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

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ClinicalTrials.gov Identifier: NCT02050854
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : January 31, 2014
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Tracking Information
First Submitted Date January 15, 2014
First Posted Date January 31, 2014
Last Update Posted Date January 31, 2014
Study Start Date December 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2014)
Mean log transformed-area under the plasma concentration-time curve (AUC) at Visit 1 for subjects receiving oral aripiprazole, compared to historical values [ Time Frame: Visit 1 (Day 1) ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 29, 2014)
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 [ Time Frame: Visit 1 (Day 1) to End of Study ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Open-Label Observational Pilot Study to Evaluate the Pharmacokinetics of Aripiprazole in Subjects With Bipolar 1 Disorder or Schizophrenia
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
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood, Plasma
Sampling Method Non-Probability Sample
Study Population Primary care clinic
Condition
  • Bipolar 1 Disorder
  • Schizophrenia
  • Mental Disorder
  • Nervous System Disorders
Intervention Not Provided
Study Groups/Cohorts Observation
Subjects with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal adherence and are currently on treatment with oral aripiprazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 29, 2014)
47
Original Actual Enrollment Same as current
Actual Study Completion Date January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02050854
Other Study ID Numbers 316-13-212
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators Not Provided
Investigators
Study Director: Kimberly Largay, MD Otsuka Pharmaceutical Development & Commercialization, Inc.
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date January 2014