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

Fidia Pharma

Status and phase: Enrolling; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Liposom Forte; Drug: Citalopram; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04975724

QQ05.16.02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 65 to 84 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Meets DSM-V criteria for major depressive disorder
2. Score of ≥ 16 in the HAM-D
3. Score of ≥ 23 on the Mini-Mental State Exam (MMSE-2)
4. Aged ≥ 65 and < 85 years
5. Patients able to understand the study procedures and to comply with protocol requirements
6. Patients legally able to give written informed consent to the trial (signed and dated by the subject)

Exclusion criteria

1. Any contraindication for treatment or intolerance to Liposom Forte or citalopram
2. Congenital long QT syndrome, bradycardia, recent acute myocardial infarction, uncompensated heart failure or concomitant use of drugs that prolong the QT interval
3. History of psychiatric disorder other than major depressive disorder, including history of substance use disorder
4. Presence of psychotic symptoms, even if they are not sufficient to make diagnosis of a mental disorder
5. Severe organic disease (e.g., major surgery, metastatic cancer, stroke, delirium, severe neurological disorder, heart attack, chronic heart failure, asthma, severe cardio circulatory disorders)
6. Diabetes Mellitus type I and II
7. Acute suicidal or violent behaviour or history of suicide attempt within the year prior to study entry or current suicidal ideation
8. Treated with long acting injectable (LAI) antipsychotics within 6 months prior to study entry
9. 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
10. Ongoing or planned psychotherapy or other psychological treatment during the study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups

Group A Liposom Forte + Citalopram

Experimental group

Description:

Liposom Forte (2 ampoules of 28mg/2 ml) for 30 days + citalopram (10mg) for 90 days

Treatment:

Drug: Citalopram

Drug: Liposom Forte

Group B Placebo + Citalopram

Experimental group

Description:

Placebo (2 ampoules of 2 ml) for 30 days + citalopram (10mg) for 90 days

Treatment:

Other: Placebo

Drug: Citalopram