Phase 1
Completed N=41
A Multiple Dose Safety, Tolerability and Pharmacokinetics Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot
Source: ClinicalTrials.gov NCT01870999 ↗Enrolled (actual)
41
Serious AEs
7.7%
Results posted
Jan 2014
Primary outcomePrimary: Number of Participants With Adverse Events as a Measure of Safety — 11; 11; 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events as a Measure of Safety |
11; 11; 6 | — |
| PRIMARY Aripiprazole Maximum Steady State Plasma Concentration (Css,Max) |
316; 269; 100 | — |
| PRIMARY Aripiprazole Minimum Steady State Plasma Concentration (Css,Min) |
212; 156; 95.0 | — |
| PRIMARY Aripiprazole Area Under the Concentration-time Curve at Steady-state (AUCτ) |
163; 140; 54.5 | — |
| SECONDARY Aripiprazole Maximum (Peak) Plasma Concentration (Tmax) |
7.1; 6.5; 5.0 | — |
| SECONDARY Aripiprazole Steady-state Plasma Concentration (Css,Avg) |
242; 208; 81.1 | — |
| SECONDARY Aripiprazole Terminal-phase Elimination Half-life (t1/2,z) |
46.5; 29.9 | — |
| SECONDARY Dehydro-aripiprazole Maximum Steady State Plasma Concentration (Css,Max) |
89.4; 74.7; 30.3 | — |
| SECONDARY Dehydro-aripiprazole Minimum Steady State Plasma Concentration (Css,Min) |
64.1; 54.1; 26.2 | — |
| SECONDARY Dehydro-aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ) |
47.8; 38.9; 14.7 | — |
| SECONDARY Dehydro-aripiprazole Maximum (Peak) Plasma Concentration (Tmax) |
6.6; 12.5; 5.5 | — |
| SECONDARY Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 and Week 24 |
0.0; 1.1; -1.3; -0.8; -1.6; -1.3 | — |
| SECONDARY Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Positive Subscale Scores at Week 12 and Week 24 |
-1.2; 1.3; -1.0; -1.6; 0.4; -1.0 | — |
| SECONDARY Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Negative Subscale Scores at Week 12 and Week 24 |
1.1; 0.1; 0.0; 0.5; -0.1; -0.6 | — |
| SECONDARY Change From Baseline in the Clinical Global Impression- Severity of Illness Score (CGI-S) at Week 12 and Week 24 |
-0.1; 0.0; -0.2; -0.1; -0.1; -0.2 | — |
| SECONDARY Clinical Global Impression-Improvement Scale (CGI-I) at Week 12 and Week 24 |
3.3; 3.6; 3.4; 3.7; 3.4; 3.7 | — |
| SECONDARY Number of Participants Hospitalized for Adverse Event "Worsening Schizophrenia" |
0; 1; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01870999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.