A randomized, double-blind, placebo-controlled, multicenter clinical trial to assess safety and effectiveness of Liposom in enhance and speed up response to antidepressant therapy with citalopram in elderly patients suffering from Major Depressive Disorder (MDD)

Korábbi kezelés

• Treated with any antipsychotics, antidepressant, food supplements (St. John's Wort) or over-the-counter CNS-active medications within 2 weeks prior to the first administration of study medication, with the exception of MAOIs, for which the treatment is not permitted in the 3 weeks prior to the first administration of study medication
• 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

Más betegség

• 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 uncompensated and/or acute organic disease or any other medical condition which may interfere with the aim of the study or with the subject health and well-being
• Major neurocognitive disorders (also called dementia)
• Diabetes Mellitus type I and II

Laborértékek

• Congenital long QT syndrome, severe bradycardia, recent acute myocardial infarction, uncompensated heart failure or concomitant use of drugs that prolong the QT interval

Egyéb

• Any contraindication for treatment or intolerance to Liposom Forte or citalopram
• Ongoing psychotherapy or other psychological treatment during the study period

• 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 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)