder
Presence of psychotic symptoms, even if they are not sufficient to make diagnosis of a mental disorder
Severe organic disease (e.g., major surgery, metastatic cancer, stroke, delirium, severe neurological disorder, heart attack, chronic heart failure, asthma, severe cardio circulatory disorders)
Diabetes Mellitus type I and II
Acute suicidal or violent behaviour or history of suicide attempt within the year prior to study entry or current suicidal ideation
Treated with long acting injectable (LAI) antipsychotics within 6 months prior to study entry
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
Ongoing or planned psychotherapy or other psychological treatment during the study period
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