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A Dose Reduction Trial of Long-Acting Injectable Second-Generation Antipsychotics in Stable Schizophrenia

Dose Reduction of Long-Acting Injectable Second-Generation Antipsychotics in Stable Schizophrenia: A Multicenter, Double-Blind, Randomized Controlled Trial - Dose Reduction of Long-Acting Injectable Second-Generation Antipsychotics in Stable Schizophrenia: A Multicenter, Double-Blind, Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000037282
Enrollment
200
Registered
2019-07-05
Start date
2020-03-13
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, Schizoaffective disorder

Interventions

Each of the LAI-SGAs will be reduced by 50% of the baseline dose and maintained at this dose for 52 weeks. For safety reasons, the dose will not be reduced beyond the minimum effective dose (i.e., 25

Sponsors

Keio University School of Medicine Department of Neuropsychiatry
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Outpatients having a diagnose of schizophrenia or schizoaffective disorder according to ICD-10 (2) Aged >= 18 years old (3) Having regularly and consecutively received LAI-risperidone >25 mg/2 weeks or LAI-paliperidone >50 mg/4 weeks at the same dose for at least 6 months as antipsychotic monotherapy. (4) Not having concomitantly received antipsychotics other than aripiprazole for more than 3 months. However, the concomitant use of quetiapine, chlorpromazine, or levomepromazine at a maximum dose of 50 mg/day at bedtime is allowed. (5) Having been in remission of positive symptoms defined as a score of <=3 on all of the following 5 PANSS items: delusion (item P1), unusual thought content (item G9), hallucinatory behavior (item P3), conceptual disorganization (item P2), and mannerisms and posturing (item G5) (6) Having provided written informed consent

Exclusion criteria

Exclusion criteria: (1) Having a history of obvious harm to him/herself and/or others (2) Having significant physical or neurological illnesses (3) Having a diagnose of mental and behavioral disorders due to psychoactive substance use according to ICD-10 (4) Being pregnant or lactating (5) Having been judged as unable to provide informed consent by a person who explains the study (6) Being prohibited to receive reimbursement (in cases such as receiving public assistance and being prohibited from receiving reimbursement by the public assistance case worker) (7) Having been judged as unsuitable for the study for other reasons by the principal investigator

Design outcomes

Primary

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

Countries

Japan

Contacts

Public ContactHiroyoshi Takeuchi

Keio University School of Medicine Department of Neuropsychiatry

hirotak@dk9.so-net.ne.jp03-5363-3829

Outcome results

None listed

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