Digital Medicine System
- Conditions
- Schizophrenia, Schizoaffective Disorder, or First Episode PsychosisMedDRA version: 20.0 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders System Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2017-004602-17-GB
- Lead Sponsor
- Otsuka Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
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
DMS.
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method