Adherence to Treatment, Safety and Tolerability Study of the Medical Information Device #1 (MIND1) in Subjects With Schizophrenia or Bipolar I Disorder

NCT01981811 | Withdrawn Phase 2

• 1 other identifier: 316-13-211
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 12

Brief Summary

The purpose of this study is to evaluate adherence to treatment with, and safety and tolerability of, the medical information device #1 (MIND1) system in subjects with Schizophrenia or Bipolar I Disorder who are currently treated with oral aripiprazole.

Conditions

Bipolar 1 Disorder; 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)

• Medication adherence, as defined by the number of IEM detections reported by the MIND1 System divided by the medication doses prescribed.

  Baseline to Week 12

Secondary Outcomes (1)

• Compliance, defined as the ratio of individual model-predicted exposure (AUC) at Week 12 following administration of oral aripiprazole using the MIND1 System versus the expected exposure

  Week 12

Other Outcomes (5)

• Comparison of the predicted PK exposure (log transformed-area under the plasma concentration-time curve [AUC]) at Week 12 to the predicted PK exposure prior to use of the MIND1 System

  Week 12

• Change in compliance, defined as the difference in predicted adherence at Week 12 and the predicted adherence before using the MIND1 System

  Week 12

• Proportion of subjects who achieve greater than 80% compliance post-Week 12 administration of aripiprazole through MIND1

  Baseline to Week 12

Study Arms (1)

Aripiprazole and Ingestible Event Marker (IEM)

ACTIVE COMPARATOR

All subjects will continue to receive their previously prescribed dose of aripiprazole (10 mg, 15 mg, 20 mg, or 30 mg) through the trial. Subjects will discontinue dosing of the conventional oral aripiprazole tablet and will begin taking MIND1 (aripiprazole embedded with an Ingestible Event Marker) tablet once-daily for 12 weeks.

Drug: Aripiprazole; Device: Ingestible Event Marker (IEM)

Interventions

Aripiprazole DRUG

Aripiprazole and Ingestible Event Marker (IEM)

Ingestible Event Marker (IEM) DEVICE

Aripiprazole and Ingestible Event Marker (IEM)

Eligibility Criteria

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

You may qualify if:

• Males and females 18 to 65 years of age, inclusive, at time of informed consent
• Schizophrenia: Patients with two or more exacerbations of symptoms in past year leading to an intervention, per investigator's judgment (ie, inpatient psychiatric hospitalization, psychiatric ER visit, admission to partial hospitalization program, crisis residential treatment, etc.). This does not include outpatient adjustment of medication.
• Bipolar I Disorder: Patients with at least one manic episode or exacerbation of bipolar symptoms in past year resulting in an intervention, per Investigator's judgment (i.e., inpatient psychiatric hospitalization, psychiatric ER visit, admission to partial hospitalization program, crisis residential treatment, etc.) This does not include outpatient adjustment of medication.
• Current primary Axis-1 diagnosis of bipolar 1 disorder or schizophrenia as defined by DSM-IV-TR criteria
• Bipolar 1 disorder patients with a total YMRS score of 10 to 25 (inclusive)
• Schizophrenia patients with a total PANSS score of 60 to 90 (inclusive)
• Currently prescribed oral Aripiprazole for either bipolar 1 disorder or schizophrenia. No changes in their Aripiprazole dose or regimen 2 weeks before screening.
• Subjects must be able to tolerate blood draws.
• If subject is on other psychotropic medications, he/she must be on a stable dose and regimen over the last 2 weeks.

You may not qualify if:

• Subjects with a current Axis I (DSM-IV-TR) diagnosis other than bipolar 1 disorder or schizophrenia
• Subjects with a current Axis II (DSM-IV-TR) diagnosis
• History of inpatient hospitalization for any psychiatric reason within 2 months before screening
• Subjects who reside or attend a facility where medication is administered to them
• Subject has received any investigational product within the last 30 days
• Allergic, intolerant, or unresponsive to prior treatment with Aripiprazole or other quinolinones
• History of hypersensitivity to antipsychotic agents

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (12)

Unknown Facility

Cerritos, California, 90703, United States

Location

Unknown Facility

Garden Grove, California, 92845, United States

Location

Unknown Facility

Long Beach, California, 90813, United States

Location

Unknown Facility

National City, California, 91950, United States

Location

Unknown Facility

Oceanside, California, 92056, United States

Location

Unknown Facility

San Diego, California, 92123, United States

Location

Unknown Facility

Washington D.C., District of Columbia, 20016, United States

Location

Unknown Facility

Atlanta, Georgia, 30308, United States

Location

Unknown Facility

St Louis, Missouri, 63118, United States

Location

Unknown Facility

Marlton, New Jersey, 08053, United States

Location

Unknown Facility

Dayton, Ohio, 45417, United States

Location

Unknown Facility

Irving, Texas, 75062, United States

Location

MeSH Terms

Conditions

Schizophrenia; Mental Disorders; Nervous System Diseases; Treatment Adherence and Compliance

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Shashank Rohatagi, PhD

  Otsuka Pharmaceutical Development & Commercialization, Inc.

  STUDY DIRECTOR

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: October 22, 2013
• First Posted: November 13, 2013
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

US (12)