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

Fidia Farmaceutici s.p.a.150 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Major Depressive Disorder

Interventions

Liposom ForteDRUG

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).

CitalopramDRUG

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

PlaceboOTHER

Liposom Forte Placebo (2 ampoules of 2 ml solution for injection)

Eligibility

Sex: ALLMin age: 65 YearsMax age: 84 Years

Medical Language ↔ Plain English

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

Locations (12)

UOC Geriatria e Lungodegenza Geriatrica PO San Filippo e Nicola di Avezzano - ASL1 Avezzano Sulmona L'aquila

Avezzano, Italy

RECRUITING

UO Psichiatria - ASST Papa Giovanni XXIII

Outcomes

Primary Outcomes

Change of depressive symptoms atV5(day30)as change from baseline with HamiltonRatingScaleforDepression (21items,scoring based on the first17.9items from0=not present;to4=severe.8 from0-2.Scores from the first17items summed:≥16=MajorDep)

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). HamiltonRatingScaleforDepression (21items,scoring based on the first17.9items from0=not present;to4=severe.8 from0-2.Scores from the first17items summed:≥16=MajorDep)

Time frame: Day 30 (V5)

Secondary Outcomes

Change of latency of antidepressant therapy with citalopram. Evaluated at V2,V3,V4 and V5 using HamiltonRatingScaleforDepression Latency time:the time from baseline to response (a≥50% improvement in HAM-D score vs baseline)

Determine if Liposom Forte will speed up response to antidepressant therapy with citalopram HamiltonRatingScaleforDepression (21items,scoring based on the first17.9items from0=not present;to4=severe.8 from0-2.Scores from the first17items summed:≥16=MajorDep)

Time frame: From baseline through 30 days follow-up (V5)

ClinicalGlobalImpression as change from baseline up toV8Day90.CGI:7point scale clinician-rated(severity of illness)from1(normal)to7(severely ill).CGI score from1(very much improved)to7(very much worse).Treatment response consider efficacy andAEs

Determine the Clinical Global Impression to treatments

Time frame: From baseline through 90 days follow-up (V8)

Safety of study treatments by tracking number and type of adverse events at each visit, up to V8 (Day 90)

To assess the safety of study treatments

Time frame: From baseline through 90 days follow-up (V8)

Safety of study treatments by tracking, up to V8 (Day 90), 12-lead ECG, QTcF interval (Fridericia equation) will be measured

Central Contacts

Nicola Giordan, Dr

CONTACT

0039 049 8232512 ngiordan@fidiapharma.it

Data from ClinicalTrials.gov

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