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Safety and Tolerability Study of Aripiprazole IM Depot in Adult Subjects With Schizophrenia

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Otsuka

Status and phase

Completed
Phase 1

Conditions

Mental Disorder
Schizophrenia
Nervous System Diseases

Treatments

Drug: Aripiprazole, OPC-14597

Study type

Interventional

Funder types

Industry

Identifiers

NCT01909466
31-12-298

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

141 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy 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

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

141 participants in 2 patient groups

Gluteal Injection
Other group
Treatment:
Drug: Aripiprazole, OPC-14597
Deltoid Injection
Other group
Treatment:
Drug: Aripiprazole, OPC-14597

Trial contacts and locations

11

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Data sourced from clinicaltrials.gov

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