Open-Label Observational Pilot Study to Evaluate the Pharmacokinetics of Aripiprazole in Subjects With Bipolar 1 Disorder or Schizophrenia

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02050854
• Collaborator: (none)
• Enrollment: 47
• Locations: 5
• Duration (Months): 1
• Patients Per Site: 9.4
• Patients Per Site Per Month: 9.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics of aripiprazole in subjects with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal aderence and are currently on treatment with oral aripiprazole.

Condition or Disease	Intervention/Treatment	Phase
Bipolar 1 Disorder; Schizophrenia; Mental Disorder; Nervous System Disorders

Detailed Description

The purpose of this study is to evaluate the pharmacokinetics of aripiprazole in subjects with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal aderence and are currently on treatment with oral aripiprazole. This will be an open-label observational pilot trial to compare the PK profile of aripiprazole at Visit 1 of subjects who are receiving oral aripiprazole and who have the potential for suboptimal adherent behavior with their assigned medication.

Information obtained in the current trial will be used to inform the conduct of a randomized, open-label, parallel-group trial to assess between-group change from baseline adherence using PK sampling in subjects receiving oral aripiprazole with or without the MIND1 System (Protocol 316-13-211).

Study Design

• Study Type: Observational
• Actual Enrollment: 47 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: An Open-Label Observational Pilot Study to Evaluate the Pharmacokinetics of Aripiprazole in Subjects With Bipolar 1 Disorder or Schizophrenia Who Have a History of Suboptimal Adherence and Are Currently on Treatment With Oral Aripiprazole
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Observation Subjects with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal adherence and are currently on treatment with oral aripiprazole

Outcome Measures

Primary Outcome Measures

1. Mean log transformed-area under the plasma concentration-time curve (AUC) at Visit 1 for subjects receiving oral aripiprazole, compared to historical values [Visit 1 (Day 1)]

Secondary Outcome Measures

1. Potential relationships between a clinically accepted indicator of non-adherent behavior, the Morisky 8-item Medication Adherence scale (MMAS-8), and aripiprazole concentrations in subjects [Visit 1 (Day 1) to End of Study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male and female subjects 18 to 55 years of age (inclusive) at time of informed consent

• Subjects with a primary current Axis 1 disorder of bipolar 1 disorder or schizophrenia as defined by DSM-IV-TR criteria, who have been treated in the outpatient setting for at least 2 months before screening

• Subjects with a score of 1-7 on the Morisky 8-Item Medication Adherence Scale (MMAS-8)

• Subjects with bipolar 1 disorder who have a YMRS score of 10 to 25 (inclusive), or subjects with schizophrenia who have a PANSS score of 60 to 90 (inclusive)

• Subjects able to ingest oral medication

• Subjects currently prescribed oral aripiprazole for either bipolar 1 disorder or schizophrenia, and who have not had any changes in their Aripiprazole regimen or dose over the last 2 weeks

• Subjects who have an exacerbation of mood or psychotic symptoms when they are not receiving treatment or are noncompliant with treatment for their bipolar 1 disorder or schizophrenia

• For subjects enrolled with bipolar 1 disorder, the current bipolar episode is mixed or manic (the current must not be a depressive episode)

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

• Subjects not able to self-administer their medication

• Subjects who reside in or attend a facility where medication is administered to them

• Subjects who have a score of 0 or 8 on the Morisky 8-Item Medication Adherence Scale (MMAS-8)

• Subjects who currently meet DSM-IV-TR criteria for substance dependence

• Subjects with a history of inpatient hospitalization for any psychiatric reason within the past 2 months before screening

• Subjects who have received any investigational product within the last 30 days

• Subjects known to be allergic, intolerant, or unresponsive to prior treatment with Aripiprazole or other quinolinones

• Subjects who, per investigator's judgment, are acutely psychotic or manic and/or exhibit symptoms currently requiring hospitalization

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Garden Grove	California	United States
2		Atlanta	Georgia	United States
3		Decatur	Georgia	United States
4		Rockville	Maryland	United States
5		Bellevue	Washington	United States

Sponsors and Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

• Study Director: Kimberly Largay, MD, Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
• ClinicalTrials.gov Identifier: NCT02050854
• Other Study ID Numbers: 316-13-212
• First Posted: Jan 31, 2014
• Last Update Posted: Jan 31, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.: Aripiprazole; Treatment Adherence
• Additional relevant MeSH terms: Nervous System Diseases; Disease; Schizophrenia; Mental Disorders

Study Results

No Results Posted as of Jan 31, 2014