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

Completed · Phase 2

Conditions studied: Schizophrenia, Major Depressive Disorder, Bipolar I Disorder

In brief

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.

Key facts

Study ID

NCT02722967

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

49

Starts

2016-03-01

Expected to finish

2016-09-01

Last updated by the study team

2018-05-23

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Granada Hills, California, United States
• Study site — Rochester, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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