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

Schizophrenia Clinical Trial

Official title:

A Multicenter, 8-week, Open-label, Single-Arm Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System by Adult Subjects With Schizophrenia, Major Depressive Disorder, or Bipolar 1 Treated With Oral Aripiprazole

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722967
• Other study ID #: 316-13-215
• Status: Completed
• Phase: Phase 2
• Start date: March 2016
• Est. completion date: September 2016

Study information

• Verified date: April 2018
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar I Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Schizophrenia

Intervention

Drug:
• Aripiprazole + IEM (Ingestible Event Marker)
Oral aripiprazole (2, 5, 10, 15, 20, or 30 mg) with an ingestible event marker in a single daily dose for duration of the trial.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the Functionality of an Integrated Call Center for DMS by Adult Subjects With SCH, MDD, or BP1 Who Were Treated With Oral Aripiprazole.	The primary outcome was assessed as the establishment of a functional and operational integrated call center with coordinated feedback to the subject and investigative site to optimize the use of DMS as measured by: Inbound calls (ie, calls from the subject to the integrated call center) by help type; Outbound calls (ie, calls from the integrated call center to the subject) by help type.; The number presented in the table is the number of subjects in trial who made (inbound) or received (outbound) calls	From baseline upto week 9