Major Depressive DisorderPhase 4NCT04975724
Safety of Liposom With Citalopram in Elderly Patients With Major Depressive Disorder
A Phase 4 study testing Liposom Forte and Citalopram in people with Major Depressive Disorder, run by Fidia Farmaceutici s.p.a. at 12 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 to 84 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Liposom Forte and Citalopram
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 12 sitesItaly
- Study dates
- 18 Apr 2019to Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 84 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Italy12 sites, 4 recruiting
- Recruiting
UOC Geriatria e Lungodegenza Geriatrica PO San Filippo e Nicola di Avezzano - ASL1 Avezzano Sulmona L'aquila
Avezzano, 67051
Giovambattista Desideri
- Active, not recruiting
UO Psichiatria - ASST Papa Giovanni XXIII
Bergamo, 24127
- Active, not recruiting
Ambulatorio Psichiatrico, UOC Psichiatria Presidio Ospedaliero di Codogno - ASST Lodi
Codogno, 26845
- Active, not recruiting
SOD Geriatria-UTIG Azienda Ospedaliero-Universitaria Careggi
Florence, 50100
- Active, not recruiting
Servizio Psichiatrico di Diagnosi e Cura (SPDC) Foggia, Ospedali Riuniti di Foggia
Foggia, 71122
- Active, not recruiting
Servizio Psichiatrico di Diagnosi e Cura (SPDC) - ASL3 Ente Ospedaliero Ospedali Galliera
Genova, 16128
- Active, not recruiting
Ambulatorio Clinica Psichiatrica, Ospedale Policlinico S. Martino
Genova, 16132
- Active, not recruiting
UOC Geriatria PO San Salvatore - ASL1 Avezzano Sulmona L'Aquila
L’Aquila, 67100
- Recruiting
SPDC Ospedale Fatebenefratell, UOC Psichiatria 1 ASST Fatebenefratelli Sacco
Milan, 20121
Bernardo Dell'Osso
- Recruiting
Centro Depressione Anziani S.C. Psichiatria 51, ASST Santi Paolo e Carlo - Presidio San Paolo
Milan, 20142
Simone Cavallotti
- Active, not recruiting
UOC Psichiatria - Azienda Ospedaliero-Universitaria Sant'Andrea
Roma, 00189
- Recruiting
Clinica Psichiatrica, Azienda Sanitaria Universitaria Integrata di Udine
Udine, 33100
Matteo Balestrieri
About this study
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)
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).
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Liposom Forte, Citalopram, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposom ForteDrug
Also called Liposom
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).
CitalopramDrug
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
PlaceboOther
Also called Placebo of Liposom Forte
Liposom Forte Placebo (2 ampoules of 2 ml solution for injection)
| Study group | Role | What they receive |
|---|---|---|
| Group A Liposom Forte + Citalopram | Experimental | Liposom Forte (2 ampoules of 28mg/2 ml) for 30 days + citalopram (10mg) for 90 days Receives: Drug: Liposom Forte; Drug: Citalopram |
| Group B Placebo + Citalopram | Experimental | Placebo (2 ampoules of 2 ml) for 30 days + citalopram (10mg) for 90 days Receives: Drug: Citalopram; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Determine if Liposom Forte will speed up response to antidepressant therapy with citalopram HamiltonRatingScaleforDepression (21items,scoring based on the first17.9items from0=not present;to4=severe.8 from0-2.Scores from the first17items summed:≥16=MajorDep)
Measured: 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
Determine the Clinical Global Impression to treatments
Measured: 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)
To assess the safety of study treatments
Measured: 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
To assess the safety of study treatments
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
To assess the safety of study treatments tracking blood pressure measurement in mmHg
Measured: From baseline through 90 days follow-up (V8)
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
Measured: From baseline through 90 days follow-up (V8)
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
Measured: From baseline through 90 days follow-up (V8)
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
Measured: From baseline through 90 days follow-up (V8)
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
Measured: From baseline through 30 days follow-up (V5)
Change of depressive symptoms as change from baseline using Geriatric Depression Scale (GDS-15).
Change of depressive symptoms will be evaluated over the entire study. GDS:brief questionnaire:15questions with options yes or no in reference to how patients felt on the day of administration. Answers indicating depression are in bold and italicized; score one point for each one selected. A score of 0 to 5 is normal. A score greater than 5 suggests depression.
Measured: From baseline through 90 days follow-up (V8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start18 Apr 2019
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fidia Farmaceutici s.p.a.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicola Giordan, Study director, Fidia Farmaceutici s.p.a.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975724
- Sponsor's protocol ID
- QQ05.16.02
- Status last verified
- Jan 2024
- First submitted
- 2 Mar 2020
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04975724
- Acronym / sponsor ID
- QQ05.16.02
- Conditions
- Major Depressive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fidia Farmaceutici s.p.a.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2019 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Liposom Forte + Citalopram | Experimental | Drug: Liposom Forte, Drug: CitalopramLiposom Forte (2 ampoules of 28mg/2 ml) for 30 days + citalopram (10mg) for 90 days |
| Group B Placebo + Citalopram | Experimental | Drug: Citalopram, Other: PlaceboPlacebo (2 ampoules of 2 ml) for 30 days + citalopram (10mg) for 90 days |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposom ForteAlso: LiposomLiposom 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). | Drug | Group A Liposom Forte + Citalopram |
| CitalopramThe 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 | Drug | Group A Liposom Forte + Citalopram, Group B Placebo + Citalopram |
| PlaceboAlso: Placebo of Liposom ForteLiposom Forte Placebo (2 ampoules of 2 ml solution for injection) | Other | Group B Placebo + Citalopram |
Primary outcome
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)
Time frame: Day 30 (V5)
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)
10 secondary outcomes
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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From baseline through 90 days follow-up (V8)
Safety of study treatments by tracking, up to V8 (Day 90), heart rate measurements in bpm
Time frame: From baseline through 90 days follow-up (V8)
Safety of study treatments by tracking, up to V8 (Day 90), oxygen saturation measurements in percentage with a pulse oximetry device
Time frame: From baseline through 90 days follow-up (V8)
Change of depressive symptoms during the entire study as change from baseline therapy with citalopram over the entire study
Time frame: From baseline through 90 days follow-up (V8)
Percentage of patients responders at V2, V3, V4 and V5. ≥50% improvement in HAM-D score vs baseline will be considered as responder.
Time frame: From baseline through 30 days follow-up (V5)
Change of depressive symptoms as change from baseline using Geriatric Depression Scale (GDS-15).
Time frame: From baseline through 90 days follow-up (V8)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Giordan study director
Fidia Farmaceutici s.p.a.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposom Forte and Citalopram in people with Major Depressive Disorder, run by Fidia Farmaceutici s.p.a. at 12 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicola Giordan, Dr (0039 049 8232512, ngiordan@fidiapharma.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Day 30 (V5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.