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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01894984
• Other study ID #: CR013483
• Secondary ID: RISSCH4191
• Status: Terminated
• Phase: Phase 4
• First received: July 3, 2013
• Last updated: April 22, 2014
• Start date: January 2007
• Est. completion date: December 2009

Study information

• Verified date: April 2014
• Source: Xian-Janssen Pharmaceutical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 640
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Risperidone
This is an observational study. 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.
• Oral atypical anti-psychotic
This is an observational study. Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc will be administered as per Investigator's discretion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xian-Janssen Pharmaceutical Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 24	The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.	Baseline and Week 24	No
Secondary	Total Personal and Social Performance (PSP) Score	The PSP is a clinician-rated scale that reflects social functioning in 4 domains of behavior (socially useful activities including work and study, personal and social relationships, self care, and disturbing and aggressive behaviors). The total score ranges from 1 to 100 (score of 71 to 100 will have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision) divided into 10 equal intervals to rate the degree of difficulty (i=absent to vi=very severe) in each of the 4 domains.	Baseline and Week 24	No
Secondary	Clinical Global Impressions-Severity (CGI-S) Score	The CGI-S rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.	Baseline and Week 24	No
Secondary	Percentage of Participants With Relapse at Week 24	Percentage of participants with relapse was assessed wherein relapse was defined as hospitalization due to the aggravation of psychiatric symptoms of disease condition.	Week 24	No
Secondary	Percentage of Participants Attaining Remission Criteria	Remission is defined as a clinical status where for each core symptoms (that are, delusions, conceptual disorganization, hallucinatory behavior, mannerisms and posturing unusual thought content, blunted affect, passive or apathetic social withdrawal and lack of spontaneity and flow of conversation) were assessed at a low-mild symptom intensity level, where such absent, borderline, or mild symptoms do not influence an individual's behavior.	Month 6	No
Secondary	Number of Participants With Reasons for Discontinuation From Study Treatment	Number of participants with reasons for discontinuation from study treatment is reported here because participants provided multiple reasons for discontinuation.	Month 6	No