Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT02722967
Eligibility Criteria:
Inclusion Criteria:
* Primary diagnosis of Schizophrenia (SCH), Major Depressive Disorder (MDD), or Bipolar 1 Disorder (BP1), per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* Must be able to swallow tablets
* Currently taking a stable daily dose of oral aripiprazole
* Must have capacity to utilize the technology
* Skin in area of patch application must be free of any skin disorders or dermatological problems
Exclusion Criteria:
* Subjects using long acting injectable antipsychotic medications
* Subjects likely to be incapable of using the Digital Medicine System even with assistance
* Subjects who present serious risk of suicide
* History of epilepsy or seizures
* History of hypersensitivity to antipsychotic agents, adhesive tape or any component of the sensor skin patch or ingestible event marker
* Current history of substance use disorder meeting DSM-5 criteria
* Subject with unstable mood, acute psychosis or exhibiting symptoms requiring hospitalization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02722967
Study Brief:
Protocol Section:
NCT02722967