Clinical trial NCT01894984: An Observational Study to Evaluate Efficacy and Safety of Risperidone Long-Acting Injection for Treatment of Schizophrenia
Official title: Clinical Observation of the Efficacy and Safety of Risperidone Long-Acting Injection (Risperdal Consta) in the Treatment of Schizophrenia in China
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Schizophrenia
Keywords: Schizophrenia
Risperidone
Risperdal Consta
Oral antipsychotic
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2013-07-10
Enrollment: 640
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant must meet the diagnostic criteria for schizophrenia or schizophreniform disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)

Brief 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).

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 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

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Total Personal and Social Performance (PSP) Score
timeFrame: Baseline and Week 24
measure: Clinical Global Impressions-Severity (CGI-S) Score
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Relapse at Week 24
timeFrame: Week 24
measure: Percentage of Participants Attaining Remission Criteria
timeFrame: Month 6
measure: Number of Participants With Reasons for Discontinuation From Study Treatment
timeFrame: Month 6
Other outcomes:
Locations:
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: STUDY_DIRECTOR
References: