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

NCT02050854 | Completed

• 1 other identifier: 316-13-212
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 5

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.

Conditions

Bipolar 1 Disorder; Schizophrenia; Mental Disorder; Nervous System Disorders

Keywords

Aripiprazole; Treatment Adherence

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (1)

Observation

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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)

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
• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (5)

Unknown Facility

Garden Grove, California, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Decatur, Georgia, United States

Location

Unknown Facility

Rockville, Maryland, United States

Location

Unknown Facility

Bellevue, Washington, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, Plasma

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Health Behavior; Behavior

Study Officials

• Kimberly Largay, MD

  Otsuka Pharmaceutical Development & Commercialization, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 31, 2014
• Study Start: December 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 31, 2014

Record last verified: 2014-01

Locations

US (5)