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

NCT ID: NCT04030143

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-01
• Study Completion Date: 2020-07-08

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 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.

Conditions

Schizophrenia; Bipolar I Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Aripiprazole 2M LAI 960 mg: Schizophrenia or Bipolar I Disorder

Participants with schizophrenia or bipolar I disorder received aripiprazole 2 month (2M) long-acting injection (LAI) 960 milligrams (mg) for a total of 4 injections administered every 56 days (± 2 days) over the course of 32 weeks.

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Administered as an intramuscular (IM) depot injection.

Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder

Participants with schizophrenia or bipolar I disorder received aripiprazole IM 400 mg, for a total of 8 injections administered every 28 days (± 2 days) over the course of 32 weeks.

Group Type: EXPERIMENTAL

Aripiprazole

Intervention Type: DRUG

Administered as an IM depot injection.

Interventions

Aripiprazole

Administered as an intramuscular (IM) depot injection.

Intervention Type: DRUG

Aripiprazole

Administered as an IM depot injection.

Intervention Type: DRUG

Other Intervention Names

OPC-14597; Lu AF41155; OPC-14597; Lu AF41155

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

References

Citrome L, Such P, Yildirim M, Madera-McDonough J, Beckham C, Zhang Z, Larsen F, Harlin M. Safety and Efficacy of Aripiprazole 2-Month Ready-to-Use 960 mg: Secondary Analysis of Outcomes in Adult Patients With Schizophrenia in a Randomized, Open-label, Parallel-Arm, Pivotal Study. J Clin Psychiatry. 2023 Sep 4;84(5):23m14873. doi: 10.4088/JCP.23m14873.

Reference Type: DERIVED

PMID: 37672016 (View on PubMed)

McIntyre RS, Such P, Yildirim M, Madera-McDonough J, Zhang Z, Larsen F, Harlin M. Safety and efficacy of aripiprazole 2-month ready-to-use 960 mg: secondary analysis of outcomes in adult patients with bipolar I disorder in a randomized, open-label, parallel-arm, pivotal study. Curr Med Res Opin. 2023 Jul;39(7):1021-1030. doi: 10.1080/03007995.2023.2219155. Epub 2023 Jun 9.

Reference Type: DERIVED

PMID: 37272079 (View on PubMed)

Harlin M, Yildirim M, Such P, Madera-McDonough J, Jan M, Jin N, Watkin S, Larsen F. A Randomized, Open-Label, Multiple-Dose, Parallel-Arm, Pivotal Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole 2-Month Long-Acting Injectable in Adults With Schizophrenia or Bipolar I Disorder. CNS Drugs. 2023 Apr;37(4):337-350. doi: 10.1007/s40263-023-00996-8. Epub 2023 Mar 24.

Reference Type: DERIVED

PMID: 36961650 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

031-201-00181

Identifier Type: -

Identifier Source: org_study_id