ACTRN12622000610730招募中未知
Evaluating the feasibility and acceptability of a combined treatment for depression using a personalised psychosocial intervention and Vortioxetine in older adults.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 50 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Capacity to provide informed consent.
- •Aged between 50 – 75 years of age.
- •Able to see and hear, with or without sensory aids (e.g. glasses or hearing aids).
- •Has adequate English skills to participate.
- •Able to read and write.
- •Has a Medicare card and a regular General Practitioner.
- •Consents to the study team contacting their General Practitioner.
- •Consent to take Vortioxetine during the study.
- •Participants must not currently be taking anti-depressant medication.
- •Current moderate depressive symptoms as confirmed by the Mini International Neuropsychiatric Interview (MINI).
- •Depression symptom severity demonstrated as clinically significant (scores equaling or greater than 15) according to the Structured Interview Guide of the Hamilton Anxiety and Depression Scale (SIGH-AD).
- •Depression symptom severity demonstrated as mild-moderate (16-19), or moderate (20-35) according the Montgomery Asberg Depression Rating Scale (MADRS) (Svanborg & Asberg, 2001).
- •Reported duration of the current major depressive episode is at least 3 months.
- •Participant has either been told or self-reports they are currently experiencing depressive symptoms.
- •Participants must be willing and able to complete digital treatment tasks presented on a computer.
- •Participants must have access to the internet and a computer/laptop in a private space.
- •Study participant is willing to give blood samples during the study (at screening and week 2,as well as following any Vortioxetine dosage changes).
排除标准
- •Living in residential aged care (e.g. hostel or nursing home).
- •Current alcohol and/or substance use disorder (DSM-5).
- •Presence of a co-morbid psychiatric disorder other than mild to moderate depression that is a focus of clinical concern as confirmed by the MINI (e.g. schizophrenia or bipolar disorder).
- •Depression symptom severity demonstrated as severe (36-60) according the Montgomery Asberg Depression Rating Scale (MADRS).
- •People currently on antidepressant medication (except for Vortioxetine).
- •People who are pregnant, trying to get pregnant or breast-feeding.
- •People with active suicidality or a history of suicide attempt(s) within the past 2 years.
- •Brain injury, neurological condition or impairment which could affect cognitive function (e.g. neurodevelopmental disorders, neurodegenerative disease, dementia).
- •People currently taking medications approved for and/or employed off-label for cognitive dysfunction (e.g. psychostimulants).
- •People currently taking any medication for a general medical disorder that in the opinion of the investigator may affect cognitive function (e.g. corticosteroids, beta-blockers).
- •People currently on regular prescribed (i.e. not as needed” or PRN) antipsychotic or benzodiazepine medication.
- •People currently participating in a research drug trial.
- •Physical, cognitive or language impairment(s) of some severity as to adversely affect data derived from the THINC-It tool.
- •People who have received electroconvulsive therapy within the last 6 months (they may be invited to call back when 6 months have elapsed).
- •A history of unsuccessful Vortioxetine use and known allergies to Vortioxetine.
研究者
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