A Multiple Dose Safety, Tolerability and Pharmacokinetics Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot

Otsuka

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: aripiprazole tablets; Drug: aripiprazole IM depot

Study type: Interventional

Funder types: Industry

Identifiers

NCT01870999

31-05-244

Details and patient eligibility

About

This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with schizophrenia.

Enrollment: 41 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria
• good physical health as determined by normal medical history, clinical laboratory results, electrocardiograms (ECGs) and physical examinations
• ability to provide informed consent and/or consent from a legally acceptable representation
• body mass index (BMI) of 18 to 35 kg/m^2

Exclusion criteria

• sexually active males and females of child-bearing potential who are not practicing double barrier birth control or are not abstinent during the study plus 30 days for female or 90 days for males following the last dose of medication
• history of drug or alcohol abuse within 6 months and/or positive urine drug screen
• participants who consume alcohol beverages routinely
• participants who consume alcohol beverages during the screening period
• use of any antipsychotic medication, other prohibited psychotropic medication, and any cytochrome P450 2D6 (CYP2D6) and cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 inducers within 14 days
• use of any prescription medication unless approved by Medical Monitor or Study Director
• history of current hepatitis or carrier of HBsAg (Hepatitis B surface antigen) and/or Hepatitis C Virus antibodies (anti-HCV)
• females who are pregnant or lactating
• participants who have participated in any clinical trial involving a psychotropic medication within one month prior to enrollment; participants who have participated in a previous IM Depot study within the last 1 year; patients who have previously enrolled and received study medication in an aripiprazole IM Depot clinical trial
• donation of blood or plasma to a blood bank or in a clinical study (except a screening visit)within 30 days prior to enrollment
• any major surgery within 30 days prior to enrollment
• blood transfusion within 30 days prior to enrollment
• evidence of organ dysfunction or any clinically significant deviation from normal in the physical, electrocardiographic, or clinical laboratory examinations
• patient represents a significant risk of committing suicide based on history
• patients currently in an acute relapse
• patients with Axis I (DSM-IV) diagnosis of schizoaffective or bipolar disorder
• patients who are considered treatment-resistant to antipsychotic medication
• patients with a history of neuroleptic malignant syndrome
• any other sound medical reason as determined by the clinical investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

400 mg Aripiprazole IM Depot

Experimental group

Description:

400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.

Treatment:

Drug: aripiprazole IM depot

Drug: aripiprazole tablets

300 mg Aripiprazole IM Depot

Experimental group

Description:

300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.

Treatment:

Drug: aripiprazole IM depot

Drug: aripiprazole tablets

200 mg Aripiprazole IM depot

Experimental group

Description:

200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.

Treatment:

Drug: aripiprazole IM depot

Drug: aripiprazole tablets