Back to resultsSafety of Liposom With Citalopram in Elderly Patients With Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Recruiting
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Liposom Forte
Citalopram
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- UOC Geriatria e Lungodegenza Geriatrica PO San Filippo e Nicola di Avezzano - ASL1 Avezzano Sulmona L'aquila
- UO Psichiatria - ASST Papa Giovanni XXIII
- Unità Operativa di Psichiatria, Azienda Ospedaliero-Universitaria Mater Domini
- Ambulatorio Psichiatrico, UOC Psichiatria Presidio Ospedaliero di Codogno - ASST Lodi
- SOD Geriatria-UTIG Azienda Ospedaliero-Universitaria Careggi
- Servizio Psichiatrico di Diagnosi e Cura (SPDC) Foggia, Ospedali Riuniti di Foggia
- Servizio Psichiatrico di Diagnosi e Cura (SPDC) - ASL3 Ente Ospedaliero Ospedali Galliera
- Ambulatorio Clinica Psichiatrica, Ospedale Policlinico S. Martino
- UOC Geriatria PO San Salvatore - ASL1 Avezzano Sulmona L'Aquila
- SPDC Ospedale Fatebenefratell, UOC Psichiatria 1 ASST Fatebenefratelli SaccoRecruiting
- Centro Depressione Anziani S.C. Psichiatria 51, ASST Santi Paolo e Carlo - Presidio San PaoloRecruiting
- UO Medicina a indirizzo geriatrico ASST degli Spedali Civili di Brescia - Ospedale di Montichiari
- U.O. Psichiatria 2 Universitaria AOU Pisana - P.O. Santa Chiara
- UOC Psichiatria - Azienda Ospedaliero-Universitaria Sant'Andrea
- Centro Salute Mentale - UO Psichiatria Ambito Territoriale Est Ospedale San Lorenzo Borgo Valsugana - Azienda Provinciale per i Servizi Sanitari di Trento
- Clinica Psichiatrica, Azienda Sanitaria Universitaria Integrata di UdineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group A Liposom Forte
Group B Placebo
Arm Description
Liposom Forte (2 ampoules of 28mg/2 ml) for 30 days + citalopram (10mg) for 90 days
Placebo (2 ampoules of 2 ml) for 30 days + citalopram (10mg) for 90 days
Outcomes
Primary Outcome Measures
Change of depressive symptoms atV5(day30)as change from baseline withHamiltonRatingScaleforDepression(HAM-D).HAM-D has21items,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).
Secondary Outcome Measures
Change of latency of antidepressant therapy with citalopram. It will be evaluated at V2,V3,V4 andV5 using HAM-D.Latency time:the time from baseline to response (a≥50% improvement in HAM-D score vs baseline)
Determine if Liposom Forte will speed up response to antidepressant therapy with citalopram
ClinicalGlobalImpression as change from baseline withCGI 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
Determine the Clinical Global Impression to treatments
Safety of study treatments by tracking number and type of adverse events at each visit, up to V8 (Day 90)
To assess the safety of study treatments
Safety of study treatments by tracking, up to V8 (Day 90), 12-lead ECG, QTcF interval (Fridericia equation) will be measured
To assess the safety of study treatments
Safety of study treatments by tracking, up to V8 (Day 90), blood pressure measurements in mmHg
To assess the safety of study treatments tracking blood pressure measurement in mmHg
Safety of study treatments by tracking, up to V8 (Day 90), heart rate measurements in bpm
To assess the safety of study treatments tracking heart rate
Safety of study treatments by tracking, up to V8 (Day 90), oxygen saturation measurements in percentage with a pulse oximetry device
To assess the safety of study treatments tracking oxygen saturation
Change of depressive symptoms during the entire study as change from baseline therapy with citalopram over the entire study
Change of depressive symptoms will be evaluated over the entire study as change from baseline using the HAM-D (Hamilton Rating Scale for Depression). The score is based on the first 17 items: nine items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Eight are scored from 0-2. The score is summed and patients are categorized as follows: 0-7 = No depression 8-15 = Minor Depression
≥ 16 = Major Depression
Percentage of patients responders at V2, V3, V4 and V5. ≥50% improvement in HAM-D score vs baseline will be considered as responder.
determine if Liposom Forte will speed up response to antidepressant therapy with citalopram
Change of depressive symptoms as change from baseline using GeriatricDepressionScale(GDS-15) at each visit, up to V8(Day90). GDS:brief questionnaire:15questions with options yes or no in reference to how patients felt on the day of administration
Change of depressive symptoms will be evaluated over the entire study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04975724
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 18, 2019 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fidia Farmaceutici s.p.a.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A Liposom Forte
Arm Type
Experimental
Arm Description
Liposom Forte (2 ampoules of 28mg/2 ml) for 30 days + citalopram (10mg) for 90 days
Arm Title
Group B Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (2 ampoules of 2 ml) for 30 days + citalopram (10mg) for 90 days
Intervention Type
Drug
Intervention Name(s)
Liposom Forte
Other Intervention Name(s)
Liposom
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Citalopram
Intervention Description
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
Primary Outcome Measure Information:
Title
Change of depressive symptoms atV5(day30)as change from baseline withHamiltonRatingScaleforDepression(HAM-D).HAM-D has21items,scoring based on the first17.9items from0=not present;to4=severe.8 from0-2.Scores from the first17items summed:≥16=MajorDep
Description
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).
Time Frame
Day 30 (V5)
Secondary Outcome Measure Information:
Title
Change of latency of antidepressant therapy with citalopram. It will be evaluated at V2,V3,V4 andV5 using HAM-D.Latency time:the time from baseline to response (a≥50% improvement in HAM-D score vs baseline)
Description
Determine if Liposom Forte will speed up response to antidepressant therapy with citalopram
Time Frame
From baseline through 30 days follow-up (V5)
Title
ClinicalGlobalImpression as change from baseline withCGI 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
Description
Determine the Clinical Global Impression to treatments
Time Frame
From baseline through 90 days follow-up (V8)
Title
Safety of study treatments by tracking number and type of adverse events at each visit, up to V8 (Day 90)
Description
To assess the safety of study treatments
Time Frame
From baseline through 90 days follow-up (V8)
Title
Safety of study treatments by tracking, up to V8 (Day 90), 12-lead ECG, QTcF interval (Fridericia equation) will be measured
Description
To assess the safety of study treatments
Time Frame
From baseline to Day 14 (V3) and Day 90 (V8)
Title
Safety of study treatments by tracking, up to V8 (Day 90), blood pressure measurements in mmHg
Description
To assess the safety of study treatments tracking blood pressure measurement in mmHg
Time Frame
From baseline through 90 days follow-up (V8)
Title
Safety of study treatments by tracking, up to V8 (Day 90), heart rate measurements in bpm
Description
To assess the safety of study treatments tracking heart rate
Time Frame
From baseline through 90 days follow-up (V8)
Title
Safety of study treatments by tracking, up to V8 (Day 90), oxygen saturation measurements in percentage with a pulse oximetry device
Description
To assess the safety of study treatments tracking oxygen saturation
Time Frame
From baseline through 90 days follow-up (V8)
Title
Change of depressive symptoms during the entire study as change from baseline therapy with citalopram over the entire study
Description
Change of depressive symptoms will be evaluated over the entire study as change from baseline using the HAM-D (Hamilton Rating Scale for Depression). The score is based on the first 17 items: nine items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Eight are scored from 0-2. The score is summed and patients are categorized as follows: 0-7 = No depression 8-15 = Minor Depression
≥ 16 = Major Depression
Time Frame
From baseline through 90 days follow-up (V8)
Title
Percentage of patients responders at V2, V3, V4 and V5. ≥50% improvement in HAM-D score vs baseline will be considered as responder.
Description
determine if Liposom Forte will speed up response to antidepressant therapy with citalopram
Time Frame
From baseline through 30 days follow-up (V5)
Title
Change of depressive symptoms as change from baseline using GeriatricDepressionScale(GDS-15) at each visit, up to V8(Day90). GDS:brief questionnaire:15questions with options yes or no in reference to how patients felt on the day of administration
Description
Change of depressive symptoms will be evaluated over the entire study
Time Frame
From baseline through 90 days follow-up (V8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola Giordan, Dr
Phone
0039 049 8232512
Email
ngiordan@fidiapharma.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Giordan
Organizational Affiliation
Fidia Farmaceutici s.p.a.
Official's Role
Study Director
Facility Information:
Facility Name
UOC Geriatria e Lungodegenza Geriatrica PO San Filippo e Nicola di Avezzano - ASL1 Avezzano Sulmona L'aquila
City
Avezzano
ZIP/Postal Code
67051
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
UO Psichiatria - ASST Papa Giovanni XXIII
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Unità Operativa di Psichiatria, Azienda Ospedaliero-Universitaria Mater Domini
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ambulatorio Psichiatrico, UOC Psichiatria Presidio Ospedaliero di Codogno - ASST Lodi
City
Codogno
ZIP/Postal Code
26845
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
SOD Geriatria-UTIG Azienda Ospedaliero-Universitaria Careggi
City
Firenze
ZIP/Postal Code
50100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Servizio Psichiatrico di Diagnosi e Cura (SPDC) Foggia, Ospedali Riuniti di Foggia
City
Foggia
ZIP/Postal Code
71122
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Servizio Psichiatrico di Diagnosi e Cura (SPDC) - ASL3 Ente Ospedaliero Ospedali Galliera
City
Genova
ZIP/Postal Code
16128
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ambulatorio Clinica Psichiatrica, Ospedale Policlinico S. Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
UOC Geriatria PO San Salvatore - ASL1 Avezzano Sulmona L'Aquila
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
SPDC Ospedale Fatebenefratell, UOC Psichiatria 1 ASST Fatebenefratelli Sacco
City
Milano
ZIP/Postal Code
20121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudio Mencacci
Facility Name
Centro Depressione Anziani S.C. Psichiatria 51, ASST Santi Paolo e Carlo - Presidio San Paolo
City
Milano
ZIP/Postal Code
20142
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simone Cavallotti
Facility Name
UO Medicina a indirizzo geriatrico ASST degli Spedali Civili di Brescia - Ospedale di Montichiari
City
Montichiari
ZIP/Postal Code
25018
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
U.O. Psichiatria 2 Universitaria AOU Pisana - P.O. Santa Chiara
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
UOC Psichiatria - Azienda Ospedaliero-Universitaria Sant'Andrea
City
Roma
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Centro Salute Mentale - UO Psichiatria Ambito Territoriale Est Ospedale San Lorenzo Borgo Valsugana - Azienda Provinciale per i Servizi Sanitari di Trento
City
Trento
ZIP/Postal Code
38151
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Clinica Psichiatrica, Azienda Sanitaria Universitaria Integrata di Udine
City
Udine
ZIP/Postal Code
33100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Balestrieri
12. IPD Sharing Statement
Learn more about this trial
Safety of Liposom With Citalopram in Elderly Patients With Major Depressive Disorder
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