EUCTR2017-004602-17-GB进行中（未招募）1 期
A Multicentre, 8-week, Single-arm, Open-label, Pragmatic Trial to Explore Acceptance and Performance of Using a Digital Medicine System with Healthcare Professionals and Adult Subjects with Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic (Aripiprazole, Olanzapine, Quetiapine, or Risperidone)
Otsuka Pharmaceutical0 个研究点目标入组 60 人开始时间: 2017年12月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 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
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1) Subject must be willing and able to give written (signed and dated) informed consent, which includes adherence to trial requirements and restrictions before enrolling in the trial. Subject must be willing to adhere to trial procedures, including troubleshooting of the DMS by a third party if needed.
- •2) Subject must be able to read and understand English.
- •3) Male and female subjects 18 to 65 years of age, inclusive,
- •at the time of informed consent.
- •4) Subject possessing a smartphone and being familiar with
- •its use and willing to download and interact with the DMS
- •app, completing all tasks as well as adequately operate all devices, as applicable. Caregiver/support person or other third party assistance can be utilised, if needed, although all subjects should be encouraged to attempt all tasks themselves.
- •5) Subject possesses the capacity to utilise the technology interfaces (eg, open and navigate software applications using the touch screen) and telephone features of a smartphone. The subject has satisfactory mobile phone reception (preferably 3 bars or more, or have Wi-Fi) at home and/or at work for trial-designated wireless carrier.
- •6) Subject is cooperative, able to ingest oral medication, willing to complete all aspects of trial, and capable of reporting AEs.
- •7) Clinical diagnosis of SCH or schizoaffective disorder
- •(defined by ICD-10 codes F20 and F25) or first episode
- •psychosis using case note review.
- •8) Subjects prescribed aripiprazole, olanzapine, quetiapine, or risperidone.
- •Subject must fulfill at least one or more of the following:
- •? Discharge from a hospital admission (within 7 days of
- •discharge) to an acute intervention team;
- •? Referral to an acute intervention team, prior to any
- •hospital admission;
- •? Referral from an acute intervention team to a
- •community team;
- •? Managed by community services (inclusive of patients
- •on Care Programme Approach);
- •? Inclusion within early intervention caseload (< 3 years
- •from initial symptoms);
- •? HCP determines the subject would benefit from using
- •10) Subject’s general medical condition such that participation
- •in the trial does not pose any additional risk as per HCP’s judgment.
- •11) Skin on the anterior chest just above the lower edge of the rib cage that is free of any dermatological problems (eg, dermatosis or dermatitis, open wounds, or other skin disorders such as warts, rashes, atopic dermatitis, or irritations).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)Subject with any disorder including but not limited to intellectual developmental delay or disorder, major
- •neurocognitive disorder or other condition that may impact the subject’s ability to participate in the trial or interact with the smartphone app.
- •2) Subject who is likely to be incapable of using the DMS technology, even with assistance.
- •3) Subject who has a history or evidence of a medical
- •condition that would expose them to an undue risk of a significant AE or interfere with assessments of safety or usability during the course of the trial, including but not limited to, hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease as determined by the clinical judgment of the HCP.
- •4) Subject with a known allergy to adhesive tape or any pertinent components of the patch or CoE product.
- •5) Prisoner must not be enrolled into this trial.
- •6) Subject who is hospitalised due to mental or physical
- •illness (inpatient) at the time of screening/baseline must
- •not be enroled into this trial.
- •7) Any subject who, in the opinion of the HCP, should not
- •participate in the trial.
- •8) Any subject who, through religious or lifestyle choices,
- •will not take gelatin capsules.
- •9) Female (females of childbearing potential [FOCBP]) who are breast-feeding and/or who have a positive pregnancy test result prior to receiving trial enrolment, or who plans to become pregnant during the trial.
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