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

NCT ID: NCT01870999

Last Updated: 2014-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-10-31

Brief Summary

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.

Conditions

Schizophrenia

Study Design

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

Study Groups

400 mg Aripiprazole IM Depot

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.

Group Type: EXPERIMENTAL

aripiprazole IM depot

Intervention Type: DRUG

Aripiprazole IM depot supplied as 200 mg or 400 mg vials of lyophilized aripiprazole powder to prepare for IM injection.

aripiprazole tablets

Intervention Type: DRUG

Aripiprazole tablets 10 mg once daily in the morning for 14 days.

300 mg Aripiprazole IM Depot

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.

Group Type: EXPERIMENTAL

aripiprazole IM depot

Intervention Type: DRUG

Aripiprazole IM depot supplied as 200 mg or 400 mg vials of lyophilized aripiprazole powder to prepare for IM injection.

aripiprazole tablets

Intervention Type: DRUG

Aripiprazole tablets 10 mg once daily in the morning for 14 days.

200 mg Aripiprazole IM depot

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.

Group Type: EXPERIMENTAL

aripiprazole IM depot

Intervention Type: DRUG

Aripiprazole IM depot supplied as 200 mg or 400 mg vials of lyophilized aripiprazole powder to prepare for IM injection.

aripiprazole tablets

Intervention Type: DRUG

Aripiprazole tablets 10 mg once daily in the morning for 14 days.

Interventions

aripiprazole IM depot

Aripiprazole IM depot supplied as 200 mg or 400 mg vials of lyophilized aripiprazole powder to prepare for IM injection.

Intervention Type: DRUG

aripiprazole tablets

Aripiprazole tablets 10 mg once daily in the morning for 14 days.

Intervention Type: DRUG

Eligibility Criteria

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

• 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

Otsuka Investigative Site

Cerritos, California, United States

Otsuka Investigative Site

Garden Grove, California, United States

Otsuka Investigative Site

Glendale, California, United States

Otsuka Investigative Site

Paramount, California, United States

Otsuka Investigative Site

St Louis, Missouri, United States

Otsuka Investigative Site

Willingboro, New Jersey, United States

Otsuka Investigative Site

Austin, Texas, United States

Countries

United States

Other Identifiers

31-05-244

Identifier Type: -

Identifier Source: org_study_id