Back to resultsAn Efficacy and Safety Study of Long-Term Risperidone Microspheres in Participants With Schizophrenia
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Risperidone Long-Acting Injectable (RLAI)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Risperidone, Risperidal Consta
Eligibility Criteria
Inclusion Criteria: Participants diagnosed with schizophrenia or schizoaffective disorder (in-patients or out-patients) Participants currently having their symptoms well controlled with a stable dose of oral antipsychotic medication Participants who have signed informed consent form Exclusion Criteria: Participants who have never received any previous antipsychotic treatment Participants who have received clozapine during the last 3 months Participants with a serious unstable medical condition, including laboratory abnormalities Participants with a history of, or current symptoms of tardive dyskinesia (a complication of neuroleptic therapy involving involuntary movements of facial muscles) or neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness) Female participants who are pregnant or breast-feeding, or are of childbearing age without adequate contraception
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Risperidone Long-Acting Injectable (RLAI)
Arm Description
The RLAI 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 2 years.
Outcomes
Primary Outcome Measures
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score at Week 96
The PANSS is a 30-item scale consisting of 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items) and it is designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 items are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
Secondary Outcome Measures
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 96
The CGI-S rating scale is used to rate the severity of a participant's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.
Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 96
GAF 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. Lower scores indicate worsening.
Change From Baseline in World Health Organization (WHO)-Quality of Life (QOL) at Week 96
The WHOQOL-BREF is a 26-item, self-report questionnaire and short version of WHOQOL-100, consisting of 4 domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Each individual item of the WHOQOL-BREF is scored from 1=not at all to 5=completely on a response scale, which is stipulated as a 5-point ordinal scale. The scores are then transformed linearly to a scale of 0 (the worse quality of life) to 100 (the worse quality of life).
Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96
The K-WAIS is a Korean version of the Wechsler Adult Intelligence Scale-Revised (WAIS-R). It is an intelligence test that assess 3 general areas of intelligence quotients (IQ): verbal IQ, performance IQ and full-scale IQ (FSIQ). The verbal IQ includes: Digit Span, Vocabulary, and Arithmetic; performance IQ includes: Picture Arrangement and Block Design; and FSIQ is an IQ assessed by measuring an individual's overall level of general cognitive and intellectual functioning. The highest FSIQ is 160. The greater the quotient, higher the level of intelligence.
Change From Baseline in NCFT: Controlled Oral Word Association Test at Week 96
The Controlled Oral Word Associated Test is a measure of verbal fluency, which requires participants to generate words orally that begin with a given letter of the alphabet. Participants are given 1 min to name as many words as possible. Performance was calculated by the number of words generated in the 1-min period. This measure, requiring rapid and organized word retrieval, is a sensitive indicator of brain dysfunction.
Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
The KAVLT is a neuropsychological assessment designed to evaluate verbal memory in participants. The KAVLT is useful in evaluating the nature and severity of memory dysfunction and to track changes in memory function over time. The test is designed as a list-learning paradigm in which the participants hears a list of 15 words, and are asked to recall as many words from the list as possible. This procedure is carried out a total of 5 times. Then a second list of 15 words is presented, allowing the participants only 1 attempt to recall. Immediately following this, the participants are asked to remember as many words as possible from the first list. KAVLT consists of 2 test conditions: Delayed Recall and Delayed Recognition. The upper limit for 'words recalled' is 15, which represents better episodic memory.
Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96
The RCFT is a neuropsychological assessment designed to evaluate visual memory in participants. The RCFT is useful in evaluating the spatial perception and visual memory. The RCFT consists of 3 test conditions: Copy, Immediate Recall and Delayed Recall. At the first step, participants are given the RCFT stimulus card, and then asked to draw the same figure. Subsequently, they are instructed to draw what they remembered. Then, after a delay of 30 min, they are required to draw the same figure once again, a score of 2 points for each drawn element (a complete straight line or a circle) remembered correctly. The total score is the sum of points scored for each correctly drawn element and it ranges from 0 to 36. The maximum score indicates excellent visual memory.
Change From Baseline in NCFT: Memory Quotient (MQ) at Week 96
MQ was obtained by adding up the results of verbal memory and visual memory test. The memory quotient will include learning curve, memory retention, retrieval efficiency, drawing/memory consistency, verbal/visual memory consistency and intelligence/memory consistency. The highest MQ is 160, which indicates excellent memory.
Change From Baseline in NCFT: Trail Making Test (TMT)-Time at Week 96
TMT is attention, mental flexibility, visual search, motor function measure test. Test is divided into A and B types. Participants using a pencil or connect numbers in sequence (A-type), in turn, alternating between numbers and letters must be connected (B-type). The test measures the response time.
Change From Baseline in NCFT: TMT-Error at Week 96
TMT is attention, mental flexibility, visual search, motor function measure test. Test is divided into A and B types. Participants using a pencil or connect numbers in sequence (A-type), in turn, alternating between numbers and letters must be connected (B-type). The test measures the the number of errors.
Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) Score
The LUNSERS is a self-report measure of antipsychotic side effects. It consists of 51 questions, 41 questions on side effects and 10 questions are of "red herrings" to validate the results. Each question is rated on a 4-point scale, where 0=not at all; and 4=very much. The total neuroleptic side effect score is the sum of the scores for the side effects items (i.e. all items excluding the red herrings). Total side effects score ranges from 0 to 164, where 0 to 40=low side effect rating, 41 to 80=medium side effect rating and greater than 81=high side effect rating.
Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Item Scale Score at Week 96
The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of medication and 2) attitudes and beliefs toward neuroleptics which may influence medication 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 for each person at each time is the positive score minus the negative score.
Total Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) Score
A scale used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.
Full Information
NCT ID
NCT00269919
First Posted
December 22, 2005
Last Updated
March 25, 2014
Sponsor
Janssen Korea, Ltd., Korea
1. Study Identification
Unique Protocol Identification Number
NCT00269919
Brief Title
An Efficacy and Safety Study of Long-Term Risperidone Microspheres in Participants With Schizophrenia
Official Title
Effect on Efficacy, Safety and Quality of Life by Long-Term Treatment of Long-Acting Risperidone Microspheres in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Korea, Ltd., Korea
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the long-term efficacy and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) and its influence on quality of life, 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) single-arm, and prospective study (study following participants forward in time) of risperidone microspheres in participants with schizophrenia. Participants will be treated with intramuscular (into a muscle) injections of either 25 milligram (mg) or 37.5 mg or 50 mg of risperidone twice weekly, every 2 weeks for 2 years. The total duration of study will be 2 years. The efficacy of participants will primarily be evaluated by total Positive and Negative Syndrome Scale (PANSS) score. Participants' quality of life and 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, Schizoaffective Disorder
Keywords
Schizophrenia, Risperidone, Risperidal 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
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Risperidone Long-Acting Injectable (RLAI)
Arm Type
Experimental
Arm Description
The RLAI 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 2 years.
Intervention Type
Drug
Intervention Name(s)
Risperidone Long-Acting Injectable (RLAI)
Intervention Description
The RLAI 25 mg or 37.5 mg or 50 mg will be administered intramuscularly depending on Investigator's discretion every 2 weeks for 2 years.
Primary Outcome Measure Information:
Title
Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score at Week 96
Description
The PANSS is a 30-item scale consisting of 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items) and it is designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 items are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
Time Frame
Baseline and Week 96
Secondary Outcome Measure Information:
Title
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 96
Description
The CGI-S rating scale is used to rate the severity of a participant's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill. Higher scores indicate worsening.
Time Frame
Baseline and Week 96
Title
Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 96
Description
GAF 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. Lower scores indicate worsening.
Time Frame
Baseline and Week 96
Title
Change From Baseline in World Health Organization (WHO)-Quality of Life (QOL) at Week 96
Description
The WHOQOL-BREF is a 26-item, self-report questionnaire and short version of WHOQOL-100, consisting of 4 domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items); it also contains QOL and general health items. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score. Each individual item of the WHOQOL-BREF is scored from 1=not at all to 5=completely on a response scale, which is stipulated as a 5-point ordinal scale. The scores are then transformed linearly to a scale of 0 (the worse quality of life) to 100 (the worse quality of life).
Time Frame
Baseline and Week 96
Title
Change From Baseline in Neurocognitive Function Test (NCFT): General Intelligence (Korean-Wechsler Adults Intelligence Scale [K-WAIS]) at Week 96
Description
The K-WAIS is a Korean version of the Wechsler Adult Intelligence Scale-Revised (WAIS-R). It is an intelligence test that assess 3 general areas of intelligence quotients (IQ): verbal IQ, performance IQ and full-scale IQ (FSIQ). The verbal IQ includes: Digit Span, Vocabulary, and Arithmetic; performance IQ includes: Picture Arrangement and Block Design; and FSIQ is an IQ assessed by measuring an individual's overall level of general cognitive and intellectual functioning. The highest FSIQ is 160. The greater the quotient, higher the level of intelligence.
Time Frame
Baseline and Week 96
Title
Change From Baseline in NCFT: Controlled Oral Word Association Test at Week 96
Description
The Controlled Oral Word Associated Test is a measure of verbal fluency, which requires participants to generate words orally that begin with a given letter of the alphabet. Participants are given 1 min to name as many words as possible. Performance was calculated by the number of words generated in the 1-min period. This measure, requiring rapid and organized word retrieval, is a sensitive indicator of brain dysfunction.
Time Frame
Baseline and Week 96
Title
Change From Baseline in NCFT: Rey Kim Memory Test-Korean Auditory Verbal Learning Test (KAVLT) at Week 96
Description
The KAVLT is a neuropsychological assessment designed to evaluate verbal memory in participants. The KAVLT is useful in evaluating the nature and severity of memory dysfunction and to track changes in memory function over time. The test is designed as a list-learning paradigm in which the participants hears a list of 15 words, and are asked to recall as many words from the list as possible. This procedure is carried out a total of 5 times. Then a second list of 15 words is presented, allowing the participants only 1 attempt to recall. Immediately following this, the participants are asked to remember as many words as possible from the first list. KAVLT consists of 2 test conditions: Delayed Recall and Delayed Recognition. The upper limit for 'words recalled' is 15, which represents better episodic memory.
Time Frame
Baseline and Week 96
Title
Change From Baseline in NCFT: Rey Kim Memory Test- Korean-Rey Complex Figure Test (K-RCFT) at Week 96
Description
The RCFT is a neuropsychological assessment designed to evaluate visual memory in participants. The RCFT is useful in evaluating the spatial perception and visual memory. The RCFT consists of 3 test conditions: Copy, Immediate Recall and Delayed Recall. At the first step, participants are given the RCFT stimulus card, and then asked to draw the same figure. Subsequently, they are instructed to draw what they remembered. Then, after a delay of 30 min, they are required to draw the same figure once again, a score of 2 points for each drawn element (a complete straight line or a circle) remembered correctly. The total score is the sum of points scored for each correctly drawn element and it ranges from 0 to 36. The maximum score indicates excellent visual memory.
Time Frame
Baseline and Week 96
Title
Change From Baseline in NCFT: Memory Quotient (MQ) at Week 96
Description
MQ was obtained by adding up the results of verbal memory and visual memory test. The memory quotient will include learning curve, memory retention, retrieval efficiency, drawing/memory consistency, verbal/visual memory consistency and intelligence/memory consistency. The highest MQ is 160, which indicates excellent memory.
Time Frame
Baseline and Week 96
Title
Change From Baseline in NCFT: Trail Making Test (TMT)-Time at Week 96
Description
TMT is attention, mental flexibility, visual search, motor function measure test. Test is divided into A and B types. Participants using a pencil or connect numbers in sequence (A-type), in turn, alternating between numbers and letters must be connected (B-type). The test measures the response time.
Time Frame
Baseline and Week 96
Title
Change From Baseline in NCFT: TMT-Error at Week 96
Description
TMT is attention, mental flexibility, visual search, motor function measure test. Test is divided into A and B types. Participants using a pencil or connect numbers in sequence (A-type), in turn, alternating between numbers and letters must be connected (B-type). The test measures the the number of errors.
Time Frame
Baseline and Week 96
Title
Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS) Score
Description
The LUNSERS is a self-report measure of antipsychotic side effects. It consists of 51 questions, 41 questions on side effects and 10 questions are of "red herrings" to validate the results. Each question is rated on a 4-point scale, where 0=not at all; and 4=very much. The total neuroleptic side effect score is the sum of the scores for the side effects items (i.e. all items excluding the red herrings). Total side effects score ranges from 0 to 164, where 0 to 40=low side effect rating, 41 to 80=medium side effect rating and greater than 81=high side effect rating.
Time Frame
Baseline and Week 96
Title
Change From Baseline in Drug Attitude Inventory-10 (DAI-10) Item Scale Score at Week 96
Description
The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of medication and 2) attitudes and beliefs toward neuroleptics which may influence medication 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 for each person at each time is the positive score minus the negative score.
Time Frame
Baseline and Week 96
Title
Total Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) Score
Description
A scale used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 9 items (8 to assess individual symptoms and 1 to assess global severity). Each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.
Time Frame
Baseline and Week 96
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants diagnosed with schizophrenia or schizoaffective disorder (in-patients or out-patients)
Participants currently having their symptoms well controlled with a stable dose of oral antipsychotic medication
Participants who have signed informed consent form Exclusion Criteria:
Participants who have never received any previous antipsychotic treatment
Participants who have received clozapine during the last 3 months
Participants with a serious unstable medical condition, including laboratory abnormalities
Participants with a history of, or current symptoms of tardive dyskinesia (a complication of neuroleptic therapy involving involuntary movements of facial muscles) or neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness)
Female participants who are pregnant or breast-feeding, or are of childbearing age without adequate contraception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Korea, Ltd., Korea Clinical Trial
Organizational Affiliation
Janssen Korea, Ltd., Korea
Official's Role
Study Director
Facility Information:
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
An Efficacy and Safety Study of Long-Term Risperidone Microspheres in Participants With Schizophrenia
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