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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Treatments: Aripiprazole

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