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)

2024-512293-10-00 Protocol QQ05.16.02 Therapeutic use (Phase IV) Ongoing, recruiting

Start 10 Dec 2018 · Status Ongoing, recruiting · 1 EU/EEA countries · 3 sites · Protocol QQ05.16.02

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 150
Countries 1
Sites 3

Major Depressive Disorder in elderly patients

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).

Key facts

Sponsor
Fidia Farmaceutici S.p.A.
Participant type
Patients
Age range
65+ years
Gender
Male and Female
Therapeutic area
Psychiatry and Psychology [F] - Psychological Phenomena [F02]
Trial duration
10 Dec 2018 → ongoing
Decision date (initial)
2024-11-12
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Fidia Farmaceutici S.p.A.

External identifiers

EU CT number
2024-512293-10-00
EudraCT number
2018-001622-26
ClinicalTrials.gov
NCT04975724

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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).

Secondary objectives 3

  1. To determine if Liposom Forte will speed up response to antidepressant therapy with citalopram
  2. To determine the Clinical Global Impression to treatments
  3. To assess the safety of study treatments.

Conditions and MedDRA coding

Major Depressive Disorder in elderly patients

VersionLevelCodeTermSystem organ class
21.1 PT 10057840 Major depression 100000004873

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Treatment period details
All subjects will receive a daily dose of 10mg of citalopram by oral route, open-label throughout the trial and they will continue for 90 days. As add-on treatment, patients will receive also 2 ampoules of Liposom Forte/Placebo, in a blinded-manner, administered as single intramuscular injection for 30 days.
 Randomised Controlled Double [{"id":121504,"code":3,"name":"Monitor"},{"id":121505,"code":2,"name":"Investigator"},{"id":121503,"code":1,"name":"Subject"},{"id":121506,"code":4,"name":"Analyst"}] Arm A: Liposom Forte (2 ampoules of 28mg/2 ml) + citalopram (10mg)
Arm B: Placebo (2 ampoules of 2 ml) + citalopram (10mg)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  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)

Exclusion criteria 11

  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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 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).

Secondary endpoints 6

  1. Improvement of depressive symptoms will be evaluated over the entire study as change from baseline using the HAM-D.
  2. 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.
  3. 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).
  4. 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).
  5. Clinical Global Impression will be evaluated as change from baseline using the CGI score at each visit, up to V8 (Day 90).
  6. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

LIPOSOM FORTE “28 mg/2 ml soluzione iniettabile”

PRD518716 · Product

Active substance
Hypothalamic Phospholipids
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAMUSCULAR USE
Max daily dose
56 mg milligram(s)
Max total dose
1680 mg milligram(s)
Max treatment duration
30 Day(s)
Authorisation status
Authorised
ATC code
N07XX — OTHER NERVOUS SYSTEM DRUGS
Marketing authorisation
021432024
MA holder
FIDIA FARMACEUTICI S.P.A
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Placebo 1

Placebo of Liposom Forte

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Auxiliary 1

Citalopram Aurobindo 20 mg compresse rivestite con film.

PRD346599 · Product

Active substance
Citalopram Hydrobromide
Pharmaceutical form
FILM-COATED TABLET
Route of administration
ORAL USE
Max daily dose
10 mg milligram(s)
Max total dose
900 mg milligram(s)
Max treatment duration
90 Day(s)
Authorisation status
Authorised
ATC code
N06AB04 — CITALOPRAM
Marketing authorisation
036675015
MA holder
AUROBINDO PHARMA (ITALIA) S.R.L.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fidia Farmaceutici S.p.A.

5 Total trials 4 Recruiting 1 Ended
Commercial
Sponsor organisation
Fidia Farmaceutici S.p.A.
Address
Via Ponte Della Fabbrica 3 A
City
Abano Terme
Postcode
35031
Country
Italy

Scientific contact point

Organisation
Fidia Farmaceutici S.p.A.
Contact name
Corporate Clinical & Preclinical Development

Public contact point

Organisation
Fidia Farmaceutici S.p.A.
Contact name
Corporate Clinical & Preclinical Development

Third parties 2

OrganisationCity, countryDuties
Nerpharma S.r.l.
ORG-100012283
 Nerviano, Italy Code 14
Lb Research S.r.l.
ORG-100010325
 Cantu', Italy On site monitoring, Code 10, Code 11, Code 5, Data management, E-data capture

Locations

1 EU/EEA country · 3 investigational sites

By country

CountryMS statusPlanned subjectsSites
Italy Ongoing, recruiting 150 3
Rest of world — 0 —

Investigational sites

Italy

3 sites · Ongoing, recruiting
Azienda Ospedaliero-Universitaria Sant Andre
U.O.C. Psichiatria, Via Di Grottarossa 1035-1039, 00189, Rome
ASST Fatebenefratelli Sacco
SPDC (Servizio Psichiatrico Diagnosi e Cura), Piazzale Principessa Clotilde 3, 20121, Milan
PO San Filippo e Nicola di Avezzano - ASL1 Avezzano Sulmona L'Aquila
UOC Geriatria e Lungodegenza Geriatrica, Via G. Di Vittorio, 6, Avezzano

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Italy 2018-12-10 2019-04-18

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol SSU contact update_2024-512293-10-00_for publication NA
Protocol (for publication) D1_Protocol_2024-512293-10-00_for publication 6
Recruitment arrangements (for publication) 2024-512293-10-00_Placeholder_document_CTIS NA
Subject information and informed consent form (for publication) L1_SIS and ICF study 2
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Liposom Forte NA
Synopsis of the protocol (for publication) D1_Protocol synopsis_IT_2024-512293-10-00 6

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-10 Italy Acceptable
2024-11-05
 2024-11-12
2 SUBSTANTIAL MODIFICATION SM-1 2025-10-29 Italy Acceptable 2025-12-23

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