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A Trial in Adult Subjects With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®

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ClinicalTrials.gov Identifier: NCT03892889
Recruitment Status : Not yet recruiting
First Posted : March 27, 2019
Last Update Posted : March 27, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
To compare inpatient psychiatric hospitalization rates while subjects are on oral standard-of-care antipsychotic treatment and later switched to Abilify MyCite. This trial will include male and female subjects who are 18 to 65 years old and diagnosed with schizophrenia. The trial will be conducted at 75 sites in the United States, with the a target of enrolling 320 subjects. Subject participation is approximately 8 months, including a 45-day screening period, a required 3 months (Months 1 to 3) of Abilify MyCite treatment. This will be followed to either a change back to standard-of-care antipsychotic treatment or remain on Abilify MyCite for an additional 3 months (Months 4-6). All subjects who complete or withdraw from the trial while on Abilify MyCite will receive a telephone call for safety follow-up approximately 30 days after their last trial visit.

Condition or disease Intervention/treatment Phase
Schizophrenia Combination Product: ABILIFY MYCITE Phase 3

Detailed Description:
This is a phase 3b, open-label, prospective, clinical trial designed to assess the difference between inpatient psychiatric hospitalization rates in subjects on oral standard-of-care antipsychotic treatment(s) for a period of 6 months followed by a switch to Abilify MyCite for a period of 3 months (Months 1 to 3). At the Month 3 visit, the investigator should decide if subjects will continue on Abilify MyCite for an additional 3 months (Months 4 to 6) or switch to a standard-of-care treatment for the duration of treatment. This trial will include male and female subjects who are 18 to 65 years of age, inclusive, with a diagnosis of schizophrenia. Subjects must have had at least 1 inpatient psychiatric hospitalization within 4 years (48 months) and must have been prescribed oral antipsychotics for at least 6 months or longer prior to screening. Subjects will enter a screening period (up to 45 days). If deemed eligible to participate, subjects will enter an open-label Abilify MyCite treatment prospective phase for up to 6 months. All subjects who complete or withdraw from the trial while on Abilify MyCite will receive a telephone call for safety follow-up approximately 30 days after their last trial visit. The trial will be conducted at 75 sites in the United States, 493 subjects will be screened in order to enroll 320 subjects and complete 224 subjects.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Phase IIIb Multi-Center, Open-Label, Mirror-Image, Trial in Adult Subjects With Schizophrenia Treated Prospectively for 6-months With Abilify MyCite®
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: ABILIFY MYCITE
Subjects will receive Abilify MyCite for 3 months (Months 1 to 3) and at the Month 3 visit, the investigator should decide if subjects will continue on Abilify MyCite for an additional 3 months (Months 4 to 6) or switch to a standard-of-care treatment (eg, oral atypical antipsychotics or a long acting injectable [LAI]) for the duration of treatment.
Combination Product: ABILIFY MYCITE
Abilify MyCite tracks drug ingestion and is composed of an Aripiprazole tablet embedded with a sensor (Abilify MyCite). Abilify MyCite Patch (wearable) detects the signal from the sensor after ingestion and transmits data to a smartphone. Abilify MyCite App, a smartphone app, which is used with a compatible smartphone to display medication ingestion information for the subject. Web-based portal or dashboard for investigators and caregivers.




Primary Outcome Measures :
  1. Inpatient psychiatric hospitalization [ Time Frame: 3 months ]
    Comparison of inpatient psychiatric hospitalization rates of subjects on oral standard-of-care antipsychotic treatment and switching to Abilify MyCite.


Secondary Outcome Measures :
  1. Improved adherence based on overall proportion of days covered with Abilify MyCite versus retrospective oral atypical antipsychotics. [ Time Frame: Retrospective - Months 1-3 and Prospective - Months 1-3 ]


Information from the National Library of Medicine

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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 must be willing and able to give written informed consent, adhere to trial procedures and able to read and understand English.
  • Male and female subjects 18 to 65 years of age
  • Subject must possess a smartphone and is familiar with its use and is willing to download and interact with the Abilify MyCite app. A subject with a smartphone that is not compatible with the Abilify MyCite app will be offered a loaner phone for the trial period.
  • Clinical diagnosis of schizophrenia and able to ingest oral medication
  • Positive and Negative Syndrome Scale (PANSS) total score between 60-90.
  • Subjects currently prescribed oral atypical antipsychotic medication including aripiprazole or appropriate for aripiprazole treatment for 6 months or longer.
  • Subjects are required to have had an inpatient hospitalization for schizophrenia within the last 48 months prior to entering the trial.
  • Skin on the anterior chest just above the lower edge of the rib cage that is free of any dermatological problems

Exclusion Criteria:

  • Females who are breast-feeding and/or who are pregnant
  • Sexually active males or women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of Abilify MyCite.
  • Any subject who participated in another clinical trial within 30 days of enrollment
  • Subjects who are currently being treated with an LAI antipsychotic or have been treated with an LAI in the retrospective 6-month phase.
  • Subjects with a current DSM-5 diagnosis other than schizophrenia
  • Subject with a known allergy to adhesive tape or any pertinent components of the patch or aripiprazole tablet embedded with an IEM sensor

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): NCT03892889


Contacts
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Contact: Project Manager 617-460-3028 monarchstudy@iqvia.com

Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03892889     History of Changes
Other Study ID Numbers: 031-201-00301
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 27, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Aripiprazole
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists