Status:
COMPLETED
A Trial of Multiple-doses of Aripiprazole in Adults With Schizophrenia or Bipolar 1 Disorder
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions:
Schizophrenia
Bipolar I Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
PHASE2
Brief 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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2020
Estimated Enrollment :
266 Patients enrolled
Trial Details
Trial ID
NCT04030143
Start Date
August 1 2019
End Date
July 8 2020
Last Update
November 18 2023
Active Locations (19)
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1
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
2
Woodland International Research Group
Rogers, Arkansas, United States, 72758
3
CITrials - Bellflower
Bellflower, California, United States, 90706
4
Collaborative Neuroscience Network
Garden Grove, California, United States, 92845