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An Observational Study to Evaluate Efficacy and Safety of Risperidone Long-Acting Injection for Treatment of Schizophrenia

Information source: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Risperidone (Drug); Oral atypical anti-psychotic (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: Xian-Janssen Pharmaceutical Ltd.

Official(s) and/or principal investigator(s):
Xian-Janssen Pharmaceutical Ltd., China Clinical Trial, Study Director, Affiliation: Xian-Janssen Pharmaceutical Ltd.

Summary

The purpose of this study is to evaluate the long-term treatment efficacy, and safety of risperidone long-acting injection in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Clinical Details

Official title: Clinical Observation of the Efficacy and Safety of Risperidone Long-Acting Injection (Risperdal Consta) in the Treatment of Schizophrenia in China

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24

Secondary outcome:

Total Personal and Social Performance (PSP) Score

Clinical Global Impressions-Severity (CGI-S) Score

Percentage of Participants With Relapse at Week 24

Percentage of Participants Attaining Remission Criteria

Number of Participants With Reasons for Discontinuation From Study Treatment

Detailed description: This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center), prospective (study following participants forward in time) and observational study of risperidone long-acting injection in participants with schizophrenia. The study consists of 2 parts: Screening (that is, 28 days before study commences on Day 1) and Treatment (that is, Week 1-24). All the eligible participants (after risperidone intolerance test during screening) will be receiving risperidone as intramuscular injection (injection of a substance into a muscle) at a dose of, either 25 milligram (mg), 37. 5 mg or 50 mg every two weeks. Efficacy of the participants will be primarily evaluated through Positive and Negative Syndrome Scale. Participants' safety will be monitored throughout the study.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female, age 18-65 years

- Participant must meet the diagnostic criteria for schizophrenia or schizophreniform

disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)-TM

- Total course of disease no more than 5 years

- According to physician's discretion, participants need to be changed to risperidone

long-acting injection and other atypical anti-psychotic drug

- Participant or their legally acceptable representatives must have signed an informed

consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Exclusion Criteria:

- Significant risk of suicidal or violent behavior, as clinically assessed by the

Investigator

- Have aggressive behavior and excited , restless

- History or current symptoms of tardive dyskinesia; neuroleptic malignant syndrome;

evidence of dysfunction of liver and kidney and other severe physical diseases; and severe, life-threatening allergic reaction to any drug

- Known hypersensitivity to risperidone

- Female participant who is pregnant or breastfeeding or planning to become pregnant

during the study period

Locations and Contacts

Additional Information

Starting date: January 2007
Last updated: April 22, 2014

Page last updated: August 23, 2015

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