NL-OMON23849招募中不适用
Digital biotyping of patients with unipolar depression.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
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 score of >22 at Screening.
- •6. Meeting one of the following conditions;
- •o no treatment with 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 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.
- •9. Android-based smartphone with Android version 5.0 or higher.
- •Healthy volunteers:
- •1. Written informed consent must be obtained before any assessment is performed.
- •2. Male or female subjects, 18 to 65 years (inclusive).
- •3. Body mass index (BMI) between 18 and 32 kg/m2.
- •4. Must read and speak Dutch as a first or second language.
- •5. Able to comply with the study procedures, prohibitions and restrictions (drug and alcohol use) as specified in the protocol.
- •6. Android-based smartphone with Android version 5.0 or higher.
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 antidepressant drugs (SSRI, SNRI, mirtazapine, TCA, MAO-I) or 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 ß-human chorionic gonadotropin (ß-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.
- •2. Positive alcohol breath test or urine test for drugs of abuse at Screening 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.
- •3. Evidence of any active or chronic disease or condition that could interfere with the conduct of the study.
- •4. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis).
- •In the case of uncertain or questionable results, tests performed during Screening may be repeated before inclusion to confirm eligibility or judged to be clinically irrelevant for healthy subjects.
- •5. Use of any medications (prescription or over-the-counter [OTC]), within 14 days of Visit 1, or less than 5 half-lives (whichever is longer). An exception is paracetamol (up to 2 g/day).
- •Other exceptions will only be made if the rationale is clearly documented by the investigator.
- •6. Positive urine ß-human chorionic gonadotropin (ß-hCG) pregnancy test at Screening in women of childbearing potential.
- •7. Wearing a pacemaker or other internal medical device (e.g. Vagus Nerve Stimulation (VNS), Deep Brain Stimulation (DBS)).
- •8. Current enrollment in another study.
研究者
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