Status:
COMPLETED
Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects With Schizophrenia
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
H. Lundbeck A/S
Conditions:
Schizophrenia
Mental Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief 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
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT01909466
Start Date
July 1 2013
End Date
April 1 2014
Last Update
July 1 2015
Active Locations (11)
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1
Comprehensive Clinical Development
Cerritos, California, United States, 90703
2
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States, 92845
3
CNRI-San Diego
San Diego, California, United States, 92101
4
Comprehensive Clinical Development
Washington D.C., District of Columbia, United States, 20016