A Prospective Post Marketing Surveillance Study Study for the Evaluation of the Safety and Efficacy of the Predictix Antidepressant (PAD) Clinician Software Support Tool in Prescribing Antidepressant Medication/s for the Treatment of Patients Suffering From Major Depressive Disorder
试验速览
- 阶段
- 4 期
- 发起方
- Taliaz Ltd.
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- success rate of the Predictix tool
研究概览
简要总结
The study is designed as an open label, one arm study. Up to 30 eligible patients will be enrolled, for whom the Predictix Antidepressant Software tool will be used when prescribed with a medication for their Major Depressive Disorder, by their treating physician.
Visits will include the completion of several questionnaires designed to answer the study objectives, either as self-reported by the subjects and/ or by the clinician.
详细描述
The study will enroll up to 30 eligible patients, for whom the Predictix Antidepressant Software tool will be used when prescribed with a medication for their Major Depressive Disorder, by their treating physician.
A treatment cycle will include four to five visits: Information consent and oral sampling, Baseline, 4 and 8 weeks. At least one completed cycle per patient is required for a patient to be included in the analysis as study completed.
The treating physician will review and approve each subject's eligibility prior to his/ her entrance to the study and will review the Predictix Antidepressant software tool report prior to treatment start.
Visits will include the completion of the Taliaz Ltd. Physician Form and several questionnaires designed to answer the study objectives Usability and satisfaction questionnaire/s will be analyzed for Usefulness, Satisfaction, Ease of Use and Learnability of the system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female at the age of 18 - 75 years old
- •Indication of MDD diagnosis per DSM V
- •Rule out other causes of depressive symptoms other than MDD apart from General Anxiety Disorder as authentified by the MINI*) (by Sheehan and Lecrubier ).
- •*Up to a maximum of 15 completed GAD pts
- •Ability to read, understand and sign an informed consent document
排除标准
- •Patient is diagnosed with other major psychopathologies (i.e. schizophrenia, bipolar disorder, psychotic depression, geriatric depression)
- •Patient requires antipsychotic medication or mood stabilizers
- •Patient is at substantial suicidal risk as judged by the treating physician
- •Patient has attempted suicide in the past year.
- •Patient has any current unstable medical condition or surgical illness
- •Patient has history of seizure or convulsions.
- •Patient has history of drug abuse or alcoholism in the last 6 months
- •Inadequate communication with the patient
- •In the investigator's judgement, patient is not able to provide written informed consent
- •Pregnant women
结局指标
主要结局
success rate of the Predictix tool
时间窗: 8 weeks
A success will be defined as a score of 3 and below in the total improvement: measured by the CGI last measured value compared to Baseline, as well as a \>50% improvement measured by the QIDS16, under a specific medication cycle regimen.
次要结局
- Usability(8 weeks)