Clinical trial NCT01870999: A Multiple Dose Safety, Tolerability and Pharmacokinetics Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot
Official title: An Open-label Parallel Arm Multiple Dose Tolerability, Pharmacokinetics and Safety Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot Formulation Once Every Four Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety
timeFrame: 7 Months
measure: Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
timeFrame: Pre-dose and 1 to 1344 hours post-dose at Month 5
measure: Aripiprazole Minimum Steady State Plasma Concentration (Css,Min)
timeFrame: 672 hours post-dose at Month 5
measure: Aripiprazole Area Under the Concentration-time Curve at Steady-state (AUCτ)
timeFrame: Pre-dose and 1 to 1344 hours post-dose at Month 5
Secondary outcomes:
measure: Aripiprazole Maximum (Peak) Plasma Concentration (Tmax)
timeFrame: Pre-dose and 1 to 1344 hours post-dose at Month 5
measure: Aripiprazole Steady-state Plasma Concentration (Css,Avg)
timeFrame: Pre-dose and 1 to 1344 hours post-dose at Month 5
measure: Aripiprazole Terminal-phase Elimination Half-life (t1/2,z)
timeFrame: Pre-dose and 1 to 1344 hours post-dose at Month 5
measure: Dehydro-aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
timeFrame: Pre-dose and 1 to 1344 hours post-dose at Month 5
measure: Dehydro-aripiprazole Minimum Steady State Plasma Concentration (Css,Min)
timeFrame: Pre-dose and 1 to 1344 hours post-dose at Month 5
measure: Dehydro-aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ)
timeFrame: Pre-dose and 1 to 1344 hours post-dose at Month 5
measure: Dehydro-aripiprazole Maximum (Peak) Plasma Concentration (Tmax)
timeFrame: Pre-dose and 1 to 1344 hours post-dose at Month 5
measure: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 and Week 24
timeFrame: Baseline, Week 12, Week 24
measure: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Positive Subscale Scores at Week 12 and Week 24
timeFrame: Baseline, Week 12, Week 24
measure: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Subscale Scores at Week 12 and Week 24
timeFrame: Baseline, Week 12, Week 24
measure: Change From Baseline in the Clinical Global Impression- Severity of Illness Score (CGI-S) at Week 12 and Week 24
timeFrame: Baseline, Week 12, Week 24
measure: Clinical Global Impression-Improvement Scale (CGI-I) at Week 12 and Week 24
timeFrame: Baseline, Week 12, Week 24
measure: Number of Participants Hospitalized for Adverse Event "Worsening Schizophrenia"
timeFrame: 7 Months
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: Otsuka Investigative Site
state: California
city: Garden Grove
country: United States
facility: Otsuka Investigative Site
state: California
city: Glendale
country: United States
facility: Otsuka Investigative Site
state: California
city: Paramount
country: United States
facility: Otsuka Investigative Site
state: California
city: St. Louis
country: United States
facility: Otsuka Investigative Site
state: Missouri
city: Willingboro
country: United States
facility: Otsuka Investigative Site
state: New Jersey
city: Austin
country: United States
facility: Otsuka Investigative Site
state: Texas
Study officials:
References: