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

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 protocolrequirements
6. Patients legally able to give written informed consent to the trial (signed and datedby 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, includinghistory of substance use disorder
4. Presence of psychotic symptoms, even if they are not sufficient to make diagnosis of amental disorder
5. Severe organic disease (e.g., major surgery, metastatic cancer, stroke, delirium,severe neurological disorder, heart attack, chronic heart failure, asthma, severecardio circulatory disorders)
6. Diabetes Mellitus type I and II
7. Acute suicidal or violent behaviour or history of suicide attempt within the yearprior to study entry or current suicidal ideation
8. Treated with long acting injectable (LAI) antipsychotics within 6 months prior tostudy entry
9. Treated with any antipsychotics, antidepressant, food supplements or over-the-counterCNS-active medications (e.g, St. John's Wort, melatonin, Selective Serotonin ReuptakeInhibitors [SSRIs], Serotonin and norepinephrine reuptake inhibitors [SNRIs],Monoamine-Oxidase Inhibitors [MAOIs], or other antidepressants) within 4 weeks priorto the first administration of study medication
10. Ongoing or planned psychotherapy or other psychological treatment during the studyperiod