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The primary objective of this randomized trial was to investigate whether early initiation of treatment with Risperdal Consta after an acute episode was not inferior to the routine approach (oral treatment for 12 weeks followed by treatment with Risperdal Consta). .
Although many schizophrenia patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regiment. Long-acting injectable formulations may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. Traditionally, patients experiencing an episode of schizophrenia are first treated with oral medications until they are stabilized, and then injectable long-acting formulations are given. This is an open, multicenter, randomized Phase IV trial in patients after an acute episode of schizophrenia. Patients will be in the trial for 6 months. One treatment group will receive injections starting at baseline (early initiation); the other group will start with treatment as usual at baseline and begin injections at Week 12 (late initiation). Assessment of effectiveness include Positive And Negative Syndrome Scale (PANSS), in order to measure symptoms of schizophrenia; Clinical Global Impression - Severity (CGI-S), measuring overall severity of illness; Global Assessment of Functioning (GAF), assessesing overall psychological, social, and occupational functioning; and Quality of Life Questionnaire SF-12, measuring overall health status. Safety evaluations include the Extrapyramidal Symptoms Rating Scale (ESRS), incidence of adverse events throughout the study, and vital signs (pulse, blood pressure). The study hypothesis is that early initiation of long-acting risperidone injections is not inferior to late initiation as measured by changes in PANSS total score from baseline through endpoint (after 6 months). Risperidone, long-acting formulation for intramuscular injections (25 to 50 mg (maximum)), given every 14 days through 6 months, starting at baseline or Month 3. Treatment as usual for 3 months for late initiation group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 001 | Experimental | early initiation of treatment with Risperdal Consta 25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at baseline. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. |
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| 002 | Active Comparator | routine initiation of treatment with Risperdal Consta 25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at week 12. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| early initiation of treatment with Risperdal Consta | Drug | 25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at baseline. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint | The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme).The total score can range from 30 to 210. | at baseline and Week 26 or at premature discontinuation |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in PANSS Total Score at Week 6 | The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). The total score can range from 30 to 210. | at baseline and Week 6. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutica N.V. Clinical Trial | Janssen Pharmaceutica N.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen | Denmark | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Early Initiation of Treatment | 25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| routine initiation of treatment with Risperdal Consta | Drug | 25 mg to 50 mg Risperdal Consta intrmuscular injection every 14 days starting at week 12. Treatment with oral antipsychotics or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. |
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| Change From Baseline in PANSS Total Score at Week 12 | The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). The total score can range from 30 to 210. | at baseline and Week 12. |
| Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) | The CGI-S rating scale is used to rate the severity of a subject's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the subject's condition at a given time. | at baseline and endpoint (week 26 or at premature discontinuation). |
| Change From Baseline to Endpoint in Global Assessment of Functioning (GAF) | Overall psychological, social, and occupational functioning is rated on a scale of mental health-illness from 1 being the worst functioning to 100 being the best. Impairment in functioning due to physical (or environmental) limitations must not be included in the rating. | at baseline and endpoint (week 26 or at premature discontinuation). |
| Change From Baseline to Endpoint in Quality of Life Questionnaire SF-12 | Short Form Health Survey: A generic dual-ie, mental and physical health-scale measure of quality of life. This is a 12-item subset of the SF-36 survey that measures the same 8 domains of health. As a brief, reliable measure of overall health status, the SF-12 is the instrument of choice in large population health surveys and has been used extensively as a screening tool. SF-12 will be filled in by the patient. The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | at baseline, Weeks 6, 12, and endpoint (week 26 or at premature discontinuation). |
| Glostrup Municipality |
| Denmark |
| Hjørring | Denmark |
| Kolding | Denmark |
| Helsinki | Finland |
| Vantaa | Finland |
| Bar-le-Duc | France |
| Beaupuy | France |
| Clermont-Ferrand | France |
| Colmar | France |
| La Seyne-sur-Mer | France |
| Mont-Saint-Martin | France |
| Athens | Greece |
| Chania | Greece |
| Thessalonikis | Greece |
| Tripoli | Greece |
| Bat Yam | Israel |
| Pardesiyya | Israel |
| Petah Tikva | Israel |
| Levanger | Norway |
| Ljubljana | Slovenia |
| Danderyd | Sweden |
| Gothenburg | Sweden |
| Huddinge | Sweden |
| Stockholm | Sweden |
| Trollhättan | Sweden |
| Oetwil | Switzerland |
| Sankt Urban | Switzerland |
| Zurich | Switzerland |
| London | United Kingdom |
| Norfolk | United Kingdom |
| Late Initiation of Treatment |
routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Early Initiation of Treatment | 25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present. |
| BG001 | Late Initiation of Treatment | routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Two enrolled patients from each group were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Positive And Negative Syndrome Scale (PANSS) Total Score From Baseline to Endpoint | The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme).The total score can range from 30 to 210. | Per Protocol analysis: all randomized patients who had no violation on eligibility criteria or no major protocol violation. This excluded 42 patients in the early and 34 in the late initiation group. 1 patient in the early initiation group had no PANSS at endpoint. The endpoint is the last post-baseline value of the patient. | Posted | Mean | Standard Deviation | scores on a scale | at baseline and Week 26 or at premature discontinuation |
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| Secondary | Change From Baseline in PANSS Total Score at Week 6 | The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). The total score can range from 30 to 210. | Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group. An additional 3 and 5 patients in the respective groups had missing PANSS data at week 6. | Posted | Mean | Standard Deviation | scores on a scale | at baseline and Week 6. |
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| Secondary | Change From Baseline in PANSS Total Score at Week 12 | The PANSS is a specific scale for the measurement of the symptoms of schizophrenia. Symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme). The total score can range from 30 to 210. | Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group. An additional 9 and 23 patients in the respective groups had missing PANSS data. | Posted | Mean | Standard Deviation | scores on a scale | at baseline and Week 12. |
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| Secondary | Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) | The CGI-S rating scale is used to rate the severity of a subject's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the subject's condition at a given time. | Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.One additional patient in the Early Initiation group has missing CGI-S data. | Posted | Mean | Standard Deviation | scores on a scale | at baseline and endpoint (week 26 or at premature discontinuation). |
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| Secondary | Change From Baseline to Endpoint in Global Assessment of Functioning (GAF) | Overall psychological, social, and occupational functioning is rated on a scale of mental health-illness from 1 being the worst functioning to 100 being the best. Impairment in functioning due to physical (or environmental) limitations must not be included in the rating. | Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.One additional patient in the Early Initation group has missing GAF data. | Posted | Mean | Standard Deviation | scores on a scale | at baseline and endpoint (week 26 or at premature discontinuation). |
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| Secondary | Change From Baseline to Endpoint in Quality of Life Questionnaire SF-12 | Short Form Health Survey: A generic dual-ie, mental and physical health-scale measure of quality of life. This is a 12-item subset of the SF-36 survey that measures the same 8 domains of health. As a brief, reliable measure of overall health status, the SF-12 is the instrument of choice in large population health surveys and has been used extensively as a screening tool. SF-12 will be filled in by the patient. The scores range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. | Per protocol population. This excluded 42 patients in the early start group and 34 patients in the late start group.An additional 9 and 11 patients in the respective groups had missing SF-12 data. | Posted | Mean | Standard Deviation | scores on a scale | at baseline, Weeks 6, 12, and endpoint (week 26 or at premature discontinuation). |
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All Adverse Events (AEs) occurring between the first study-related procedure, i.e. screening visit, and week 26 or early termination were reported.
AEs described hereafter are treatment-emergent AEs, defined as AEs that were new in onset or aggravated in severity following treatment start.
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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 | Early Initiation of Treatment | 25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. | 18 | 110 | 58 | 110 | ||
| EG001 | Late Initiation of Treatment | routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. | 22 | 110 | 66 | 110 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Lower Respiratory Tract Infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
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| Drug Toxicity | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
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| Overdose | Injury, poisoning and procedural complications | MedDRA (12.0) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Extrapyramidal Disorder | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Mental Impairment | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Neuroleptic Malignant Syndrome | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Acute Psychosis | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Delusion | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Depressed Mood | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Psychiatric Symptom | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Psychotic Disorder | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Schizophrenia, Paranoid Type | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Suicidal Ideation | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Urinary Incontinence | Renal and urinary disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Epididymitis | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Erysipelas | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Self-medication | Surgical and medical procedures | MedDRA (12.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Asthenia | General disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Weight Increased | Investigations | MedDRA (12.0) | Non-systematic Assessment |
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| Akathisia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Dystonia | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Extrapyramidal Disorder | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Erectile Dysfunction | Reproductive system and breast disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Tension | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Tootache | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
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Due to the substantial number of protocol deviations (mainly due to prohibited medication), the study did not have the required power to demonstrate non-inferiority in the per protocol population
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| EMEA Medical Affairs Director Psychiatry | Janssen Cilag Spain | +34 91 7228043 |
| 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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| Non-Inferiority or Equivalence |
Non-inferiority of early initiation was inferred if the upper 95% confidence boundary for the difference of change in PANSS total score from baseline in favor of the routine approach is less than 6. |
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routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
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