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

NCT02219009 | Completed Phase 2 Results

• 1 other identifier: 316-14-220
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Schizophrenia; Mental Disorder; Nervous System Diseases

Keywords

OPC-14597 Digital; Aripiprazole; Medical Information Device #1 System (MIND1); Treatment Adherence; Ingestible Event Marker

Outcome Measures

Primary Outcomes (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.

  Baseline to Week 8

Secondary Outcomes (2)

• 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.

  Baseline to Week 8

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

  Baseline to Week 8

Study Arms (1)

MIND1 System

EXPERIMENTAL

Device: MIND1 System

Interventions

MIND1 System DEVICE

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.

Also known as: OPC-14597 Digital

MIND1 System

Eligibility Criteria

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

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (6)

Unknown Facility

Cerritos, California, 90703, United States

Location

Unknown Facility

Garden Grove, California, 92845, United States

Location

Unknown Facility

Oceanside, California, 92056, United States

Location

Unknown Facility

Atlanta, Georgia, 30331, United States

Location

Unknown Facility

Chicago, Illinois, 60640, United States

Location

Unknown Facility

St Louis, Missouri, 63141, 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; Mental Disorders; Nervous System Diseases; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Health Behavior; Behavior

Results Point of Contact

• Title: Global Medical Affairs
• Organization: Otsuka Pharmaceutical Development and Commercialization, Inc.

800 562-3974

Study Officials

• Timothy Peters-Strickland, MD

  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: August 14, 2014
• First Posted: August 18, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 15, 2018
• Results First Posted: August 15, 2018

Record last verified: 2018-07

Locations

US (6)