Back to resultsSwitching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Risperidone prolonged release
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Risperidone, Risperdal consta
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Risperidone prolonged release
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
Clinical Global Impressions (CGI) - Disease Severity Score
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
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)
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01726335
Brief Title
Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Risperidone, Risperdal consta
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risperidone prolonged release
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Risperidone prolonged release
Other Intervention Name(s)
- Risperdal consta
Intervention Description
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.
Primary Outcome Measure Information:
Title
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2
Description
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.
Time Frame
Week 2
Title
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4
Description
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.
Time Frame
Week 4
Title
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8
Description
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.
Time Frame
Week 8
Title
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16
Description
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.
Time Frame
Week 16
Title
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24
Description
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.
Time Frame
Week 24
Title
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38
Description
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.
Time Frame
Week 38
Title
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50
Description
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.
Time Frame
Week 50
Secondary Outcome Measure Information:
Title
Clinical Global Impressions (CGI) - Disease Severity Score
Description
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.
Time Frame
Baseline and Week 2, 4, 8, 16, 24, 38 and 50
Title
Extrapyramidal Symptoms Rating Scale (ESRS) Total Score
Description
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).
Time Frame
Baseline and Week 2, 4, 8, 16, 24 and 50
Title
Drug Attitude Inventory (DAI-10)
Description
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).
Time Frame
Screening, and Week 8, 24 and 50
Title
Short Form-36 (SF-36) - Quality of Life
Description
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.
Time Frame
Baseline and Week 50
Title
Personal and Social Performance (PSP) Scale Score
Description
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.
Time Frame
Screening, and Week 8, 16, 24, 38 and 50
Title
Global Assessment of Functioning (GAF) Scale Score
Description
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.
Time Frame
Screening, and Week 8, 16, 24, 38 and 50
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag Ltd. Clinical trial
Organizational Affiliation
Janssen-Cilag Ltd.
Official's Role
Study Director
Facility Information:
City
Curitiba
Country
Brazil
City
Porto Alegre
Country
Brazil
City
Rio De Janeiro
Country
Brazil
City
Salvador
Country
Brazil
City
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia
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