Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects With Schizophrenia

An Open-label, Multiple Dose, Safety and Tolerability Study of Aripiprazole IM Depot Administered in the Deltoid Muscle in Adult Subjects With Schizophrenia

To determine the safety and tolerability of multiple-dose administrations of aripiprazole intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia

This is a trial designed to assess the safety and tolerability of multiple-dose administrations of aripiprazole intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia. The trial consists of a 113 day treatment period with a 28 day followup. The trial population will include male and female subjects between 18 and 64 years (inclusive), with a current diagnosis of schizophrenia as defined by DSM-IV-TR criteria and a prior history of tolerating aripiprazole per investigator's judgement.

Inclusion Criteria:

• Male and female individuals between 18 and 64 years, inclusive, at the time of informed consent.
• Prior history of tolerating aripiprazole per investigator's judgement.

Exclusion Criteria:

• Subjects who have met DSMV-IV-TR criteria for substance dependence within the past 180 days.
• Subjects who use more than one antipsychotic medication at screening.
• Use of any CYP2D6 and CYP3A4 inhibitors, or CYP3A4 inducers within 14 days prior to dosing and for the duration of the trial.
• Subjects who participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment.
• Subjects currently in an acute relapse of schizophrenia.
• Subjects with a current DSMV-IV-TR diagnosis other than schizophrenia.
• Subjects who are considered treatment-resistant to antipsychotic medications.