AzTrials
AzTrials

SchizophreniaPhase 2NCT02722967

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

A Phase 2 study testing Aripiprazole + IEM (Ingestible Event Marker) in people with Schizophrenia and Major Depressive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Aripiprazole + IEM (Ingestible Event Marker)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
4 sitesUnited States
Study dates
Mar 2016to Sep 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Study site

    Durham, North Carolina, 27714

  • Study site

    Granada Hills, California, 91344

  • Study site

    Richmond, Virginia, 23230

  • Study site

    Rochester, New York, 14603

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Aripiprazole + IEM (Ingestible Event Marker)
Medical subject headings
Schizophrenia, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aripiprazole + IEM (Ingestible Event Marker)Drug

    Also called MIND1, Digital Medicine System

    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.

Study groups in NCT02722967
Study groupRoleWhat they receive
Aripiprazole + IEMExperimentalSubjects 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.
Receives: Drug: Aripiprazole + IEM (Ingestible Event Marker)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: From baseline upto week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02722967
Sponsor's protocol ID
316-13-215
Status last verified
Apr 2018
First submitted
13 Mar 2016
Last updated
23 May 2018
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38085556

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aripiprazole + IEM (Ingestible Event Marker) in people with Schizophrenia and Major Depressive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: From baseline upto week 9). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02722967, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in