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)

QQ05.16.02

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).

2019-04-18

2025-10-01

2025-12-01

Recruiting

Early phase I

150

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}

2024-01-17