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

Completed · Phase 1

Conditions studied: Schizophrenia, Mental Disorder, Nervous System Diseases

In brief

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

Key facts

Study ID

NCT01909466

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

141

Starts

2013-07-01

Expected to finish

2014-04-01

Last updated by the study team

2015-07-01

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Comprehensive Clinical Development — Cerritos, California, United States
• Collaborative Neuroscience Network, Inc. — Garden Grove, California, United States
• CNRI-San Diego — San Diego, California, United States
• Comprehensive Clinical Development — Washington D.C., District of Columbia, United States
• Scientific Clinical Research, Inc. — Fort Lauderdale, Florida, United States
• Compass Research North, LLC — Leesburg, Florida, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• St. Louis Clinical Trials — St Louis, Missouri, United States
• CRI Lifetree — Marlton, New Jersey, United States
• CRI Lifetree — Philadelphia, Pennsylvania, United States
• Community Clinical Research, Inc. — Austin, Texas, United States

Full record on ClinicalTrials.gov

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