Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects With Schizophrenia
Status: | Completed |
---|---|
Conditions: | Schizophrenia, Neurology, Psychiatric, Psychiatric |
Therapuetic Areas: | Neurology, Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 64 |
Updated: | 10/19/2013 |
Start Date: | July 2013 |
End Date: | September 2014 |
Contact: | Liz Ferrell |
Email: | eferrell@incresearch.com |
Phone: | 919-334-3554 |
An Open-label, Multiple Dose, Safety and Tolerability Study of Aripiprazole IM Depot Administered in the Deltoid Muscle in Adult Subjects With Schizophrenia
To determine the safety and tolerability of multiple-dose administrations of aripiprazole
intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia
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.
Inclusion Criteria:
- Male and femlae 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 DMSV-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 relaps of schizophreniz.
- Subjects with a current DSMV-IV-TR diagnosis other than schizophrenia.
- Subjects who are considered treatment-resistant to antipsychotic medications.
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