Clinical trial NCT04975724: Safety of Liposom With Citalopram in Elderly Patients With Major Depressive Disorder
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Major Depressive Disorder
Lead sponsor: Fidia Farmaceutici s.p.a.
Sponsor class: INDUSTRY
First posted: 2021-07-23
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: The effects of phospholipid liposomes when associated with antidepressant drugs are very interesting. In addition to an improvement of somatic symptoms of depression, measured with the Hamilton Rate Scale for Depression, liposomes are able to reduce the latency of onset of the antidepressant activity of drugs like amitriptyline, clomipramine, and trazodone. These results indicate that phospholipids can be used as an adjuvant to antidepressant therapy, also allowing specific antidepressant drug dose reduction. Thus, the hypothesis is that combination therapy would not only lead to greater efficacy, but also to a more rapid onset of therapeutic response. The addition of Liposom Forte may be clinically important since it may ensure the use of lower citalopram doses, thereby reducing the risk of adverse events, and this may prove to be important, especially in elderly people.

Eligibility 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 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

Primary outcomes:
measure: Change of depressive symptoms atV5(day30)as change from baseline with HamiltonRatingScaleforDepression (21items,scoring based on the first17.9items from0=not present;to4=severe.8 from0-2.Scores from the first17items summed:≥16=MajorDep)
timeFrame: Day 30 (V5)
Secondary outcomes:
measure: Change of latency of antidepressant therapy with citalopram. Evaluated at V2,V3,V4 and V5 using HamiltonRatingScaleforDepression Latency time:the time from baseline to response (a≥50% improvement in HAM-D score vs baseline)
timeFrame: From baseline through 30 days follow-up (V5)
measure: ClinicalGlobalImpression as change from baseline up toV8Day90.CGI:7point scale clinician-rated(severity of illness)from1(normal)to7(severely ill).CGI score from1(very much improved)to7(very much worse).Treatment response consider efficacy andAEs
timeFrame: From baseline through 90 days follow-up (V8)
measure: Safety of study treatments by tracking number and type of adverse events at each visit, up to V8 (Day 90)
timeFrame: From baseline through 90 days follow-up (V8)
measure: Safety of study treatments by tracking, up to V8 (Day 90), 12-lead ECG, QTcF interval (Fridericia equation) will be measured
timeFrame: From baseline to Day 14 (V3) and Day 90 (V8)
measure: Safety of study treatments by tracking, up to V8 (Day 90), blood pressure measurements in mmHg
timeFrame: From baseline through 90 days follow-up (V8)
measure: Safety of study treatments by tracking, up to V8 (Day 90), heart rate measurements in bpm
timeFrame: From baseline through 90 days follow-up (V8)
measure: Safety of study treatments by tracking, up to V8 (Day 90), oxygen saturation measurements in percentage with a pulse oximetry device
timeFrame: From baseline through 90 days follow-up (V8)
measure: Change of depressive symptoms during the entire study as change from baseline therapy with citalopram over the entire study
timeFrame: From baseline through 90 days follow-up (V8)
measure: Percentage of patients responders at V2, V3, V4 and V5. ≥50% improvement in HAM-D score vs baseline will be considered as responder.
timeFrame: From baseline through 30 days follow-up (V5)
measure: Change of depressive symptoms as change from baseline using Geriatric Depression Scale (GDS-15).
timeFrame: From baseline through 90 days follow-up (V8)
Other outcomes:
Locations:
city: Avezzano
country: Italy
facility: UOC Geriatria e Lungodegenza Geriatrica PO San Filippo e Nicola di Avezzano - ASL1 Avezzano Sulmona L'aquila
city: Bergamo
country: Italy
facility: UO Psichiatria - ASST Papa Giovanni XXIII
city: Codogno
country: Italy
facility: Ambulatorio Psichiatrico, UOC Psichiatria Presidio Ospedaliero di Codogno - ASST Lodi
city: Firenze
country: Italy
facility: SOD Geriatria-UTIG Azienda Ospedaliero-Universitaria Careggi
city: Foggia
country: Italy
facility: Servizio Psichiatrico di Diagnosi e Cura (SPDC) Foggia, Ospedali Riuniti di Foggia
city: Genova
country: Italy
facility: Servizio Psichiatrico di Diagnosi e Cura (SPDC) - ASL3 Ente Ospedaliero Ospedali Galliera
city: Genova
country: Italy
facility: Ambulatorio Clinica Psichiatrica, Ospedale Policlinico S. Martino
city: L'Aquila
country: Italy
facility: UOC Geriatria PO San Salvatore - ASL1 Avezzano Sulmona L'Aquila
city: Milano
country: Italy
facility: SPDC Ospedale Fatebenefratell, UOC Psichiatria 1 ASST Fatebenefratelli Sacco
city: Milano
country: Italy
facility: Centro Depressione Anziani S.C. Psichiatria 51, ASST Santi Paolo e Carlo - Presidio San Paolo
city: Roma
country: Italy
facility: UOC Psichiatria - Azienda Ospedaliero-Universitaria Sant'Andrea
city: Udine
country: Italy
facility: Clinica Psichiatrica, Azienda Sanitaria Universitaria Integrata di Udine
Study officials:
affiliation: Fidia Farmaceutici s.p.a.
name: Nicola Giordan
role: STUDY_DIRECTOR
References: