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A prospective cohort study of the efficacy and safety of paliperidone palmitate injection (PP1M) or oral paliperidone in adolescents with schizophrenia

A prospective cohort study of the efficacy and safety of paliperidone palmitate injection (PP1M) or oral paliperidone in adolescents with schizophrenia

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085792
Enrollment
Unknown
Registered
2024-06-18
Start date
2024-06-18
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Schizophrenia

Interventions

PPLAI group:PP1M (Invega Sustenna): Patients received PP1M 150 mg eq and 100 mg eq in the deltoid muscle on days 1 and 8, respectively. After one month, according to the patients tolerance and efficac
PP oral medication group:Usage and dosage of paliperidone extended-release tablets: refer to the usage and dosage of drug instructions

Sponsors

Children and Adolescent Psychology Department of Tianjin Anding Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1) Between 12-17 years old, weighing 29kg; 2) Meet the diagnostic criteria of DSM-5 for schizophrenia; 3) Total score of PANSS exceeds 40; 4) Willing and able to complete the questionnaire independently; 5) Be able to complete the study visit required by the protocol; 6) The subject and the legal representative voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) The main effective diagnosis of DSM-5 non-schizophrenia; 2) Previous or current presence of any serious or unstable physical disease; 3) Previous nerve blocker malignant syndrome (NMS) or delayed motor disorder; 4) History of paliperidone resistance, defined as the sufficient course of treatment recorded in the history; 5) Subjects with known or suspected allergy or intolerance to paliperidone or any of its excipients; 6) Previous or current use of clozapine in treatment-refractory schizophrenia; 7) With 2 or more antipsychotic drugs (unified with combined drugs, whether patients with multiple antipsychotics can be converted to paliperidone molecular monotherapy) 8) Unable to provide the informed consent.

Design outcomes

Primary

MeasureTime frame
PANSS;PSP;CGI-S;

Countries

China

Contacts

Public ContactSun ling

Tianjin Anding Hospital

adertong@163.com+86 136 2210 6122

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026