Homeopathy for Depression: a randomized, four-armed, partial double-blind study. - DEP-HOM

Institute for Social Medicine, Epidemiology, and Health Economics, Charité Berlin0 个研究点目标入组 228 人开始时间: 2010年3月24日最近更新: 2021年9月7日

适应症

试验速览

暂无简介。

•Male and female patients between 18 and 65 years
•Major Depression diagnose made by a psychiatrist
•Willingness to comply with study procedures
•Patients not using antidepressants or anxiolytic drugs (exception Lorazepam, maximal dose 1.5 mg/day as rescue medication)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•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

•mild depressive Episode: Hamilton Depression Score (HAM-D) < 17)
•severe depressive Episode (HAM-D > 24)
•Schizophrenia or other psychotic disorders, bipolar affective disorder, schizoaffective disorders, alcohol or other substance abuse, eating disorders
•clinically significant Axis II disorder
•presence of a clinically significant acute or chronic disease that would hinder the regular participation in the study
•a severe depression that has led to a suicide attempt in patients' history.
•suicidal ideation of type 4 oder 5 on the C-SSRS in the last month (i.e. active suicidal ideation with some intent to act, without specific plan; or active suicidal ideation with specific plan and intent)
•suicide thoughts according to an analysis made from a Psychiatrist
•treatment with antipsychotics, antidepressants or sedatives/hypnotics or mood stabilizers 4 weeks prior to study entry
•complementary or alternative treatment during the study (for example, acupuncture, phytotherapy, etc.)
•Homeopathic treatment 8 weeks prior study entry
•Psychotherapy
•patients who are assumed to have a linguistic, intellectual or any other reason for not understanding the meaning of the clinical study and for not complying with the necessary study procedures
•concomitant pregnancy or nursing
•patients with pending pension application
•persons who have been institutionalized by a court order

发起方

Institute for Social Medicine, Epidemiology, and Health Economics, Charité Berlin