Major Depressive Disorder (MDD) in elderly patients MedDRA version: 21.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: LIPOSOM FORTE - 28 MG/2 ML SOLUZIONE INIETTABILE
Product Name: Liposom Forte
Product Code: [QQ05]
Pharmaceutical Form: Solution for injection
Current Sponsor code: Fosfolipidi ipotalamici
Sponsors
FIDIA FARMACEUTICI S.P.A.
Eligibility
Sex/Gender
All
Inclusion criteria
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 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1. Any contraindication for treatment or intolerance to Liposom Forte or citalopram 2. Congenital long QT syndrome, severe 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 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 6. Major neurocognitive disorders (also called dementia) 7. Diabetes Mellitus type I and II 8. Acute suicidal or violent behaviour or history of suicide attempt within the year prior to study entry or current suicidal ideation 9. Treated with long acting injectable (LAI) antipsychotics within 6 months prior to study entry 10. 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 11. Ongoing psychotherapy or other psychological treatment during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if Liposom Forte will enhance the response to antidepressant therapy with citalopram in elderly patients suffering from Major Depressive Disorder (MDD).;Secondary Objective: To determine if Liposom Forte will speed up response to antidepressant therapy with citalopram To determine the Clinical Global Impression to treatments To assess the safety of study treatments;Primary end point(s): Il miglioramento dei sintomi depressivi verrà valutato alla Visita 5 (giorno 30), attraverso la variazione rispetto al basale della Hamilton Rating Scale for Depression (HAM-D a 21-item);Timepoint(s) of evaluation of this end point: At Visit 5 (day 30) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Improvement of depressive symptoms will be evaluated over the entire study as change from baseline using the HAM-D.; Percentage of patient’s responders at V2, V3, V4 and V5. A patient with a = 50% improvement in HAM-D score vs. baseline will be considered as a responder.; Reduction of latency time will be evaluated at V2, V3, V4 and V5 using the HAM-D. Latency time will be defined as the time from baseline to response (a = 50% improvement in HAM-D score vs. baseline).; Improvement of depressive symptoms will be evaluated as change from baseline using the Geriatric Depression Scale (GDS-15) at each visit, up to V8 (Day 90).; Clinical Global Impression will be evaluated as change from baseline using the CGI score at each visit, up to V8 (Day 90).; To assess the safety of study treatments by tracking the adverse events at each visit, up to V8 (Day 90), by ECG and vital signs measurements.;Timepoint(s) of evaluation of this end point: At day 7 (V2), 14 (V3), 21 (V4), 30 (V5), 45 (V6), 60 (V7) and 90 (V8); At day 7 (V2), 14 (V3), 21 (V4), 30 (V5); At day 7 (V2), 14 (V3), 21 (V4), 30 (V5); At day 7 (V2), 14 (V3), 21 (V4), 30 (V5), 45 (V6), 60 (V7) and 90 (V8); At day 7 (V2), 14 (V3), 21 (V4), 30 (V5), 45 (V6), 60 (V7) and 90 (V8); At day 7 (V2), 14 (V3), 21 (V4), 30 (V5), 45 (V6), 60 (V7) and 90 (V8) | — |
Countries
Italy
Contacts
Public ContactScientific Direction
LB Research s.r.l.
Outcome results
None listed