Safety of Liposom With Citalopram in Elderly Patients With Major Depressive Disorder

NCT04975724 | Unknown Phase 4

• 1 other identifier: QQ05.16.02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 12

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).

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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)

  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). HamiltonRatingScaleforDepression (21items,scoring based on the first17.9items from0=not present;to4=severe.8 from0-2.Scores from the first17items summed:≥16=MajorDep)

  Day 30 (V5)

Secondary Outcomes (10)

• 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)

  From baseline through 30 days follow-up (V5)

• 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

  From baseline through 90 days follow-up (V8)

• Safety of study treatments by tracking number and type of adverse events at each visit, up to V8 (Day 90)

  From baseline through 90 days follow-up (V8)

• Safety of study treatments by tracking, up to V8 (Day 90), 12-lead ECG, QTcF interval (Fridericia equation) will be measured

  From baseline to Day 14 (V3) and Day 90 (V8)

• Safety of study treatments by tracking, up to V8 (Day 90), blood pressure measurements in mmHg

  From baseline through 90 days follow-up (V8)

Study Arms (2)

Group A Liposom Forte + Citalopram

EXPERIMENTAL

Liposom Forte (2 ampoules of 28mg/2 ml) for 30 days + citalopram (10mg) for 90 days

Drug: Liposom Forte; Drug: Citalopram

Group B Placebo + Citalopram

EXPERIMENTAL

Placebo (2 ampoules of 2 ml) for 30 days + citalopram (10mg) for 90 days

Drug: Citalopram; Other: Placebo

Interventions

Liposom Forte DRUG

Liposom Forte 28mg/2ml solution for injection contains a mixture of purified hypothalamic phospholipids (PLs) from swine brains. The key components of the phospholipid mixture are phosphatidylcholine (PC), phosphatidylethanolamine (PE) and phosphatidylserine (PS).

Also known as: Liposom

Group A Liposom Forte + Citalopram

Citalopram DRUG

The medicinal product Citalopram Aurobindo contains citalopram as active ingredient available on the market in 20 mg film coated tablets. The tablets are divisible in two equal part of 10 mg as reported in the SmPC

Group A Liposom Forte + Citalopram; Group B Placebo + Citalopram

Placebo OTHER

Liposom Forte Placebo (2 ampoules of 2 ml solution for injection)

Also known as: Placebo of Liposom Forte

Group B Placebo + Citalopram

Eligibility Criteria

• Age: 65 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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 and \< 85 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)

You may not qualify if:

• Any contraindication for treatment or intolerance to Liposom Forte or citalopram
• Congenital long QT syndrome, bradycardia, recent acute myocardial infarction, uncompensated heart failure or concomitant use of drugs that prolong the QT interval
• 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 organic disease (e.g., major surgery, metastatic cancer, stroke, delirium, severe neurological disorder, heart attack, chronic heart failure, asthma, severe cardio circulatory disorders)
• Diabetes Mellitus type I and II
• 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
• 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
• Ongoing or planned psychotherapy or other psychological treatment during the study period

Sponsors & Collaborators

• Fidia Farmaceutici s.p.a.: lead

Study Sites (12)

UOC Geriatria e Lungodegenza Geriatrica PO San Filippo e Nicola di Avezzano - ASL1 Avezzano Sulmona L'aquila

Avezzano, 67051, Italy

RECRUITING

UO Psichiatria - ASST Papa Giovanni XXIII

Bergamo, 24127, Italy

ACTIVE NOT RECRUITING

Ambulatorio Psichiatrico, UOC Psichiatria Presidio Ospedaliero di Codogno - ASST Lodi

Codogno, 26845, Italy

ACTIVE NOT RECRUITING

SOD Geriatria-UTIG Azienda Ospedaliero-Universitaria Careggi

Florence, 50100, Italy

ACTIVE NOT RECRUITING

Servizio Psichiatrico di Diagnosi e Cura (SPDC) Foggia, Ospedali Riuniti di Foggia

Foggia, 71122, Italy

ACTIVE NOT RECRUITING

Servizio Psichiatrico di Diagnosi e Cura (SPDC) - ASL3 Ente Ospedaliero Ospedali Galliera

Genova, 16128, Italy

ACTIVE NOT RECRUITING

Ambulatorio Clinica Psichiatrica, Ospedale Policlinico S. Martino

Genova, 16132, Italy

ACTIVE NOT RECRUITING

UOC Geriatria PO San Salvatore - ASL1 Avezzano Sulmona L'Aquila

L’Aquila, 67100, Italy

ACTIVE NOT RECRUITING

SPDC Ospedale Fatebenefratell, UOC Psichiatria 1 ASST Fatebenefratelli Sacco

Milan, 20121, Italy

RECRUITING

Centro Depressione Anziani S.C. Psichiatria 51, ASST Santi Paolo e Carlo - Presidio San Paolo

Milan, 20142, Italy

RECRUITING

UOC Psichiatria - Azienda Ospedaliero-Universitaria Sant'Andrea

Roma, 00189, Italy

ACTIVE NOT RECRUITING

Clinica Psichiatrica, Azienda Sanitaria Universitaria Integrata di Udine

Udine, 33100, Italy

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

liposom; Citalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nicola Giordan

  Fidia Farmaceutici s.p.a.

  STUDY DIRECTOR

Central Study Contacts

Nicola Giordan, Dr

CONTACT

0039 049 8232512; ngiordan@fidiapharma.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: July 23, 2021
• Study Start: April 18, 2019
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

IT (12)