A double-blind, parallel group-comparison trial of aripiprazole IM depot in patients with schizophrenia

A multicenter, active-controlled, double-blind, parallel group-comparison trial to investigate the efficacy and safety of aripiprazole IM depot (OPC-14597IMD) compared with aripiprazole tablets in patients with schizophrenia

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221140

Enrollment

410

Registered

2010-06-29

Start date

2010-06-29

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 time of informed consent

Exclusion criteria

Exclusion criteria: 1) Subjects diagnosed as having a mental disorder other than schizophrenia, as defined by DSM-IV-TR criteria 2) Subjects who meet 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
Non-exacerbation of psychotic symptoms/non-relapse rate in Phase 3 calculated by the Kaplan-Meier method	—

Secondary

Measure	Time frame
PANSS scale total score mean change	—

Outcome results

None listed

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