An Efficacy and Safety Study of Long-acting Risperidone in Participants With Schizophrenia or Schizoaffective Disorders Who Are Receiving Psychiatric Home Care Treatment

NCT00526877 | Completed Phase 4

• 2 other identifiers: CR013873RISSCH4119
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of long-acting risperidone microspheres (small uniformly-sized spherical particles, of micrometer dimensions, frequently labeled with radioisotopes or various reagents acting as tags or markers) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) and schizoaffective disorders (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder), who are receiving psychiatric home-care treatment .

Conditions

Schizophrenia; Schizoaffective Disorders

Keywords

Schizophrenia; Schizoaffective disorders; Risperidone; Risperdal Consta

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Positive and Negative Syndromes 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

Secondary Outcomes (6)

• Personal and Social Performance (PSP) Scale Score

  Screening (28 days before study drug administration), Baseline and Week 24

• Clinical Global Impression (CGI) Scale Score

  Screening (28 days before study drug administration), Baseline and Week 24

• Short Form-36 (SF-36) - Quality of Life Score

  Screening (28 days before study drug administration), Baseline and Week 24

• Change From Baseline in Simpson Angus Rating Scale (SAS) Score at Week 24

  Baseline and Week 24

• Change From Baseline in Extrapyramidal Symptoms Rating Scale (ESRS) Total Score at Week 24

  Baseline and Week 24

Study Arms (1)

Risperidone

EXPERIMENTAL

Risperidone long-acting injectable 25 milligram (mg) or 37.5 mg or 50 mg will be administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 24 weeks.

Drug: Risperidone

Interventions

Risperidone DRUG

Risperidone long-acting injectable 25 milligram (mg) or 37.5 mg or 50 mg will be administered intramuscularly (into a muscle) depending on Investigator's discretion every 2 weeks for 24 weeks.

Also known as: Risperdal Consta

Risperidone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet the diagnostic criteria for schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
• Participant has been given an adequate dose of an appropriate antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsatisfactory due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
• Female participants must be postmenopausal, surgically sterile, or practicing an effective method of birth control before entry and throughout the study; have a negative urine betahuman chorionic gonadotropin (HCG) pregnancy test at screening; and a negative urine pregnancy test on screening visit
• Participants or their legally acceptable representatives must have signed an informed consent document

You may not qualify if:

• Participants with a primary, active DSM-IV diagnosis other than schizophrenia and schizoaffective disorder
• Participants with relevant history or current presence of any significant and/or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic or other systemic disease
• Participants that are previously on concomitant use of Risperdal CONSTA
• History or current symptoms of tardive dyskinesia
• History of neuroleptic malignant syndrome (NMS)

Sponsors & Collaborators

• Johnson & Johnson Taiwan Ltd: lead

Related Links

• An Efficacy and Safety Study of Long-acting Risperidone in Participants with Schizophrenia or Schizoaffective disorders who are Receiving Psychiatric Home Care Treatment

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Taiwan, Ltd. Clinical Trial

  Johnson & Johnson Taiwan Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: July 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: February 28, 2014

Record last verified: 2014-02