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

NCT02722967 | Completed Phase 2 Results

• 1 other identifier: 316-13-215
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 4

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.

Conditions

Schizophrenia; Major Depressive Disorder; Bipolar I Disorder

Outcome Measures

Primary Outcomes (1)

• 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: 1. Inbound calls (ie, calls from the subject to the integrated call center) by help type; 2. 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

Study Arms (1)

Aripiprazole + IEM

EXPERIMENTAL

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.

Drug: Aripiprazole + IEM (Ingestible Event Marker)

Interventions

Aripiprazole + IEM (Ingestible Event Marker) DRUG

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.

Also known as: MIND1, Digital Medicine System

Aripiprazole + IEM

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (4)

Unknown Facility

Granada Hills, California, 91344, United States

Location

Unknown Facility

Rochester, New York, 14603, United States

Location

Unknown Facility

Durham, North Carolina, 27714, United States

Location

Unknown Facility

Richmond, Virginia, 23230, United States

Location

Related Publications (1)

• Jan M, Coppin-Renz A, West R, Gallo CL, Cochran JM, Heumen EV, Fahmy M, Reuteman-Fowler JC. Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials. JMIR Form Res. 2023 Dec 12;7:e44768. doi: 10.2196/44768.

  PMID: 38085556 DERIVED

MeSH Terms

Conditions

Schizophrenia; Depressive Disorder, Major

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Global Clinical Development
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

DT-inquiry@otsuka.jp

Study Officials

• Tim Peters-Strickland, M.D.

  Otsuka Pharmaceutical Development & Commercialization, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2016
• First Posted: March 30, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 23, 2018
• Results First Posted: May 23, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)