A Prospective, Randomized, Controlled Study to Evaluate the Safety and Efficacy of the Predictix Antidepressant Clinician Support Tool in Prescribing Antidepressant Medication for the Treatment of Patients Diagnosed With Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 发起方
- Taliaz Ltd.
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Overall Response rate in the PGT and SOC groups
研究概览
简要总结
The study will compare two groups of patients: a control group of patients treated per the Standard of Care when prescribed with a medication for their Major depression disorder, versus a group of patients that used the Predictix Antidepressant tool when prescribed with a medication for their Major depression disorder by their treating physician. Success will be measured by the number (proportion) of responders per group.
详细描述
The study will be comprised of two arms:
- PGT arm - Predictix Antidepressant-guided treatment condition
- SOC (control) arm - Standard of Care condition Eligible subjects will be assigned to one of the study arms at a 1:1 ratio and will be followed for a period of 12 weeks.
An assigned psychiatric expert will review and approve subject's eligibility prior to entrance to the study, as well as, the medication/s prescribed based on the Predictix report prior to treatment start.
During the 12 weeks of follow up , data will be collected at the following timepoints: Screening, Baseline (start of treatment) and at 4, 8 and 12 weeks.
Visits will include the completion of several questionnaires designed to answer the study objectives, either as self-reported by the patients and/ or by the physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 at time of screening.
- •MDD diagnosis per DSM V at screening visit or prior to screening visit.
- •Rule out other causes of depressive symptoms other than MDD.
- •Ability to read, understand and sign an informed consent document
- •Female subjects at reproductive age that are tested negative for pregnancy
- •Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods during the whole study duration
排除标准
- •Patient is currently on an antidepressant treatment.
- •Patient is diagnosed with other major psychopathologies (i.e. schizophrenia, bipolar disorder, psychotic depression, geriatric depression).
- •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.
- •Patient has participated in another clinical study in the last 30 days preceding this study.
- •In the investigator's judgement, patient is not able to provide written informed consent and follow protocol requirements.
结局指标
主要结局
Overall Response rate in the PGT and SOC groups
时间窗: 12 weeks
Overall Response rate with and without the use of the Predictix Antidepressant software tool. Response is measures as at least 45% reduction in symptoms severity, measured by the Quick Inventory of Depressive Symptomatology (QIDS 16)
次要结局
- Usability and satisfaction of the Predictix tool(12 weeks)
- Economic burden* and social impact on patients, employers, the health system and payers(12 month)
- Change from baseline in Quick Inventory of Depressive Symptomatology( QIDS 16) self reported score(12 weeks)