HYPOTHALAMIC PHOSPHOLIPIDS for Major depressive disorder

Inclusion criteria

• {"criterion_text":"- Meets DSM-V criteria for major depressive disorder\n- Score of ≥ 16 in the HAM-D\n- Score of ≥ 23 on the Mini-Mental State Exam (MMSE-2)\n- Aged ≥ 65 years\n- Patients able to understand the study procedures and to comply with protocol requirements\n- Patients legally able to give written informed consent to the trial (signed and dated by the subject)"}

Exclusion criteria

• {"criterion_text":"- Any contraindication for treatment or intolerance to Liposom Forte or citalopram\n- 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\n- Ongoing psychotherapy or other psychological treatment during the study period\n- Congenital long QT syndrome, severe bradycardia, recent acute myocardial infarction, uncompensated heart failure or concomitant use of drugs that prolong the QT interval\n- History of psychiatric disorder other than major depressive disorder, including history of substance use disorder\n- Presence of psychotic symptoms, even if they are not sufficient to make diagnosis of a mental disorder\n- 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\n- Major neurocognitive disorders (also called dementia)\n- Diabetes Mellitus type I and II\n- Acute suicidal or violent behaviour or history of suicide attempt within the year prior to study entry or current suicidal ideation\n- Treated with long acting injectable (LAI) antipsychotics within 6 months prior to study entry"}

Primary endpoints

• {"endpoint_text":"- Improvement of depressive symptoms will be evaluated at Visit 5 (day 30), as change from baseline, using the Hamilton Rating Scale for Depression (21-item HAM-D).","definition_or_measurement_approach":"Change from baseline at Visit 5 (Day 30) measured using the 21-item Hamilton Rating Scale for Depression (HAM-D)."}

Secondary endpoints

• {"endpoint_text":"- Improvement of depressive symptoms will be evaluated over the entire study as change from baseline using the HAM-D.","definition_or_measurement_approach":"Change from baseline over entire study measured by HAM-D score."}
• {"endpoint_text":"- Percentage of patients 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.","definition_or_measurement_approach":"Responder defined as ≥ 50% improvement in HAM-D vs baseline; percentage responders assessed at Visits V2, V3, V4, V5."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Latency time = time from baseline to response (≥ 50% improvement in HAM-D); assessed at V2, V3, V4, V5 using HAM-D."}
• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Change from baseline at each visit up to Day 90 measured by GDS-15."}
• {"endpoint_text":"- Clinical Global Impression will be evaluated as change from baseline using the CGI score at each visit, up to V8 (Day 90).","definition_or_measurement_approach":"Change from baseline at each visit up to Day 90 measured by CGI score."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Safety assessed via adverse event reporting at each visit, ECGs and vital signs up to Day 90."}

Italy

Earliest CTIS Part Ii Submission Date

23-09-2024

Latest Decision Or Authorization Date

23-12-2025

Processing Time Days

456

Number Of Sites

3

Number Of Participants

150

Primary sponsor

Full Name

Fidia Farmaceutici S.p.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Nerpharma S.r.l.","duties_or_roles":"sponsorDuties codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Lb Research S.r.l.","duties_or_roles":"sponsorDuties codes: 1,10,11,5,6,7","organisation_type":"Pharmaceutical company"}