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

Schizophrenia Clinical Trial

Official title:

A Single-arm Study 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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01981811
• Other study ID #: 316-13-211
• Status: Withdrawn
• Phase: Phase 2
• First received: October 22, 2013
• Last updated: April 27, 2015
• Start date: March 2014
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Poor adherence to medication is a well-recognized problem in psychiatric patients and is a barrier to achieving optimal health. The MIND1 System is being developed to objectively and precisely monitor and measure real-time medication adherence; and to potentially enhance adherence. The MIND1 System includes oral aripiprazole with an embedded ingestible event marker (IEM), a Wearable Sensor, and a computerized device and accessories. This is a trial designed 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. This 12-week, single-arm trial will include male and female subjects 18 to 65years (inclusive) with a current diagnosis of schizophrenia or bipolar I disorder who are currently treated with oral aripiprazole.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar 1 Disorder
• Disease
• Mental Disorder
• Mental Disorders
• Nervous System Diseases
• Psychotic Disorders
• Schizophrenia

Intervention

Drug:
• Aripiprazole

Device:
• Ingestible Event Marker (IEM)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Change in compliance, defined as the difference in predicted adherence at Week 12 and the predicted adherence before using the MIND1 System		Week 12	No
Other	Proportion of subjects who achieve greater than 80% compliance post-Week 12 administration of aripiprazole through MIND1		Baseline to Week 12	No
Other	Severity of illness, defined by the change from Screening/baseline to Week 12 with scores on the CGI-scale, PSP, SLOF, PANSS and YMRS.		Screening/baseline to Week 12	No
Other	Safety and tolerability: frequency and severity of AEs; frequency of serious AEs; AEs leading to discontinuation; and frequency and severity of unexpected adverse events and unanticipated device adverse events (UDAE)		Baseline to Week 12	Yes
Primary	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	No
Secondary	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	No