| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis |
|
| E.1.1.1 | Medical condition in easily understood language |
|
| E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 20.0 |
| E.1.2 | Level | HLGT |
| E.1.2 | Classification code | 10039628 |
| E.1.2 | Term | Schizophrenia and other psychotic disorders |
| E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
Explore the acceptance and performance of the digital
medicine system (DMS) with healthcare professionals (HCPs) and adult subjects with schizophrenia (SCH), schizoaffective disorder, or first episode psychosis. |
|
| E.2.2 | Secondary objectives of the trial |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
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). |
|
| E.4 | Principal exclusion criteria |
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. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary endpoint is the proportion of days with good patch coverage during the trial, which will be calculated by the number of days with good patch coverage divided by the total number of trial days for each subject. The good patch coverage is defined as having at least 80% patch data available or MITs detected within the 24-hour period for each day while the subject is on the trial. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| The good patch coverage is defined as having at least 80% patch data available or MITs detected within the 24-hour period for each day while the subject is on the trial. |
|
| E.5.2 | Secondary end point(s) |
| The secondary endpoint is subject’s adherence metric, which is the proportion of detected MITs over the expected MITs ingested during the trial days with good patch coverage. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Yes |
| E.6.13.1 | Other scope of the trial description |
| Explore Acceptance and Performance of Using a Digital Medicine System with Healthcare Professionals |
|
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.2.4 | Number of treatment arms in the trial | 4 |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | No |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| The end of trial date is defined as the last date of contact or the date of final contact attempt for the last subject completing or withdrawing from the trial. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
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