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

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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.
We found this trial at
3
sites
Austin, Texas 78754
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San Diego, California 92101
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Washington, District of Columbia 20016
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Washington,
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