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

Completed · Phase 1/Phase 2

Conditions studied: Schizophrenia, Bipolar I Disorder

In brief

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.

Key facts

Study ID

NCT04030143

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

266

Starts

2019-08-01

Expected to finish

2020-07-08

Last updated by the study team

2023-11-18

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Woodland International Research Group — Little Rock, Arkansas, United States
• Woodland International Research Group — Rogers, Arkansas, United States
• CITrials - Bellflower — Bellflower, California, United States
• Collaborative Neuroscience Network — Garden Grove, California, United States
• California Clinical Trials Medical Group — Glendale, California, United States
• Synergy Research Centers — Lemon Grove, California, United States
• NRC Research Institute — Orange, California, United States
• California Neuropsychopharmacology Clinical Research Institute San Diego — San Diego, California, United States
• Collaborative Neuroscience Network - South Bay — Torrance, California, United States
• Research Centers of America — Hollywood, Florida, United States
• Segal Institute For Clinical Research - West Broward Outpatient Clinic — Miami Lakes, Florida, United States
• Atlanta Center for Medical Research - Atlanta — Atlanta, Georgia, United States
• CBH Health — Gaithersburg, Maryland, United States
• St. Louis Clinical Trials — St Louis, Missouri, United States
• Altea Research Institute - Las Vegas — Las Vegas, Nevada, United States
• Hassman Research Institute — Marlton, New Jersey, United States
• Midwest Clinical Research Center — Dayton, Ohio, United States
• Carolina Clinical Trials — Charleston, South Carolina, United States
• Community Clinical Research — Austin, Texas, United States

Full record on ClinicalTrials.gov

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