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A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic

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ClinicalTrials.gov Identifier: NCT03568500
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
Digital medicine systems (DMS) have been designed to assist individuals with the management of their daily health, wellness, and medication use. The DMS is being developed as a healthcare management tool to precisely measure medication adherence, and to potentially enhance adherence.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder First Episode Psychosis Device: Digital Medicine System Drug: Aripiprazole Drug: Olanzapine Drug: Quetiapine Drug: Risperidone Phase 4

Detailed Description:
The advancements in the treatment of mental health patients with DMS will enable healthcare professionals (HCPs) to assess suboptimal adherence and make more informed treatment decisions. In addition to these improvements, it will also provide a platform for engagement between subjects, HCPs, and caregivers/support persons.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Multicentre, 8-week, Single-arm, Open-label, Pragmatic Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adult Subjects With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic (Aripiprazole, Olanzapine, Quetiapine, or Risperidone)
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020


Arm Intervention/treatment
Experimental: Aripiprazole
A CoEncapsulated (CoE) aripiprazole, DMS patch & associated smartphone application.
Device: Digital Medicine System
A CoE containing an approved antipsychotic medication enclosed with an ingestible sensor pill

Drug: Aripiprazole
Oral tablet; dosage will be determine by the health care providers and is independent from the protocol

Experimental: Olanzapine
A CoEncapsulated (CoE) olanzapine, DMS patch & associated smartphone application.
Device: Digital Medicine System
A CoE containing an approved antipsychotic medication enclosed with an ingestible sensor pill

Drug: Olanzapine
Oral tablet; dosage will be determine by the health care providers and is independent from the protocol

Experimental: Quetiapine
A CoEncapsulated (CoE) quetiapine, DMS patch & associated smartphone application.
Device: Digital Medicine System
A CoE containing an approved antipsychotic medication enclosed with an ingestible sensor pill

Drug: Quetiapine
Oral tablet; dosage will be determine by the health care providers and is independent from the protocol

Experimental: Risperidone
A CoEncapsulated (CoE) risperidone, DMS patch & associated smartphone application.
Device: Digital Medicine System
A CoE containing an approved antipsychotic medication enclosed with an ingestible sensor pill

Drug: Risperidone
Oral tablet; dosage will be determine by the health care providers and is independent from the protocol




Primary Outcome Measures :
  1. Good Patch Coverage [ Time Frame: Up to 8 weeks ]
    80% patch data available or Ingestible Sensor Pills (MITs) detected within the 24-hour period for each day while subject is involved with the trial.


Secondary Outcome Measures :
  1. Subject Adherence [ Time Frame: Up to 8 weeks ]
    Detected MITs over expected MITs digested during the trial with good patch coverage.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is prescribed aripiprazole, olanzapine, quetiapine, or risperidone.
  • Subject possessing a smartphone and willing to download and interact with the DMS app.
  • Skin on the anterior chest just above the lower edge of the rib cage is free of any dermatological problems (e.g. open wounds, warts, rashes, atopic dermatitis, etc.

Exclusion Criteria:

  • Subject with a known allergy to adhesive tape or any pertinent components of the patch or CoE product
  • Prisoners cannot be enrolled into this trial
  • Subject who is hospitalized due to mental or physical illness (inpatient) at the time of screening/baseline
  • Any subject who, through religious or lifestyle choices, will not take gelatin capsules.
  • Female of childbearing potential who is breast-feeding and/or who have a positive pregnancy test result prior to receiving trial enrollment, or who plans to become pregnany during the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03568500


Locations
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United Kingdom
Surrey and Borders Partnership NHS Foundation Trust Recruiting
Chertsey, United Kingdom, KT160AE
Contact: Ward Lawrence, M.D.    01932 722247    research@sabp.nhs.uk   
South London and Maudsley NHS Foundation Trust Recruiting
London, United Kingdom, SE59RS
Contact: Sukhi Shergill, M.D.    0207 848 0029    sukhi.shergill@kcl.ac.uk   
Contact: Tracy Collier    0207 848 0029    tracy.1.collier@kcl.ac.uk   
Northumberland Tyne and Wear NHS Foundation Trust Recruiting
Newcastle Upon Tyne, United Kingdom, SR20NB
Contact: Rajesh Nair, M.D.    0303 123 1145    rajesh.nair@ncl.ac.uk   
Oxford Health NHS Foundation Trust Recruiting
Oxford, United Kingdom, OX42GX
Contact: Belinda Lennox, M.D.    01865618231    belinda.lennox@psych.ox.ac.uk   
Contact: Rebecca Dean    01865 902543    rebecca.dean@oxfordhealth.nhs.uk   
Southern Health NHS Foundation Trust Recruiting
Southampton, United Kingdom, SO140YG
Contact: Shanaya Rathod, M.D.    02380475373    shanayarathod@nhs.net   
Contact: Marek Czeladzki    02380475943    m.czeladzki@nhs.net   
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03568500     History of Changes
Other Study ID Numbers: 031-201-00186
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Digital Medicine System

Additional relevant MeSH terms:
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Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Disease
Schizophrenia
Pathologic Processes
Risperidone
Aripiprazole
Antipsychotic Agents
Olanzapine
Quetiapine Fumarate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Dopamine Agonists
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents