A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder

Study Identifier:
031-201-00181
ClinicalTrials.gov Identifier:
NCT04030143
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
Subscribe to Updates

Results Availables

Study Protocol
Available Language: English
Download document(s)
Statistical Analysis Plan
Available Language: English
Download document(s)

Study Details

Medical Condition
  • Schizophrenia
  • Bipolar Disorder
Study Drug
  • Drug: Aripiprazole
Date
Aug 2019 - Jul 2020
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 64 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • A current diagnosis of schizophrenia or bipolar I disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
  • Body mass index of 18 to 35 kilograms per meter square (kg/m\^2).
  • On a stable dose of an atypical oral antipsychotic medication for at least 2 months prior to screening.
Exclusion Criteria
  • Participants who have:
  • Met DSM-5 criteria for substance use disorder within the past 180 days.
  • A positive drug screen for drugs of abuse
  • Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication; or participants who use more than one antipsychotic or mood stabilizer(s) medication at screening.
  • Females who are pregnant, breast-feeding, lactating, and/or have a positive pregnancy test result prior to receiving investigational medicinal product (IMP). A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female participants.
  • Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
  • Evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations.
  • Participants currently in an acute relapse of schizophrenia.
  • Participants with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder, including schizoaffective disorder, major depressive disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, participants with borderline, paranoid, histrionic, or antisocial personality disorder.
  • Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia.
  • History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
  • History of or current hepatitis or acquired immunodeficiency syndrome or carriers of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (anti-HCV), and/or Human immunodeficiency virus (HIV) antibodies.
  • Participants deemed intolerant of receiving injections.
  • Participants who have had electroconvulsive therapy within 2 months of administration of IMP.

Protocol Summary

The purpose of this trial is to determine the safety and tolerability of multiple-dose administrations of aripiprazole, to establish the similarity of aripiprazole concentrations on the last day of the dosing interval following the final administration of aripiprazole into the gluteal muscle site, and to establish the similarity of aripiprazole exposure over the dosing interval following the administration of aripiprazole into the gluteal muscle site in adult participants with schizophrenia or bipolar I disorder.

Study Locations

Location
Status
Location
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Status
N/A
Location
Woodland International Research Group
Rogers, Arkansas, United States, 72758
Status
N/A
Location
CITrials - Bellflower
Bellflower, California, United States, 90706
Status
N/A
Location
Collaborative Neuroscience Network
Garden Grove, California, United States, 92845
Status
N/A
Location
California Clinical Trials Medical Group
Glendale, California, United States, 91206
Status
N/A
Location
Synergy Research Centers
Lemon Grove, California, United States, 91945
Status
N/A
Go to page
© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • A current diagnosis of schizophrenia or bipolar I disorder, as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
  • Body mass index of 18 to 35 kilograms per meter square (kg/m\^2).
  • On a stable dose of an atypical oral antipsychotic medication for at least 2 months prior to screening.
Exclusion criteria
  • Participants who have:
  • Met DSM-5 criteria for substance use disorder within the past 180 days.
  • A positive drug screen for drugs of abuse
  • Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication; or participants who use more than one antipsychotic or mood stabilizer(s) medication at screening.
  • Females who are pregnant, breast-feeding, lactating, and/or have a positive pregnancy test result prior to receiving investigational medicinal product (IMP). A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female participants.
  • Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
  • Evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations.
  • Participants currently in an acute relapse of schizophrenia.
  • Participants with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder, including schizoaffective disorder, major depressive disorder, delirium, dementia, amnestic, or other cognitive disorders. Also, participants with borderline, paranoid, histrionic, or antisocial personality disorder.
  • Participants with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia.
  • History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
  • History of or current hepatitis or acquired immunodeficiency syndrome or carriers of Hepatitis B surface antigen (HBsAg) or Hepatitis C antibodies (anti-HCV), and/or Human immunodeficiency virus (HIV) antibodies.
  • Participants deemed intolerant of receiving injections.
  • Participants who have had electroconvulsive therapy within 2 months of administration of IMP.

We defy limitation,

so that others can too.

Follow Us
OAPI and OPDC Locations

508 Carnegie Center Dr,

Princeton, NJ 08540, United States

Phone 609-524-6788

2440 Research Blvd,

Rockville, MD 20850, United States

Phone 301-424-9055

3956 Point Eden Way

Hayward, CA 94545, United States

Phone 800-562-3974