Clinical trial NCT02722967: Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Major Depressive Disorder
Bipolar I Disorder
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-30
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: 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.
timeFrame: From baseline upto week 9
Secondary outcomes:
Other outcomes:
Locations:
city: Granada Hills
country: United States
state: California
city: Rochester
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Otsuka Pharmaceutical Development & Commercialization, Inc.
name: Tim Peters-Strickland, M.D.
role: STUDY_DIRECTOR
References: