Recruitment

Recruitment Status
Completed
Estimated Enrollment
126

Inclusion Criterias

Prior history of tolerating aripiprazole per investigator's judgement.
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.
Male and female individuals between 18 and 64 years, inclusive, at the time of informed consent.

Exclusion Criterias

Subjects with a current DSMV-IV-TR diagnosis other than schizophrenia.
Subjects who have met DSMV-IV-TR criteria for substance dependence within the past 180 days.
Subjects who participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment.
...
Subjects with a current DSMV-IV-TR diagnosis other than schizophrenia.
Subjects who have met DSMV-IV-TR criteria for substance dependence within the past 180 days.
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 who are considered treatment-resistant to antipsychotic medications.
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 use more than one antipsychotic medication at screening.

Summary

Conditions
  • Mental Disorder
  • Nervous System Diseases
  • Schizophrenia
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 64 years
Gender
Both males and females

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 incl...

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 Criterias

Prior history of tolerating aripiprazole per investigator's judgement.
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.
Male and female individuals between 18 and 64 years, inclusive, at the time of informed consent.

Exclusion Criterias

Subjects with a current DSMV-IV-TR diagnosis other than schizophrenia.
Subjects who have met DSMV-IV-TR criteria for substance dependence within the past 180 days.
Subjects who participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment.
...
Subjects with a current DSMV-IV-TR diagnosis other than schizophrenia.
Subjects who have met DSMV-IV-TR criteria for substance dependence within the past 180 days.
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 who are considered treatment-resistant to antipsychotic medications.
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 use more than one antipsychotic medication at screening.

Locations

Austin, Texas, 78754
Cerritos, California, 90703
Garden Grove, California, 92845
Marlton, New Jersey, 08053
St. Louis, Missouri, 63118
...
Austin, Texas, 78754
Cerritos, California, 90703
Garden Grove, California, 92845
Marlton, New Jersey, 08053
St. Louis, Missouri, 63118
Washington, District of Columbia, 20016
Leesburg, Florida, 34748
San Diego, California, 92101
Ft. Lauderdale, Florida, 33308
Atlanta, Georgia, 30308
Philadelphia, Pennsylvania, 19139

Tracking Information

NCT #
NCT01909466
Collaborators
H. Lundbeck A/S
Investigators
Study Director: Kimberly Largay, MD Otsuka Pharmaceutical Development & Commercialization, Inc.