Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects With Schizophrenia
Status and phase
Conditions
Treatments
Details and patient eligibility
About
To determine the safety and tolerability of multiple-dose administrations of aripiprazole intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia
Full 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 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
141 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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