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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborator: H. Lundbeck A/S
• Treatments: Aripiprazole

Criteria

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.