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Trial record 71 of 405 for:    ARIPIPRAZOLE

A Trial to Measure the Difference in All-cause Hospitalizations for Patients Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder

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ClinicalTrials.gov Identifier: NCT03643159
Recruitment Status : Terminated (Difficulty in patient recruitment)
First Posted : August 22, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
A pragmatic clinical trial (Main Study) to assess the difference between all-cause hospitalizations in patients using Abilify MyCite versus virtual matched controls. Eligible patients will enter a screening period of up to 13 days. At enrollment, patients will receive treatment with Abilify MyCite for 3 months and discontinue the use of Abilify MyCite during the following 3 months (and the patient continues with oral aripiprazole or other appropriate treatment). Thereafter, the patient has the option to start and stop Abilify MyCite (up to 6 months of Abilify MyCite) per the joint decision of the patients with their study physician. A parallel exploratory study will utilize a different set of physicians and patients from the main study. Procedures for the exploratory study will be similar to those in the Main Study, with the exception that there will be 1-month intervals of Abilify MyCite use (and 1-month intervals of prohibition of Abilify MyCite use).

Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar I Disorder Major Depressive Disorder Combination Product: Abilify MyCite - Digital Medicine System Drug: aripiprazole or other oral antipsychotics Phase 4

Detailed Description:

This is a phase 4, open-label, prospective, pragmatic clinical trial to assess the difference between all-cause hospitalizations in patients using Abilify MyCite (for Months 1-3, then prohibited for Months 4-6) versus virtual matched controls from baseline to Day 180. Virtual matched controls would be receiving treatment as usual (ie, any product other than Abilify MyCite, which may be oral aripiprazole or any other product). Eligible patients will enter a screening period of up to 13 days. For patients enrolling into the study, those not on aripiprazole at screening will use the screening period for conversion to aripiprazole from other antipsychotics. At the baseline visit, Abilify MyCite onboarding will be provided in the office, then, patients will initiate 3 months of treatment with Abilify MyCite. During the following 3 months (Months 4-6), use of Abilify MyCite will be prohibited (and the patient continues with oral aripiprazole or other appropriate treatment, per routine clinical care).

After the visit at Day 180, a second, optional interventional period (up to 6 months of Abilify MyCite) may be initiated per the joint decision of the patients with their study physician; patients in this second, optional interventional period will have a visit at Day 360. During this second, optional interventional period, patients may start and stop Abilify MyCite as clinically indicated.

In addition, there will be a parallel exploratory study, which will utilize a different set of physicians and patients from the main study. Results from the exploratory study will be analyzed separately from the main study results.

Procedures for the exploratory study will be similar to those in the main study, with the exception that there will be 1-month intervals of Abilify MyCite use (and 1-month intervals of prohibition of Abilify MyCite use). During periods of nonuse of Abilify MyCite, the patient continues with oral aripiprazole treatment, per routine clinical care.

In the exploratory study, each patient will receive Abilify MyCite per 1 one of 2 sequences over a 360-day period: Sequence 1: Only in Months 1, 2, 5, and 10, Sequence 2: Only in Months 1, 4, 7, and 10. Sites will be randomized to 1 of the 2 sequences. For this exploratory study, the site visits will be at screening, baseline, Day 180, and Day 360. The exploratory arm will begin after the main study is enrolled at approximately 50% (ie, staggered start).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Main Study patients receive treatment with Abilify MyCite during Month 1 through Month 3. During Months 4 through 6, use of Abilify MyCite will be prohibited (and the patient continues with oral aripiprazole or other appropriate treatment, per routine clinical care). Thereafter, at Day 180, a second, optional interventional period (up to 6 months of Abilify MyCite) may be initiated per the joint decision of the patients with their study physician.

In the exploratory study, each patient will receive Abilify MyCite per 1 one of the 2 sequences over a 360-day period: Sequence 1: Only in Months 1, 2, 5, and 10; Sequence 2: Only in Months 1, 4, 7, and 10.

Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Multicenter, 180-day Pragmatic Clinical Trial to Measure the Difference in All-cause Hospitalizations for Patients Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder
Actual Study Start Date : June 29, 2018
Actual Primary Completion Date : October 17, 2018
Actual Study Completion Date : October 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Abilify MyCite
Patients will receive Abilify MyCite during Months 1-3. During Months 4-6 use of Abilify MyCite will be prohibited. Thereafter, at Day 180, a second, optional interventional period (up to 6 months of Abilify MyCite) may be initiated per the joint decision of the patients with their study physician. The treatment medication dose decision will be determined by the study physicians independent from the protocol.
Combination Product: Abilify MyCite - Digital Medicine System
The Abilify MyCite system is a drug-device combination product comprised of aripiprazole (an atypical antipsychotic) tablets embedded with a sensor that communicates with a patch (wearable sensor) and a medical software application with collected information (ingestion, mood, activity, rest) tracked and summarized for patients, HCPs, and potentially caregivers. Abilify MyCite is intended to track drug ingestion and is indicated for the treatment of adults with SCH, BP1 (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with MDD.

Drug: aripiprazole or other oral antipsychotics
For the treatment of adults with SCH, BP1 (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with MDD.

Active Comparator: Treatment As Usual
Virtual matched controls will receive treatment as usual (i.e. any product other than Abilify MyCite, which may be oral aripiprazole or any other product) throughout the duration of the trial. The treatment medication dose decision will be determined by the study physicians independent from the protocol.
Drug: aripiprazole or other oral antipsychotics
For the treatment of adults with SCH, BP1 (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with MDD.




Primary Outcome Measures :
  1. All-cause hospitalizations [ Time Frame: up to 180 Days ]
    Difference in proportion of patients with all-cause hospitalizations for patients using Abilify MyCite versus Virtual Matched Controls.


Secondary Outcome Measures :
  1. Proportion of Days Covered [ Time Frame: Up to 180 Days ]
    Difference between groups (Abilify MyCite versus Virtual Matched Controls) in proportion of patients with at least 80% proportion of days covered (PDC) with antipsychotic medication.



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Ages Eligible for Study:   18 Years to 63 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients are actively enrolled in an Anthem-affiliated commercial, Medicaid, or Medicare health plan with medical and pharmacy benefits.
  • Patients must have a smartphone with data plan.
  • Patients currently prescribed aripiprazole, or appropriate for aripiprazole treatment.
  • Patients must have a current diagnosis of SCH, BP1, or MDD.

Exclusion Criteria:

  • Any patient who participated in another clinical trial within 30 days of enrollment into the current study.
  • Females who are breast-feeding and/or who are pregnant at the time of study enrollment, or who plan to become pregnant during the study.
  • Patients who are currently being treated with a long-acting injectable antipsychotic.

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): NCT03643159


Locations
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United States, California
Siyan Clinical Research
Santa Rosa, California, United States, 95401
United States, Georgia
Psychiatric Addiction Curative/PACT Atlanta LLC
Decatur, Georgia, United States, 30030
United States, Nevada
Kolade Research Institute
Las Vegas, Nevada, United States, 89109
United States, Ohio
Signature Research Associates, Inc.
Fairlawn, Ohio, United States, 44333
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03643159     History of Changes
Other Study ID Numbers: 316-13-217
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018

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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

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

Additional relevant MeSH terms:
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Aripiprazole
Disease
Schizophrenia
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Behavioral Symptoms
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antidepressive Agents
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