Repeated-dose trial of aripiprazole IM depot in patients with schizophrenia

Open-label, Multicenter Trial to Investigate the Pharmacokinetics of Aripiprazole IM Depot Fornulation (OPC-14597 IMD) by Repeated Dosing in Patients with Schizophrenia

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221487

Enrollment

Registered

2011-06-22

Start date

2011-06-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

investigational material(s) Generic name etc : Aripiprazole INN of investigational material : Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational materia

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Subjects with a current diagnosis of schizophrenia as defined by DSM-IV-TR criteria 2) Subjects who provide written consent personally 3) Male and female subjects aged 18 years or older at the time of informed consent

Exclusion criteria

Exclusion criteria: 1) Subjects diagnosed as having a mental disorder other than schizophrenia as defined by DMS-IV-TR criteria 2) Subjects who fall under the conditions for contraindication according to the package insert of Abilify 3) Subjects who have been judged by the investigator or subinvestigator to be inappropriate for inclusion in this trial for any other reasons

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics Before administration to 4 weeks after post-treatment observation	—

Secondary

Measure	Time frame
Safety After informed consent is obtained to 4 weeks after post-treatment observation	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026