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| ID | Type | Description | Link |
|---|---|---|---|
| RISSCH4060 | Other Identifier | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. |
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| Name | Class |
|---|---|
| Janssen, LP | INDUSTRY |
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The purpose of this study is to compare the effectiveness of two antipsychotic medications, Risperdal® Consta® versus Abilify®, over a 2-year treatment period in the long-term maintenance of patients with schizophrenia.
Although many patients with schizophrenia currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to the daily oral regimen. Long-acting injectable formulations of antipsychotics may eliminate the need for daily medication and enhance patient compliance with the treatment regimen. The purpose of this trial is to evaluate the long-term effectiveness of Risperdal® Consta®, a long-acting injectable antipsychotic medication, versus Abilify®, an oral antipsychotic medication in patients with schizophrenia. The study will include patients, who in the investigator's opinion may benefit from a change in their current antipsychotic medication due to insufficient effectiveness, side effects or difficulty in adhering to a daily dose regimen. This is an open-label, randomized study in which patients will have an equal chance of receiving treatment for up to 2 years with Risperdal® Consta®, administered in the muscles near the hip every 2 weeks, or Abilify®, taken orally once daily. The initial dose and subsequent dose of study drug will be determined by the investigator. The patient's current oral antipsychotic medication will be decreased over the first four weeks of the study and discontinued. During the study, investigators may adjust the dose of study drug or add new antipsychotic medications to treat worsening psychotic symptoms. Patients may continue on or have added, antidepressants, mood stabilizers (except carbamazepine), sedative hypnotics, or anxiolytic medications during the study. Patients will return to the doctor's office every two weeks to receive an injection of Risperdal® Consta® or another supply of Abilify®. During certain visits, patients will be asked questions which will help the investigator determine the severity of the patient's illness, how well the study drug is working, quality of life, reasoning, memory, judgement and perception and side effects that may be associated with schizophrenia or treatment. Safety evaluations include the incidence of adverse events during the study, vital signs and clinical laboratory tests (both blood and urine). The study hypothesis is that Risperdal® Consta® is superior to Abilify® in the long-term treatment of subjects with schizophrenia as measured by time to relapse and time in remission. Treatment with Risperdal® Consta® (administered in the muscle every 2 weeks) at a dose of 25, 37.5 or 50 mg or Abilify® (administered orally daily) at a dose of 10-30 mg for 2 years. Investigators will determine the starting dose and may adjust the dosage of study drug during the study according to symptoms and treatment response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 002 | Active Comparator |
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| 001 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abilify | Drug | 10-30 mg once daily for 104 weeks |
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| Risperidal Consta |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Relapse | Time to relapse was defined as the number of days from the date of first dose to the date of relapse, as determined by the Relapse Monitoring Board. | Day 1 to relapse |
| Time in Remission | Time in remission for an individual subject was defined as the length of time (in days) that the remission criteria were maintained during the trial. Remission was defined as the simultaneous attainment of a score of 3 (mild), 2 (minimal), or 1 (absent) for all the following individual items from Positive and Negative Syndrome Scale (PANSS): delusions (P1), concept disorganization (P2), hallucinatory behavior (P3), unusual thought content (G9), mannerisms and posturing (G5), blunted affect (N1), passive/apathetic social withdrawal (N4), and lack of spontaneity and flow of conversation (N6). | Day 1 to last PANSS measurement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Study Director |
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A Screening Visit (maximum of 14 days) prior to the Treatment Phase. Baseline included psychiatric exam, lab, ECG, and schizophrenia symptom rating scale. Subjects were permitted to remain on previous psychotropic medications (i.e., antipsychotic, antidepressant, mood stabilizer, anxiolytics) up to the first 4 weeks of the Treatment Phase.
The first patient in was on February 28, 2006; last patient out was on January 26, 2009. Enrollment occurred across multiple sites in the United States, Argentina, Chile, and India and patients were enrolled from outpatient psychiatric clinics associated with private medical practices, private clinical trial sites, and academic medical centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Risperdal Consta | 25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks |
| FG001 | Abilify | 10-30 mg once daily oral for 104 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
25mg, 37.5mg, or 50mg every 2 weeks for 104 weeks |
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| ID | Title | Description |
|---|---|---|
| BG000 | Risperdal Consta | 25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks |
| BG001 | Abilify | 10-30 mg once daily oral for 104 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | 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 | Time to Relapse | Time to relapse was defined as the number of days from the date of first dose to the date of relapse, as determined by the Relapse Monitoring Board. | explanatory ITT analysis data set (eITT) contains all subjects who had at least one administration of study drug as well as at least one follow-up efficacy measurement; includes assessments while the subject is on study drug. | Posted | Median | 95% Confidence Interval | days | Day 1 to relapse |
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| Primary | Time in Remission | Time in remission for an individual subject was defined as the length of time (in days) that the remission criteria were maintained during the trial. Remission was defined as the simultaneous attainment of a score of 3 (mild), 2 (minimal), or 1 (absent) for all the following individual items from Positive and Negative Syndrome Scale (PANSS): delusions (P1), concept disorganization (P2), hallucinatory behavior (P3), unusual thought content (G9), mannerisms and posturing (G5), blunted affect (N1), passive/apathetic social withdrawal (N4), and lack of spontaneity and flow of conversation (N6). | explanatory ITT analysis data set (eITT) contains all subjects who had at least one administration of study drug as well as at least one follow-up efficacy measurement; includes assessments while the subject is on study drug. | Posted | Mean | Standard Deviation | days | Day 1 to last PANSS measurement |
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Adverse events were reported as treatment emergent if the onset date is before or within 49 days of last dose of RISPERDAL CONSTA or before or within 30 days of last dose of Abilify.
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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 | RISPERDAL CONSTA | 25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks | 31 | 179 | 151 | 179 | ||
| EG001 | Abilify | 10-30 mg once daily oral for 104 weeks | 35 | 176 | 141 | 176 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 10 | Non-systematic Assessment |
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| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA 10 | Non-systematic Assessment |
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| CARDIO-RESPIRATORY ARREST | Cardiac disorders | MedDRA 10 | Non-systematic Assessment |
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| GOITRE | Endocrine disorders | MedDRA 10 | Non-systematic Assessment |
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| ANAL FISSURE | Gastrointestinal disorders | MedDRA 10 | Non-systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 10 | Non-systematic Assessment |
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| IRRITABLE BOWEL SYNDROME | Gastrointestinal disorders | MedDRA 10 | Non-systematic Assessment |
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| MELAENA | Gastrointestinal disorders | MedDRA 10 | Non-systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 10 | Non-systematic Assessment |
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| DEATH | General disorders | MedDRA 10 | Non-systematic Assessment |
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| PYREXIA | General disorders | MedDRA 10 | Non-systematic Assessment |
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| CELLULITIS | Infections and infestations | MedDRA 10 | Non-systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 10 | Non-systematic Assessment |
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| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 10 | Non-systematic Assessment |
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| JOINT DISLOCATION | Injury, poisoning and procedural complications | MedDRA 10 | Non-systematic Assessment |
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| MULTIPLE DRUG OVERDOSE ACCIDENTAL | Injury, poisoning and procedural complications | MedDRA 10 | Non-systematic Assessment |
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| ROAD TRAFFIC ACCIDENT | Injury, poisoning and procedural complications | MedDRA 10 | Non-systematic Assessment |
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| DEHYDRATION | Metabolism and nutrition disorders | MedDRA 10 | Non-systematic Assessment |
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| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA 10 | Non-systematic Assessment |
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| ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 10 | Non-systematic Assessment |
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| LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10 | Non-systematic Assessment |
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| AKATHISIA | Nervous system disorders | MedDRA 10 | Non-systematic Assessment |
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| CONVULSION | Nervous system disorders | MedDRA 10 | Non-systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA 10 | Non-systematic Assessment |
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| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| SCHIZOPHRENIA | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| AGGRESSION | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| DEPRESSION SUICIDAL | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| AFFECT LABILITY | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| ALCOHOLISM | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| COMPLETED SUICIDE | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| DRUG DEPENDENCE | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| HOMICIDAL IDEATION | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| MANIA | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| MENTAL STATUS CHANGES | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Non-systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HYPERPROLACTINAEMIA | Endocrine disorders | MedDRA 10 | Non-systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 10 | Non-systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 10 | Non-systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 10 | Non-systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 10 | Non-systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 10 | Non-systematic Assessment |
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| SALIVARY HYPERSECRETION | Gastrointestinal disorders | MedDRA 10 | Non-systematic Assessment |
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| PYREXIA | General disorders | MedDRA 10 | Non-systematic Assessment |
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| FATIGUE | General disorders | MedDRA 10 | Non-systematic Assessment |
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| ASTHENIA | General disorders | MedDRA 10 | Non-systematic Assessment |
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| INJECTION SITE PAIN | General disorders | MedDRA 10 | Non-systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 10 | Non-systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 10 | Non-systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 10 | Non-systematic Assessment |
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| WEIGHT INCREASED | Investigations | MedDRA 10 | Non-systematic Assessment |
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| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 10 | Non-systematic Assessment |
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| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 10 | Non-systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 10 | Non-systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 10 | Non-systematic Assessment |
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| TREMOR | Nervous system disorders | MedDRA 10 | Non-systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 10 | Non-systematic Assessment |
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| AKATHISIA | Nervous system disorders | MedDRA 10 | Non-systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 10 | Non-systematic Assessment |
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| HYPERSOMNIA | Nervous system disorders | MedDRA 10 | Non-systematic Assessment |
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| SOMNOLENCE | Nervous system disorders | MedDRA 10 | Non-systematic Assessment |
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| SEDATION | Nervous system disorders | MedDRA 10 | Non-systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| PSYCHOTIC DISORDER | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| ANXIETY | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| SCHIZOPHRENIA | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| RESTLESSNESS | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| SLEEP DISORDER | Psychiatric disorders | MedDRA 10 | Non-systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 10 | Non-systematic Assessment |
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15% of subjects did not meet stability inclusion criteria; many received supplemental antipsychotics post-randomization; biweekly visits may have increased aripiprazole adherence; numerous early dropouts may have led to dependent censoring and bias.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Lead | Ortho-McNeil, Inc. N America Pharm CNS/IM | 609-730-3693 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068180 | Aripiprazole |
| D018967 | Risperidone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
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| >=65 years |
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| Male |
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| United States |
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| South America |
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