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| ID | Type | Description | Link |
|---|---|---|---|
| RISSCH4191 |
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The study was terminated because of high dropout rate.
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The purpose of this study is to evaluate the long-term treatment efficacy, and safety of risperidone long-acting injection in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center), prospective (study following participants forward in time) and observational study of risperidone long-acting injection in participants with schizophrenia. The study consists of 2 parts: Screening (that is, 28 days before study commences on Day 1) and Treatment (that is, Week 1-24). All the eligible participants (after risperidone intolerance test during screening) will be receiving risperidone as intramuscular injection (injection of a substance into a muscle) at a dose of, either 25 milligram (mg), 37.5 mg or 50 mg every two weeks. Efficacy of the participants will be primarily evaluated through Positive and Negative Syndrome Scale. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risperidone | Risperidone will be administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose will be decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may be increased or decreased at physician discretion. For first three weeks, previous oral antipsychotic drug (Benzodiazepines or Selective serotonin reuptake inhibitor [SSRI]) will be maintained and will cease at Week 3. |
| |
| Oral atypical anti-psychotic | Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc will be administered as per Investigator's discretion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risperidone | Drug | This is an observational study. Risperidone will be administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose will be decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may be increased or decreased at physician discretion. For first three weeks, previous oral antipsychotic drug (Benzodiazepines or Selective serotonin reuptake inhibitor [SSRI]) will be maintained and will cease at Week 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Personal and Social Performance (PSP) Score | The PSP is a clinician-rated scale that reflects social functioning in 4 domains of behavior (socially useful activities including work and study, personal and social relationships, self care, and disturbing and aggressive behaviors). The total score ranges from 1 to 100 (score of 71 to 100 will have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision) divided into 10 equal intervals to rate the degree of difficulty (i=absent to vi=very severe) in each of the 4 domains. |
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Inclusion Criteria:
Exclusion Criteria:
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Participant must meet the diagnostic criteria for schizophrenia or schizophreniform disorder according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
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| Name | Affiliation | Role |
|---|---|---|
| Xian-Janssen Pharmaceutical Ltd., China Clinical Trial | Xian-Janssen Pharmaceutical Ltd. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Risperidone | Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3. |
| FG001 | Oral Atypical Anti-psychotic | Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
"N" (number of participants analyzed) signifies the participants evaluable for this measure.
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| ID | Title | Description |
|---|---|---|
| BG000 | Risperidone | Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is provided for 395 participants in Risperidone treatment group because complete date of birth detail is not available for one participant. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Positive and Negative Syndrome 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. | Intent to treat (ITT) population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 24 |
|
Baseline up to Week 24
Safety population included all randomized participants who had at least baseline evaluations.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Risperidone | Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Auditory hallucination | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperlipemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical affairs director | XIAN-JANSSEN PHARMACEUTICAL | 86-10-58218307 |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
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| Oral atypical anti-psychotic | Drug | This is an observational study. Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc will be administered as per Investigator's discretion. |
|
| Baseline and Week 24 |
| Clinical Global Impressions-Severity (CGI-S) Score | The CGI-S 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 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening. | Baseline and Week 24 |
| Percentage of Participants With Relapse at Week 24 | Percentage of participants with relapse was assessed wherein relapse was defined as hospitalization due to the aggravation of psychiatric symptoms of disease condition. | Week 24 |
| Percentage of Participants Attaining Remission Criteria | Remission is defined as a clinical status where for each core symptoms (that are, delusions, conceptual disorganization, hallucinatory behavior, mannerisms and posturing unusual thought content, blunted affect, passive or apathetic social withdrawal and lack of spontaneity and flow of conversation) were assessed at a low-mild symptom intensity level, where such absent, borderline, or mild symptoms do not influence an individual's behavior. | Month 6 |
| Number of Participants With Reasons for Discontinuation From Study Treatment | Number of participants with reasons for discontinuation from study treatment is reported here because participants provided multiple reasons for discontinuation. | Month 6 |
| BG001 | Oral Atypical Anti-psychotic | Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Oral Atypical Anti-psychotic | Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion. |
|
|
| Secondary | Total Personal and Social Performance (PSP) Score | The PSP is a clinician-rated scale that reflects social functioning in 4 domains of behavior (socially useful activities including work and study, personal and social relationships, self care, and disturbing and aggressive behaviors). The total score ranges from 1 to 100 (score of 71 to 100 will have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision) divided into 10 equal intervals to rate the degree of difficulty (i=absent to vi=very severe) in each of the 4 domains. | ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 24 |
|
|
|
| Secondary | Clinical Global Impressions-Severity (CGI-S) Score | The CGI-S 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 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening. | ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Week 24 |
|
|
|
| Secondary | Percentage of Participants With Relapse at Week 24 | Percentage of participants with relapse was assessed wherein relapse was defined as hospitalization due to the aggravation of psychiatric symptoms of disease condition. | ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations. | Posted | Number | Percentage of Participants | Week 24 |
|
|
|
| Secondary | Percentage of Participants Attaining Remission Criteria | Remission is defined as a clinical status where for each core symptoms (that are, delusions, conceptual disorganization, hallucinatory behavior, mannerisms and posturing unusual thought content, blunted affect, passive or apathetic social withdrawal and lack of spontaneity and flow of conversation) were assessed at a low-mild symptom intensity level, where such absent, borderline, or mild symptoms do not influence an individual's behavior. | ITT population included all randomized participants who received at least one dose of study drug and had relevant efficacy evaluations. | Posted | Number | Percentage of Participants | Month 6 |
|
|
|
| Secondary | Number of Participants With Reasons for Discontinuation From Study Treatment | Number of participants with reasons for discontinuation from study treatment is reported here because participants provided multiple reasons for discontinuation. | Analysis population included all enrolled participants. | Posted | Number | Participants | Month 6 |
|
|
|
| 11 |
| 396 |
| 73 |
| 396 |
| EG001 | Oral Atypical Anti-psychotic | Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion. | 0 | 244 | 48 | 244 |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Nervousness | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Persecutory delusion | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
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| Abnormal behaviour | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Weight gain | Investigations | MedDRA | Non-systematic Assessment |
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| Extrapyramidal disease | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Akathisia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Somnolence | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Amenorrhea | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
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| Menstrual disorder | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Hygrostomia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
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| Lack of efficacy |
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| Discontinuation from Treatment (more than 4 weeks) |
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| Added other anti-psychotics |
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| Change to other anti-psychotics |
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| Lost to follow-up |
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| Withdrawal by participant |
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| Other (unspecified) |
|