Pharmacokinetics differences in risperidone and 9-OH risperidone: relation to inserted depth of injection needle in the people with schizophrenia who treated with regularly risperidone long acting injection (RLAI).

Pharmacokinetics differences in risperidone and 9-OH risperidone: relation to inserted depth of injection needle in the people with schizophrenia who treated with regularly risperidone long acting injection (RLAI). - Pharmacokinetics differences in risperidone and 9-OH risperidone: relation to inserted depth of injection needle in the people with schizophrenia who treated with regularly risperidone long acting injection (RLAI).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012301

Enrollment

Registered

2013-12-08

Start date

2013-12-09

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

Group to deeply (50mm from the surface of patient&#39

s skin) penetrate the RLAI needle Group to shallowly (20mm from the surface of patient&#39

s skin) penetrate the RLAI needle

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subjects will be patients meeting all of the following criteria. 1) Patients with F2 criteria meeting the ICD-10 diagnosis 2) Patients who had previously enrolled to the Research on nursing technique in intramuscular injection. 3) Patients who personally give written informed consent to participate in the study. 4) Patients who require treatment with risperidone long acting injection (RLAI), and all of whom being administered RLAI regularly for more than 6 weeks to the the base lined date of the study 5) Inpatients or outpatients 6) Patients who personally give written informed consent to obtain information about CYP2D6 gene polymorphism.

Exclusion criteria

Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study. 1) PANSS total score over 130 points. 2) Patients who need to be treated with risperidone or paliperidone during this research.

Design outcomes

Primary

Measure	Time frame
Serum concentration of risperidone and 9-OH risperidone	—

Secondary

Measure	Time frame
1) Positive and Negative Syndrome Scale; PANSS 2) Clinical Global Impression; CGI 3) Drug-induced Extrapyramidal Symptoms Scale; DIEPSS 4) Visual Analogue Scale; VAS 5) Injection Site Reactions 6) Demography 7) Concomitant Medications 8) Cost(i.e. medical remuneration points ) 9) CYP2D6 gene polymorphism 10) Brain-derived neurotorophic factor; BDNF	—

Countries

Japan

Contacts

Public ContactSoji Tsuboi

Okehazama Hospital Fujita Kokoro Care Center Nursing Division

crc-tsuboi.so@seishinkai-kokoro.jp(0562)98-1830

Outcome results

None listed

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