Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02219009
Recruitment Status : Completed
First Posted : August 18, 2014
Results First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Tracking Information
First Submitted Date  ICMJE August 14, 2014
First Posted Date  ICMJE August 18, 2014
Results First Submitted Date  ICMJE July 16, 2018
Results First Posted Date  ICMJE August 15, 2018
Last Update Posted Date August 15, 2018
Study Start Date  ICMJE August 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
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 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 14, 2014)
Ability to replace and pair the patch independently and successfully by the end of the Week 8 study visit [ Time Frame: Baseline to Week 8 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2018)
  • 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. [ Time Frame: Baseline to Week 8 ]
    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.
  • Proportion of Time During the Study Period When Participants Wear Their Patches [ Time Frame: Baseline to Week 8 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2014)
Ability to wear the patch regularly [ Time Frame: Baseline to Week 8 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: August 14, 2014)
  • Assess the length of time needed for training subjects by the site, caregivers (if applicable), and others until the subject is able to replace and pair patch independently and successfully during the training phase at the study site [ Time Frame: Baseline to Week 8 ]
  • For subjects with caregivers, to assess how much support the subject needs from caregiver during the training and independent phases until the subject is able to replace and pair patch independently and successfully, as measured by a questionnaire scale [ Time Frame: Baseline to Week 8 ]
  • Assess levels of satisfaction of subjects and healthcare professionals as well as caregivers (as applicable) [ Time Frame: Baseline to Week 8 ]
  • Assess usability as perceived by subjects and healthcare professionals as well as caregivers (as applicable) [ Time Frame: Baseline to Week 8 ]
  • Assess the engagement of subjects during the study by measuring the proportion of time they are using the software application while wearing a patch [ Time Frame: Baseline to Week 8 ]
  • Assess the frequency that site staff accesses the healthcare professional portal [ Time Frame: Baseline to Week 8 ]
  • Assess the support needed from the Call Center [ Time Frame: Baseline to Week 8 ]
  • Assess the proportion of IEMs registered on the digital health data server versus [ Time Frame: Baseline to Week 8 ]
  • Assess the safety and tolerability of the MIND1 system, as assessed by the frequency and severity of AEs, device-related AEs, SAEs, AEs leading to discontinuation, and unanticipated adverse device effects [ Time Frame: Baseline to Week 8 ]
 
Descriptive Information
Brief Title  ICMJE Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Mental Disorder
  • Nervous System Diseases
Intervention  ICMJE Device: MIND1 System
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.
Other Name: OPC-14597 Digital
Study Arms  ICMJE Experimental: MIND1 System
Intervention: Device: MIND1 System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2016)
67
Original Estimated Enrollment  ICMJE
 (submitted: August 14, 2014)
32
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02219009
Other Study ID Numbers  ICMJE 316-14-220
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Timothy Peters-Strickland, MD Otsuka Pharmaceutical Development & Commercialization, Inc.
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP