Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System

Otsuka

Status and phase: Completed; Phase 2

Conditions: Major Depressive Disorder; Bipolar I Disorder; Schizophrenia

Treatments: Drug: Aripiprazole + IEM (Ingestible Event Marker)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02722967

316-13-215

Details and patient eligibility

About

This study will assess the helpfulness of the integrated call center in optimizing use of the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder taking oral aripiprazole.

Full description

The Digital Medicine System includes a drug-device combination of aripiprazole + an ingestible event marker (IEM), a wearable sensor (skin patch), and application software to convey the level of activity and rest, and to mark events through the act of ingestion.

Physician and self-report are the most commonly used to assess medication compliance yet studies have consistently found that healthcare providers' subjective judgments of medication compliance are often inaccurate, with a tendency for practitioners to overestimate subject adherence. The sponsor's intent is to develop a system that will benefit future subjects by providing the ability to measure their medication-taking behavior in an objective manner and being able to monitor several physiologic parameters.

Enrollment: 49 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Aripiprazole + IEM

Experimental group

Description:

Subjects will receive an intervention consisting of a drug-device combination that consists of an aripiprazole tablet with a tiny sensor embedded within it referred to as an Ingestible Event Marker (IEM) . They will discontinue their normally prescribed oral aripiprazole tablets and will take the aripiprazole(2, 5, 10, 15, 20, or 30 mg) + IEM once daily for the 8-week assessment period for this trial.

Treatment:

Drug: Aripiprazole + IEM (Ingestible Event Marker)