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SchizophreniaPhase 2NCT02219009

Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole

A Phase 2 study testing MIND1 System in people with Schizophrenia and Mental Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 6 sites in United States.

Completed

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

Official record
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Trial summary

The purpose of this study is to determine the usability of the Medical Information Device #1 (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
MIND1 System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
6 sitesUnited States
Study dates
Aug 2014to Jul 2015
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

  • Subjects must be prepared and able to give written (signed and dated) informed consent, which includes adherence to study requirements and restrictions before enrolling in the study. Subjects must be willing to adhere to study procedures, including troubleshooting of the MIND1 System by a third party if needed (third party will be blinded to personal health information).
  • Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
  • Subjects who have a primary current diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria. Subjects may be symptomatic at screening, but must be able to be treated as outpatients.
  • Subject is cooperative, able to ingest oral medication, and willing to complete all aspects of study.
  • Subject is currently prescribed oral aripiprazole for schizophrenia at one of the following single daily doses (10, 15, 20, or 30 mg), and is deemed likely to remain on this same stable dose throughout the course of the study. Subject has not had any changes in their aripiprazole regimen or dose over the 2 weeks before screening.
  • Subject must be able and willing to carry the MIND1 System smartphone on his/her person and complete all tasks, as well as adequately operate all devices, as applicable. Caregiver or other third-party assistance can be utilized, if needed, although all subjects should be encouraged to attempt all tasks themselves.
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  • Subject likely possesses the capacity to utilize the technology interfaces (eg, open and navigate software applications using the touch screen) and telephone features of a smartphone. The subject has satisfactory mobile phone reception (preferably 3 bars or more, or have Wi-Fi) at home and/or at work for study-designated wireless carrier.
  • Subject is not pregnant or breast-feeding, and does not plan to become pregnant.
  • Skin on the anterior chest just above the lower edge of the rib cage that is free of any dermatological problems (eg, dermatosis or dermatitis, open wounds, or other skin disorders such as warts, rashes, atopic dermatitis, or irritations).

Who cannot join

  • Subjects with a current DSM-5 diagnosis other than schizophrenia, including major depressive disorder, bipolar disorder, schizoaffective disorder, delirium, major neurocognitive disorder (eg, dementia), intellectual developmental disorder, or any other diagnosis that might impact the subject's ability to participate in the study. Other disorders that are not the focus of treatment and will not impact the subject's ability to participate in all aspects of the study (eg, social anxiety disorder) may be included.
  • Subjects with a current DSM-5 diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder.
  • Subjects who exhibit prominent negative symptoms that, in the judgment of the investigator, will interfere with study procedures or unable to adhere with study requirements.
  • Subjects who are currently on a long-acting injectable antipsychotic.
  • Subjects who are likely to be incapable of using the MIND1 System technology, even with assistance.
  • On the Columbia-Suicide Severity Rating Scale (C-SSRS) Subjects who answer "Yes" to Suicidal Ideation Item 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) and whose most recent episode meeting criteria for this C-SSRS Item 4 occurred within the last 3 months, OR Subjects who answer "Yes" on the C-SSRS Suicidal Ideation Item 5 (Active Suicidal Ideation with Specific Plan and Intent) and whose most recent episode meeting criteria for this C-SSRS Item 5 occurred within the last 3 months, OR Subjects who answer "Yes" on any of the 5 C-SSRS Suicidal Behavior Items (actual attempt, interrupted attempt, aborted attempt, preparatory acts, or behavior) and whose most recent episode meeting criteria for any of these 5 C-SSRS Suicidal Behavior Items occurred within the last 1 year, OR Subjects who, in the opinion of the investigator, present a serious risk of suicide.
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  • Subject has received any investigational product within the last 30 days, including the MIND1 System (eg, subjects who participated in Cohort 1 of this study are not eligible for Cohort 2).
  • Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant AE or interfere with assessments of safety or usability during the course of the study, including but not limited to, hepatic, renal, respiratory, cardiovascular, endocrine, neurologic, hematologic, or immunologic disease, as determined by the clinical judgment of the investigator.
  • Subjects with epilepsy or a history of seizures (except for a single childhood febrile seizure, post traumatic seizure, alcohol withdrawal seizure, etc).
  • Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia, as assessed by the investigator.
  • Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
  • Subjects with a history of hypersensitivity to antipsychotic agents.
  • Subjects with a known allergy to adhesive tape or any pertinent components of the patch or IEM
  • Sexually active women of childbearing potential who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during this study and for 30 days following the last dose of study medication.
  • Sexually active males (unless sterile, defined as having had a bilateral orchiectomy) who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the study and for 90 days following the last dose of study drug.
  • Subject has a current history (within the past month) of a substance use disorder (excluding tobacco) which meets DSM-5 criteria, or demonstrates a positive result on the urine drug test during screening. Subjects with a positive drug screen for drugs of abuse (excluding cannabinoids) are excluded and may not be retested or rescreened. Subjects with a positive urine drug screen resulting from use of prescription (such as opioids) or over-the-counter medications or products that, in the investigator's documented opinion, do not signal a clinical condition that would impact the safety of the subject or interpretation of the study results may continue evaluation for the study following consultation and approval by the Medical Monitor.
  • Subjects who, in the opinion of the investigator, are acutely psychotic or who exhibit symptoms currently requiring hospitalization.
  • Subjects unwilling to refrain from the use of topical products on the skin patch sites.
  • Subjects unwilling or unable to complete the evaluations included in this study, which include audio recording of the subject's voice and require the ability to distinguish colors (eg, subjects unwilling to be recorded and colorblind subjects are to be excluded from participation in this study)
  • Any subject who, in the opinion of the investigator, should not participate in the study.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Study site

    Atlanta, Georgia, 30331

  • Study site

    Cerritos, California, 90703

  • Study site

    Chicago, Illinois, 60640

  • Study site

    Garden Grove, California, 92845

  • Study site

    Oceanside, California, 92056

  • Study site

    St Louis, Missouri, 63141

Other trials in United States

About this study

Official title: A Multicenter, 8-week, Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adult Subjects With Schizophrenia Who Are Treated With Oral Aripiprazole

The purpose of this study is to determine the usability of the Medical Information Device #1 (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole.

Read the detailed description

Poor adherence to medication is a well-recognized problem in psychiatric patients. Although a variety of treatment models have been developed to improve management of patients in general and medication adherence in particular, poor medication adherence remains a major barrier to achieving optimal health.

The MIND1 System includes a drug-device combination, a patch, and application software to convey level of activity and rest and to mark events through the act of ingestion.

The purpose of this open-label study is to determine the usability of the Medical Information Device #1 (MIND1) System in adults with schizophrenia. Approximately 32 subjects with schizophrenia, between 18 and 65 years of age (inclusive) who are currently prescribed and stabilized on oral aripiprazole, will be enrolled.

Being tested
MIND1 System
Keywords
OPC-14597 Digital, Aripiprazole, Medical Information Device #1 System (MIND1), Treatment Adherence, Ingestible Event Marker
Medical subject headings
Schizophrenia, Mental Disorders, Nervous System Diseases, Treatment Adherence and Compliance

What participants receive

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

  • MIND1 SystemDevice

    Also called OPC-14597 Digital

    Subjects will receive aripiprazole tablets embedded with an IEM. They will discontinue their normally prescribed oral aripiprazole tablets and will take the aripiprazole + IEM tablets (eg, at the previously prescribed dose) during the 8-week treatment period for this study. Aripiprazole + IEM tablets must be taken on a once-daily dosing schedule.

Study groups in NCT02219009
Study groupRoleWhat they receive
MIND1 SystemExperimentalNot described
Receives: Device: MIND1 System

What is being measured

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

  1. Proportion of Participants Who Are Able to Pair & Apply a Patch Independently & Successfully by the End of the Week 8 Study Visit as Defined by a Score of 91 to 100 on the Subject Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP)

    Proportion of participants who are able to pair and apply a patch independently and successfully by the end of the Week 8 study visit (or early termination, if applicable), as defined as a score of 91 to 100 on the participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP). A participant was considered to have successfully and independently applied a patch if the SAUSS-HCP was at least 91 for at least one postbaseline score.

    Measured: Baseline to Week 8

Secondary outcomes (2)

  1. Proportion of Participants Able to Pair & Apply a Patch Successfully, Independently, or With Minimum Assistance, by the End of the Week 8 Study Visit, as Defined by a SAUSS-HCP Score of 71 to 100.

    Proportion of participants who are able to pair and apply a patch successfully, independently, or with minimum assistance, by the end of the Week 8 study visit (or early termination, if applicable), as defined by a Participant's Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP) score of 71 to 100. Participants were considered to have paired and applied a patch independently or with minimal assistance if their SAUSS-HCP score was at least 71 for at least one postbaseline score.

    Measured: Baseline to Week 8

  2. Proportion of Time During the Study Period When Participants Wear Their Patches

    Proportion of time during the study period when participants wear their patches; the time duration of patch wearing will be calculated based on digital health data. Percentage of participants' patch wearing time was calculated as (total duration a patch was worn / trial duration) x 100.

    Measured: Baseline to Week 8

Timeline

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

  1. First posted18 Aug 2014 (estimated)
  2. Study startAug 2014
  3. Primary completionJul 2015
  4. Study completionJul 2015

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
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02219009
Sponsor's protocol ID
316-14-220
Status last verified
Jul 2018
First submitted
14 Aug 2014
Last updated
15 Aug 2018

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 MIND1 System in people with Schizophrenia and Mental Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 6 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 9 inclusion and 20 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 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 15 Aug 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?

Proportion of Participants Who Are Able to Pair & Apply a Patch Independently & Successfully by the End of the Week 8 Study Visit as Defined by a Score of 91 to 100 on the Subject Ability to Use System Scale - Healthcare Professional Version (SAUSS-HCP) (time frame: Baseline to Week 8). 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 NCT02219009, 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 15 Aug 2018.

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