NL-OMON48415
已完成
不适用
An exploratory study to biotype adult patients with unipolar depression using digital technologies - Digital biotyping of patients with unipolar depression
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Unipolar depression
- 发起方
- Centre for Human Drug Research
- 入组人数
- 60
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Written informed consent must be obtained before any assessment is performed.
- •2\. Males and females, age 18 to 65 years (inclusive).
- •3\. Body mass index (BMI) between 18 and 32 kg/m2\.
- •4\. Primary diagnosis of moderate to severe major depressive disorder (MDD) without psychotic features or persistent depressive disorder (PDD)/dysthymia according to the DSM\-IV or DSM\-5, as diagnosed by the attending general practitioner, psychiatrist or clinical psychologist and confirmed with the Mini International Neuropsychiatric Interview (MINI) version 7\.0\.
- •5\. Total MADRS\-SIGMA total score of \>22 at Screening.
- •6\. Meeting one of the following conditions;
- •o no treatment with mono\-aminergic antidepressant drugs (SSRI, SNRI, mirtazapine, TCA, MAO\-I) and/or lithium for at least 2 weeks (6 weeks for fluoxetine) before Screening; or
- •o treatment with mono\-aminergic antidepressant drugs (SSRI, SNRI, mirtazapine, TCA, MAO\-I), with or without lithium, at a stable dose for at least 4 weeks prior to Screening (6 weeks for fluoxetine)
- •7\. Must read and speak Dutch as a first or second language.
- •8\. Able to comply with the study procedures, prohibitions and restrictions (drug and alcohol use) as specified in the protocol.
排除标准
- •1\. Current or previously diagnosed psychotic disorder, bipolar disorder, mental retardation, cluster B personality disorder (i.e. borderline, antisocial, narcissistic or histrionic personality disorders).
- •2\. Clinically significant suicidality within the past 6 months as demonstrated with the C\-SSRS or as judged by the investigator.
- •3\. Use of sedative medication started within 2 weeks before Visit 1 and/or daily use of benzodiazepines with a dose equivalent of more than 10 mg Diazepam.
- •4\. Foreseeable alterations in the dose of mono\-aminergic antidepressant drugs (SSRI, SNRI, mirtazapine, TCA, MAO\-I) and lithium during the course of the study.
- •5\. Positive alcohol breath test or urine test for drugs of abuse at Screening (positive urine test for benzodiazepines is allowed) or a current diagnosis of substance use disorder (including alcohol but excluding nicotine), or previous substance use disorder (including alcohol but excluding nicotine) within the past 12 months according to DSM\-IV or DSM\-5\.
- •6\. Evidence of any active or chronic disease or condition that could interfere with the conduct of the study.
- •7\. Positive urine \*\-human chorionic gonadotropin (\*\-hCG) pregnancy test at Screening in women of childbearing potential.
- •8\. Wearing a pacemaker or other internal medical device (e.g. Vagus nerve stimulation (VNS), Deep Brain Stimulation (DBS)).
- •9\. Current enrollment in another study.;Healthy volunteers:
- •1\. Current or previous clinically relevant history or family history of psychiatric disorders, neurological disorders or neurosurgery.
结局指标
主要结局
未指定
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