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Effect brexpiprazole augmentation for aripiprazole one-monthly on cognitive functioning in Japanese schizophrenia: A Randomized Controlled Clinical Trial

Effect brexpiprazole augmentation for aripiprazole one-monthly on cognitive functioning in Japanese schizophrenia: A Randomized Controlled Clinical Trial - BREATH-JM

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000043576
Enrollment
60
Registered
2021-04-01
Start date
2021-03-31
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

Aripiprazole once-monthly will be maintained at the same dose as baseline for 24 weeks. Brexpiprazole will be augmented with aripiprazole once-monthly for 24 weeks.

Sponsors

Department of Neuropsychiatry, Kansai Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Outpatients having a diagnose of schizophrenia or schizoaffective disorder according to ICD-10 Patients who have not been hospitalized in a psychiatric unit in the past 6 months Baseline total score 120 or less on the PANSS total score Having regularly and consecutively received aripiprazole once-monthly for at least 2 months Having provided written informed consent

Exclusion criteria

Exclusion criteria: Serious complication Active suicidal ideations or past suicide attempts Drug or alcohol abuse Pregnant or breast-feeding females mental retardation Using of oral aripiprazole or asenapine, blonanserin Having been judged as unsuitable for the study forin other reasons by an principal investigator

Design outcomes

Primary

MeasureTime frame
Change in Brief Assessment of Cognition in Schizophrenia (BACS) composite scores from week 0 to week 24

Secondary

MeasureTime frame
Remission rate, Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression-Severity scale (CGI-S), Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS), UKU Side Effect Scale(UKU), Barnes Akathisia Rating Scale (BARS), Epworth Sleepness Scale(ESS), body weight, Body Mass Index, blood biochemistry, Japanese Adult Reading Test (JART), electroencephalography

Countries

Japan

Contacts

Public ContactYoshiteru Takekita

Kansai Medical University Department of Neuropsychiatry

takekity@takii.kmu.ac.jp0669921001

Outcome results

None listed

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