Major Depressive Disorder
Conditions
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.
Interventions
DRUGLiposom Forte
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).
DRUGCitalopram
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
OTHERPlacebo
Liposom Forte Placebo (2 ampoules of 2 ml solution for injection)
Sponsors
Fidia Farmaceutici s.p.a.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 84 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) | From baseline through 90 days follow-up (V8) | 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 | From baseline to Day 14 (V3) and Day 90 (V8) | To assess the safety of study treatments |
| Safety of study treatments by tracking, up to V8 (Day 90), blood pressure measurements in mmHg | From baseline through 90 days follow-up (V8) | To assess the safety of study treatments tracking blood pressure measurement in mmHg |
| 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) | 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) |
| Safety of study treatments by tracking, up to V8 (Day 90), oxygen saturation measurements in percentage with a pulse oximetry device | From baseline through 90 days follow-up (V8) | 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 | From baseline through 90 days follow-up (V8) | 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. | From baseline through 30 days follow-up (V5) | determine if Liposom Forte will speed up response to antidepressant therapy with citalopram |
| Change of depressive symptoms as change from baseline using Geriatric Depression Scale (GDS-15). | From baseline through 90 days follow-up (V8) | 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. |
| Safety of study treatments by tracking, up to V8 (Day 90), heart rate measurements in bpm | From baseline through 90 days follow-up (V8) | To assess the safety of study treatments tracking heart rate |
Countries
Italy
Contacts
Primary ContactNicola Giordan, Dr
Outcome results
None listed