Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia

NCT01726335 | Completed Phase 4 Results

• 2 other identifiers: CR012484RISSCH4135
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Schizophrenia

Keywords

Schizophrenia; Risperidone; Risperdal consta

Outcome Measures

Primary Outcomes (7)

• Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2

  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.

  Week 2

• Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4

  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.

  Week 4

• Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8

  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.

  Week 8

• Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16

  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.

  Week 16

• 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.

  Week 24

• Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38

  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.

  Week 38

• Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50

  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.

  Week 50

Secondary Outcomes (6)

• Clinical Global Impressions (CGI) - Disease Severity Score

  Baseline and Week 2, 4, 8, 16, 24, 38 and 50

• Extrapyramidal Symptoms Rating Scale (ESRS) Total Score

  Baseline and Week 2, 4, 8, 16, 24 and 50

• Drug Attitude Inventory (DAI-10)

  Screening, and Week 8, 24 and 50

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

  Baseline and Week 50

• Personal and Social Performance (PSP) Scale Score

  Screening, and Week 8, 16, 24, 38 and 50

Study Arms (1)

Risperidone prolonged release

EXPERIMENTAL

Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.

Drug: Risperidone prolonged release

Interventions

Risperidone prolonged release DRUG

Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.

Also known as: - Risperdal consta

Risperidone prolonged release

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
• Be on treatment with oral antipsychotic of first or second generation, for a minimum time of 12 months
• Previous history of bad adhesion to oral antipsychotic treatment in the last 12 months
• Total Positive and Negative Syndrome Scale score less than or equal to 90, the conceptual disorganization, hallucinatory behavior, suspicion and not usual content of thought must be less than or equal to 4
• Be not pregnant as showed on negative pregnancy serum test

You may not qualify if:

• Contraindication or known hypersensitivity to risperidone
• Previous history of unsatisfactory response to risperidone
• Previous history of refractivity to the other second generation antipsychotics
• Use of antipsychotic of intramuscular deposit in the last 12 months
• Other mental disturbances of DSM-IV axis

Sponsors & Collaborators

• Janssen-Cilag Ltd.: lead

Study Sites (5)

Unknown Facility

Curitiba, Brazil

Location

Unknown Facility

Porto Alegre, Brazil

Location

Unknown Facility

Rio de Janeiro, Brazil

Location

Unknown Facility

Salvador, Brazil

Location

Unknown Facility

São Paulo, Brazil

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Group Manager
• Organization: Janssen-Cilag Ltd.

+55 11 30302738

Study Officials

• Janssen-Cilag Ltd. Clinical trial

  Janssen-Cilag Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: November 9, 2012
• First Posted: November 14, 2012
• Study Start: January 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 29, 2014
• Results First Posted: July 24, 2013

Record last verified: 2014-04

Locations

BR (5)