Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis MedDRA version: 20.0 Level: HLGT Classification code 10039628 Term: Schizophrenia and other psychotic disorders System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Aripiprazole
Product Name: DM-Aripiprazole
Pharmaceutical Form: Tablet
Trade Name: Olanzapine
Product Name: DM-Olanzapine
Sponsors
Otsuka Pharmaceutical
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: Not applicable;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.;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.;Timepoint(s) of evaluation of this end point: during the whole trial | — |
Countries
United Kingdom
Contacts
Public ContactGlobal Clinical Development
Otsuka Pharmaceutical
Outcome results
None listed