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

Janssen (J&J Innovative Medicine)

Status: Terminated

Conditions: Schizophrenia

Treatments: Drug: Risperidone; Drug: Oral atypical anti-psychotic

Study type: Observational

Funder types: Industry

Identifiers

NCT01894984

CR013483

RISSCH4191

Details and patient eligibility

About

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).

Full 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.

Enrollment: 640 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

640 participants in 2 patient groups

Risperidone

Description:

Risperidone will be administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose will be decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may be increased or decreased at physician discretion. For first three weeks, previous oral antipsychotic drug (Benzodiazepines or Selective serotonin reuptake inhibitor \[SSRI\]) will be maintained and will cease at Week 3.

Treatment:

Drug: Risperidone

Oral atypical anti-psychotic

Description:

Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc will be administered as per Investigator's discretion.

Treatment:

Drug: Oral atypical anti-psychotic