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

Otsuka

Status and phase: Completed; Phase 2; Phase 1

Conditions: Bipolar I Disorder; Schizophrenia

Treatments: Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT04030143

031-201-00181

Details and patient eligibility

About

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.

Enrollment: 266 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

266 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: Aripiprazole

Drug: Aripiprazole

Aripiprazole IM Depot 400 mg: Schizophrenia or Bipolar I Disorder

Experimental group

Description:

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.

Treatment:

Drug: Aripiprazole

Drug: Aripiprazole