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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier:
NCT01726335
First received: November 9, 2012
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention Phase
Schizophrenia
Drug: Risperidone prolonged release
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study of Oral Antipsychotics Replacement by Prolonged Release Risperidone (Risperdal Consta) in Schizophrenic Subjects With Bad Adhesion to the Treatment

Resource links provided by NLM:


Further study details as provided by Janssen-Cilag Ltd.:

Primary Outcome Measures:
  • Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2 [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
    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.

  • Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4 [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    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.

  • Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    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.

  • Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
    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.

  • Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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.

  • Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38 [ Time Frame: Week 38 ] [ Designated as safety issue: No ]
    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.

  • Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50 [ Time Frame: Week 50 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Clinical Global Impressions (CGI) - Disease Severity Score [ Time Frame: Baseline and Week 2, 4, 8, 16, 24, 38 and 50 ] [ Designated as safety issue: No ]
    The CGI 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 indicates to "normal, not at all ill" and a rating of 7 indicates "among the most extremely ill participants". Higher scores indicate worsening.

  • Extrapyramidal Symptoms Rating Scale (ESRS) Total Score [ Time Frame: Baseline and Week 2, 4, 8, 16, 24 and 50 ] [ Designated as safety issue: Yes ]
    The ESRS is used to assess four types of drug-induced movement disorders administered as a questionnaire. Score range from 0 to 6 (0 is absent and 6 is extremely severe).

  • Drug Attitude Inventory (DAI-10) [ Time Frame: Screening, and Week 8, 24 and 50 ] [ Designated as safety issue: Yes ]
    The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).

  • Short Form-36 (SF-36) - Quality of Life [ Time Frame: Baseline and Week 50 ] [ Designated as safety issue: No ]
    The SF-36 is a survey of participant health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.

  • Personal and Social Performance (PSP) Scale Score [ Time Frame: Screening, and Week 8, 16, 24, 38 and 50 ] [ Designated as safety issue: No ]
    The PSP scale assesses the degree of a participant's dysfunction (ranging from i [absent] to vi [very severe) within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behavior. The overall score ranges from 1 to 100. Based on the 4-domains there was one total score. Participants with a score of 71 to 100 had a mild degree of difficulty; from 31 to 70, varying degrees of disability; participants with scores of 30 or less function so poorly as to require intensive supervision.

  • Global Assessment of Functioning (GAF) Scale Score [ Time Frame: Screening, and Week 8, 16, 24, 38 and 50 ] [ Designated as safety issue: No ]
    The GAF scale is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.


Enrollment: 53
Study Start Date: January 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Risperidone prolonged release
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
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.
Other Name: - Risperdal consta

Detailed Description:

This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of long-acting risperidone in participants with schizophrenia who have a previous history (in the last 12 months) of bad adherence to the oral antipsychotic treatment of first or second generation. The duration of this study will be 24 weeks and will include following visits: Screening, Baseline, Week 2, 4, 8, 12, 16, 20, 24, 38 and 50 (End visit or early withdrawal). All the eligible participants (after risperidone intolerance test during screening) will receive a dose of 25 milligram risperidone every two weeks by intramuscular injection (injection of a substance into a muscle). Efficacy and safety of the participants will primarily be evaluated by Positive and Negative Syndromes Scale and Extrapyramidal Symptom Rating Scale, respectively. Participants' safety will be monitored throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726335

Locations
Brazil
Curitiba, Brazil
Porto Alegre, Brazil
Rio De Janeiro, Brazil
Salvador, Brazil
Sao Paulo, Brazil
Sponsors and Collaborators
Janssen-Cilag Ltd.
Investigators
Study Director: Janssen-Cilag Ltd. Clinical trial Janssen-Cilag Ltd.
  More Information

No publications provided

Responsible Party: Janssen-Cilag Ltd.
ClinicalTrials.gov Identifier: NCT01726335     History of Changes
Other Study ID Numbers: CR012484, RISSCH4135
Study First Received: November 9, 2012
Results First Received: April 18, 2013
Last Updated: July 23, 2013
Health Authority: Brazil: Ethics Committee

Keywords provided by Janssen-Cilag Ltd.:
Schizophrenia
Risperidone
Risperdal consta

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Risperidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on April 17, 2014