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| ID | Type | Description | Link |
|---|---|---|---|
| RISSCH4135 |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 2, 4, 8, 16, 24, 38 and 50 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Ltd. Clinical trial | Janssen-Cilag Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Curitiba | Brazil | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Risperidone Prolonged Release | Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Risperidone Prolonged Release | Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased 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 | Mean |
| 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 | 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. | Intent-to-treat-efficacy evaluation (ITTe) population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy. | Posted | Mean | Standard Error | Units on a scale | Week 2 |
|
Baseline up to Week 50
Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use.
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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 Prolonged Release | Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychomotor hyperactivity | Nervous system disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperprolactinaemia | Endocrine disorders | MedDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Group Manager | Janssen-Cilag Ltd. | +55 11 30302738 |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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Not provided
| ID | Term |
|---|---|
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| 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 |
| 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). | Baseline and Week 2, 4, 8, 16, 24 and 50 |
| 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). | Screening, and Week 8, 24 and 50 |
| 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. | Baseline and Week 50 |
| 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.](streamdown:incomplete-link) | Screening, and Week 8, 16, 24, 38 and 50 |
| 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. | Screening, and Week 8, 16, 24, 38 and 50 |
| Porto Alegre |
| Brazil |
| Rio de Janeiro | Brazil |
| Salvador | Brazil |
| São Paulo | Brazil |
| Lost to Follow-up |
|
| Exacerbation of psychotic symptoms |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Positive and Negative Syndromes Scale (PANSS) Total Score | 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. | Mean | Standard Deviation | Units on a scale |
|
|
|
| Primary | 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. | The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy. | Posted | Mean | Standard Error | Units on a scale | Week 4 |
|
|
|
| Primary | 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. | The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy. | Posted | Mean | Standard Error | Units on a scale | Week 8 |
|
|
|
| Primary | 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. | The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy. | Posted | Mean | Standard Error | Units on a scale | Week 16 |
|
|
|
| Primary | 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. | The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy. | Posted | Mean | Standard Error | Units on a scale | Week 24 |
|
|
|
| Secondary | 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. | The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy. | Posted | Mean | Standard Error | Units on a scale | Baseline and Week 2, 4, 8, 16, 24, 38 and 50 |
|
|
|
| Secondary | 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). | Intent-to-treat-safety evaluation (ITTs) population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Error | Units on a scale | Baseline and Week 2, 4, 8, 16, 24 and 50 |
|
|
|
| Secondary | 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). | ITTs population included all the Participants who received at least one dose of study medication and were reassessed after the start of use. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Error | Units on a scale | Screening, and Week 8, 24 and 50 |
|
|
|
| Secondary | 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. | The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 50 |
|
|
|
| Primary | 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. | The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy. | Posted | Mean | Standard Error | Units on a scale | Week 38 |
|
|
|
| Primary | 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. | The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy. | Posted | Mean | Standard Error | Units on a scale | Week 50 |
|
|
|
| Secondary | 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.](streamdown:incomplete-link) | The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy. | Posted | Mean | Standard Error | Units on a scale | Screening, and Week 8, 16, 24, 38 and 50 |
|
|
|
| Secondary | 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. | The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy. | Posted | Mean | Standard Error | Units on a scale | Screening, and Week 8, 16, 24, 38 and 50 |
|
|
|
| 3 |
| 53 |
| 40 |
| 53 |
| Psychotic disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Application site pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
|
| Feeling jittery | General disorders | MedDRA | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA | Non-systematic Assessment |
|
| Hypersensitivity | Immune system disorders | MedDRA | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood prolactin increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Blood thyroid stimulating hormone increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Increased appetite | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Dystonia | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Abnormal behaviour | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Apathy | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Fear | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Hostility | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Libido decreased | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Orgasm abnormal | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Psychotic disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Schizophrenia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Schizophrenia, disorganised type | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Galactorrhoea | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
|
The only disclosure restriction on the Principal Investigator is that the Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the Sponsor for review. The Sponsor can require changes to the communication and can extend the embargo.
| Title | Measurements |
|---|---|
|
| Week 8 |
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| Week 16 |
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| Week 24 |
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| Week 38 |
|
| Week 50 |
|
| Title | Measurements |
|---|---|
|
| Week 8 |
|
| Week 16 |
|
| Week 24 |
|
| Week 50 |
|
| Title | Measurements |
|---|---|
|
| Week 50 |
|
| Title | Measurements |
|---|---|
|
| Health General State : Baseline |
|
| Vitality : Baseline |
|
| Social Aspect : Baseline |
|
| Emotional Aspect : Baseline |
|
| Mental Health : Baseline |
|
| Functional capacity : Week 50 |
|
| Physical aspect : Week 50 |
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| Pain : Week 50 |
|
| Health General State : Week 50 |
|
| Vitality : Week 50 |
|
| Social Aspect : Week 50 |
|
| Emotional Aspect : Week 50 |
|
| Mental Health : Week 50 |
|
| Title | Measurements |
|---|---|
|
| Week 24 |
|
| Week 38 |
|
| Week 50 |
|
| Title | Measurements |
|---|---|
|
| Week 24 |
|
| Week 38 |
|
| Week 50 |
|