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A Study of Usage of Paliperidone Palmitate in Patients With Schizophrenia in a Hospital Setting (HOSPIPalm)

Janssen (J&J Innovative Medicine) logo

Janssen (J&J Innovative Medicine)

Status

Completed

Conditions

Schizophrenia

Treatments

Drug: No intervention

Study type

Observational

Funder types

Industry

Identifiers

NCT01926912
R092670SCH4017 (Other Identifier)
CR100862

Details and patient eligibility

About

The purpose of this study to evaluate safety, tolerability, treatment outcomes, appropriate use and pattern of paliperidone palmitate usage in participants with schizophrenia in the hospital setting.

Full description

This is a prospective (look forward using periodic observations collected predominantly following patient enrollment), multicenter, observational study (a type of study in which participants are observed or certain outcomes are measured). This study will consist of 6-week observational period during which data will be collected for participants who are hospitalized due to schizophrenia exacerbation and are receiving treatment with paliperidone palmitate (treatment initiated within 3 weeks after admission to hospital). The participant satisfaction will be evaluated at week 6 (or early discontinuation). Safety evaluations will include body weight, extrapyramidal symptom (eg, inability to initiate movement and inability to remain motionless) rating scale scores, concomitant therapy and assessment of adverse events.

Enrollment

371 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants diagnosed with schizophrenia
  • Participant admitted to hospital due to an exacerbation of their schizophrenia prior to any study-related activity
  • Participant may, in the opinion of the participating physician, benefit from treatment with paliperidone palmitate which will be initiated within 3 weeks after admission to hospital

Exclusion criteria

  • Participant has a known hypersensitivity to paliperidone or risperidone
  • Participant has previously been treated with paliperidone palmitate
  • Participant has a history of neuroleptic malignant syndrome
  • Participant was on clozapine or has previously been treated with any long-acting injectable antipsychotic during the last 3 months

Trial design

371 participants in 1 patient group

Participants with schizophrenia
Treatment:
Drug: No intervention

Trial contacts and locations

39

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Data sourced from clinicaltrials.gov

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