Overview

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.