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)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- 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)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 84 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Group A Liposom Forte + Citalopram
Liposom Forte (2 ampoules of 28mg/2 ml) for 30 days + citalopram (10mg) for 90 days
干预措施: Liposom Forte (Drug)
Group A Liposom Forte + Citalopram
Liposom Forte (2 ampoules of 28mg/2 ml) for 30 days + citalopram (10mg) for 90 days
干预措施: Citalopram (Drug)
Group B Placebo + Citalopram
Placebo (2 ampoules of 2 ml) for 30 days + citalopram (10mg) for 90 days
干预措施: Citalopram (Drug)
Group B Placebo + Citalopram
Placebo (2 ampoules of 2 ml) for 30 days + citalopram (10mg) for 90 days
干预措施: Placebo (Other)
结局指标
主要结局
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)
时间窗: 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)
次要结局
- 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))
- 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))
- Change of depressive symptoms as change from baseline using Geriatric Depression Scale (GDS-15).(From baseline through 90 days follow-up (V8))
- 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), blood pressure measurements in mmHg(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))
- 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))
- Safety of study treatments by tracking, up to V8 (Day 90), heart rate measurements in bpm(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(From baseline through 90 days follow-up (V8))