EUCTR2012-004627-20-DE进行中（未招募）不适用
Randomized double-blind, placebo controlled study with NEURAPAS® balance in addition to psychoeducation or psychotherapy in adolescents from 12 to 17 years suffering from mild depressive episodes with nervous restlessness
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male and female patients between 12 and 17 years of age
- •2.Mild depressive episode, single or recurrent (according to ICD: F32.0 or F33.0); differential diagnosis (according to AWMF-guideline Depressive Episoden und rezidivierende depressive Störungen (F32, F33), anhaltende affektive Störungen (F34)” and/or DGPPN guideline Unipolare Depression” has ruled out other psychiatric conditions and somatic/organic cause of depressive episode
- •3.Diagnosis of the depressive episode between 2 weeks and 3 months prior to baseline
- •4.Presence of: depressed mood, loss of interest and enjoyment, increased fatigability
- •5.CDRS-R = 35 and = 45
- •6.CGI Item 1 (severity of illness) = mildly ill”
- •7.Presence of nervous restlessness (patient is restless or agitated or stressed or feels driven and in addition is nervous since at least 2 weeks)
- •8.Concomitant psychoeducation or psychotherapy (e.g. but not limited to cognitive behavioral therapy or interpersonal therapy together with or without family therapy)
- •9.Based on the appraisal of the investigator: adequate educational as well as intelligence level and ability to communicate of patients, parents/legal guardians in order to fulfill the requirements of the trial
- •10.Written informed consent of the patients
- •11.Written informed consent of the parents/legal guardians
- •12.Negative pregnancy test at the baseline visit (prior to the first intake of study medication) for female patients.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 380
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria 1-11:
- •Manic or bipolar disorders,Psychotic depression,Anorexia, Bulimia, Borderline personality disorders, Attention deficit disorder or hyperactivity disorder, Evidence for drug or alcohol abuse, Schizophrenia, Schizoaffective disorders, Psychosis, Deliria
- •12. Current suicidal ideation (item „suicidal ideation on the CDRS-R = 4, 5, 6 or 7 or any other indication for current suicidal ideation)
- •13. Organic brain disorders
- •14. Known photosensitivity of the skin
- •15. Patients who did not respond to any prior antidepressive drug treatment
- •16. Currently taking or past intake during the last 4 weeks prior to baseline or planned prescription during the trial of: psychotropic or centrally acting drugs (including herbal preparations and homeopathic preparations) including but not limited to antidepressants, lithium, psychostimulating agents, sedatives, hypnotics, tranquilizers
- •17. Concomitant treatment with or planned prescription during the trial of: tacrolimus for systemic use, sirolimus, ciclosporin, non-nucleoside-reverse-transcriptase-inhibitors such as nevirapine, protease-inhibitors, anticoagulants, cytostatic agents such as imatinib, irinotecan except for monoclonal antibodies, theophylline, digoxin, ivabradine, verapamil, simvastatin
- •18. Planned or foreseeable change of the concomitant psychoeducation or psychotherapy (e.g. but not limited to cognitive behavioral therapy or interpersonal therapy with or without family therapy)
- •19. Any other non-drug treatment of the depression or the nervous restlessness except for the established concomitant psychoeducation or psychotherapy
- •20. Known hypersensitivity to the pharmacologic active constituents or any other ingredient of the study medication
- •21. Patients who currently receive a drug during a clinical trial or who have received a drug during a clinical trial within the last 30 days prior to inclusion
- •22. Patients who are hospitalized or in psychiatric care due to court or other authority order
- •23. Female patients
- •owho are pregnant or lactating
- •owho menstruate and are capable of becoming pregnant and who practice sexual intercourse and do not use a medically accepted method of contraception (Pearl-index < 1) during the study treatment and at least 4 weeks thereafter.
研究者
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