Hippocampal Volume in Young Patients With Major Depression Before and After Combined Antidepressive Therapy - a Monocentric, Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Categorial response to the medication. Categorial response is defined on the basis of CGI Improvement scale and 50% reduction in MADR-S score
研究概览
简要总结
The proposed study is a randomized, placebo-controlled, double-blind trial to evaluate the safety and efficacy of antidepressant combination for the treatment of depression.
Depressive disorder is one of the most common human diseases with a high burden for every patient, her/his family, health care system and society as a whole. Actual treatment concepts of depressive disorders include pharmacologic, biologic (e.g. electroconvulsive therapy, light therapy) and psychologic therapy. Even though effective therapeutic options are at hand, therapy needs time. It is often not possible to reach full remission of the disease and 10-25% of patients suffering from depression are regarded as "treatment-resistant". In treatment resistant depression, the use of a combination of antidepressive drugs is considered safe and effective. However, at present no data exist concerning the use of drug combination as primary therapeutic option. The aim of the study is to examine the hypothesis, that significantly more patients achieve full remission of depressive symptoms when treated with the combination of two antidepressants and as a secondary hypothesis, that patients receiving a drug combination will achieve remission faster than patients treated with monotherapy. To test these hypotheses, a two group parallel design is used comparing the efficacy and safety of mirtazapine in combination with venlafaxine or placebo.
详细描述
Background Information
Combining antidepressants is a well-established medical procedure for the treatment of therapy refractory depression, that may also be applied successfully under non-refractory conditions. The goal of the study is to test this hypothesis. All participants are to be treated with Remergil Soltab®, a sedative antidepressant containing mirtazapine. In a double-blind, parallel-group design, all participants are treated with either Trevilor® retard, an antidepressant of the selective-serotonin-norepinephrine-reuptake-inhibitor class containing venlafaxine or placebo.
Especially in the treatment of therapy-resistant depression augmentation- and combination strategies are widely used (Demling and Frieling 2004).
Only limited data exist on the efficacy and safety of combination of antidepressants: Carpenter et al. have shown, that adjunctive use of mirtazapine added to the prior used antidepressant (mostly SSRIs) was more effective than placebo (Carpenter et al 2002). Devarajan and Dursun report a more effective antidepressive therapy with the combination of citalopram and reboxetine (Devarajan and Dursun 2000). Rubio et al. found the combination of reboxetine, SSRI or venlafaxine and mirtazapine effective (Rubio et al 2004). Smith et al. report less side effects of venlafaxine use when combined with mirtazapine.
All mentioned studies were conducted in treatment-resistant depression. Only the study by Carpenter et al. was done in a randomized, controlled, double-blind design. No data exist on the efficacy and safety of combined antidepressant use as primary therapy of depression.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men aged 18-55 years
- •Moderate to severe depressive episode according to ICD10-criteria ICD10:F32.1, F32.2, F33.1, F33.2) and MADRS-sum value >=18 points
排除标准
- •Bipolar affective disorder incl. BD-II.
- •Psychiatric or neurologic comorbidity.
- •Depression with psychotic symptoms.
- •Pregnancy or lactation period.
- •Significant cardiovascular or gastrointestinal disease.
- •Severe dysfunction of liver (defined according to Child-Pugh-Criteria (>=Child A)) or kidney (defined according to KDIGO stage I (albuminuria >=30mg/g).
- •Known and proven pharmacoresistance.
- •Proven contraindication against MRI (e.g. pacemaker).
- •Known incompatibility against one of the substances used.
- •Intake of irreversible inhibitors of monoamine oxidase (MAOI, e.g. tranylcypromine) during last 14 days.
- •Known phenylketonuria.
- •Women with childbearing potential not using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner).
研究组 & 干预措施
1
Probands receive mirtazapine and venlafaxine
干预措施: Venlafaxine (Drug)
2
Patients receive mirtazapine and placebo
干预措施: Mirtazapine (Drug)
结局指标
主要结局
Categorial response to the medication. Categorial response is defined on the basis of CGI Improvement scale and 50% reduction in MADR-S score
时间窗: Whole duration of study
次要结局
- Tolerability of treatment as assessed using the DOTES scale(Whole duration of study)
- Cognitive deficits as judged by the SKT system(Study duration)
- Self assessment of depression and anxiety using Beck's Depression/Anxiety Inventory (BDI/BAI)(Whole study)
- Changes is blood levels of homocysteine, folate, vit B12, P11(whole study duration)