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Label indication RISPERDAL CONSTA is an atypical antipsychotic indicated: for the treatment of schizophrenia. ( 1.1 ) as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder. ( 1.2 ) 1.1 Schizophrenia RISPERDAL CONSTA (risperidone) is indicated for the treatment of schizophrenia [see Clinical Studies (14.1) ].
Also known as risperidone (RISPERDAL CONSTA), Risperidone, Risperidone long acting injectables, Risperidone Long-Acting Injection (RLAI)
Risperdal Consta · 43 trials · 31 indications
The ABC-J Irritability subscale consists of 15 items. Each item scores range from 0 to 3: 0 = No problem, 1 = Mild aberrant behavior, 2 = Moderate aberrant behavior, and 3 = Severe aberrant behavior. Higher scores represent worse condition.
The PANSS scale is used to assess the neuropsychiatric symptoms of schizophrenia. The 30-item PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items),and the general psychopathology subscale (16 items), each item rated on a scale of 1 (absent) to 7 (extreme).
Mood Relapse was defined as: The subject met DSM-IV criteria for a manic, hypomanic, mixed, or depressive episode; or, the subject needed treatment intervention with any mood stabilizer, antipsychotic medication (other than study drug), benzodiazepine (beyond the dosage allowed), or antidepressant medication; or the subject required hospitalization for any bipolar mood episode; or the subject had a YMRS or MADRS score \>12 or a CGI-S score \>4; or a dose increase, or supplementation with oral risperidone or another antipsychotic or mood stabilizer, was needed in the opinion of the investigator.
| Arm | Type | Description |
|---|---|---|
| Risperidone | EXPERIMENTAL | Subjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (\>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing \>= 45 kg was 3.0 mg. For subjects weighing \>=45 kg, the maximum daily dose was 3.0 mg. |
| Placebo | PLACEBO_COMPARATOR | Subjects will receive placebo matching with risperidone orally up to 8 weeks. |
| RISPERDAL CONSTA | ACTIVE_COMPARATOR | RISPERDAL CONSTA 25-50 mg eq every 2 weeks |
| R092670 | EXPERIMENTAL | Paliperidone Palmitate 50-150 mg eq every 4 wks |
| 001 | EXPERIMENTAL | Risperdal Consta 12.5 25 37.5 or 50mg intramuscular (IM) injection every 2 weeks |
| 002 | PLACEBO_COMPARATOR | Placebo Matching placebo intramuscular (IM) injection every 2 weeks |
| Risperidone, long-acting injectable | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Risperidone | DRUG | Subjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (\>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing \>= 45 kg was 3.0 mg. For subjects weighing \>=45 kg, the maximum daily dose was 3.0 mg. |
| Placebo | DRUG | Subjects will receive placebo matching with risperidone orally up to 8 weeks. |
| RISPERDAL CONSTA | DRUG | RISPERDAL CONSTA: Type=exact number, unit=mg, number=25, 37.5, or 50, form=suspension for injection, route=Intramuscular use. One i.m. injection of RISPERDAL CONSTA 25-50 mg eq every 2 weeks at V4, V6, V7, V8, V9, and V10. PALIPERIDONE PALMITATE PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 2 weeks at Baseline and at V4, V7, and V9. RISPERIDONE: Type=up to, unit=mg, number=1 to 6, form=Tablet, route=Oral Use. One tablet for the first 4 weeks (28 days) of the DB treatment period. |
| Paliperidone palmitate | DRUG | PALIPERIDONE PALMITATE: Type=exact number, unit=mg, number=50, 100, or 150, form=suspension for injection, route=Intramuscular use. One i.m. injection of Paliperidone palmitate 50-150 mg eq every 4 wks at Baseline, V4, V7, and V9. RISPERDAL CONSTA PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 4 weeks at Baseline, V4, V7, and V9. |
| Risperidone, long-acting injectable | DRUG | - |
| Risperidone, oral tablets | DRUG | - |
| Risperidone oral solution | DRUG | - |
| risperidone oral tablets | DRUG | - |
Inclusion Criteria: * Diagnostic for autistic disorder * A Clinical Global Impression - Severity (CGI-S) score of =\>4 and an Aberrant Behavior Checklist - Japanese Version (ABC-J) Irritability Subscale score of =\>18 * Patients with mental age of \>18 months as measured by appropriate developmenta...
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| Bristol-Myers Squibb Company | BMY | 4 | PHASE3 | Xanomeline and trospium chloride, Xanomeline/Trospium Chloride |
| AbbVie, Inc. | ABBV | 3 | PHASE3 | Cariprazine, ABBV-932, Icalcaprant |
| Xenon Pharmaceuticals Inc. | XENE | 2 | PHASE3 | Azetukalner |
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RISPERDAL CONSTA is a long-acting injectable antipsychotic used for the treatment of schizophrenia and bipolar disorder. It is a small molecule developed by Johnson & Johnson (JNJ). The drug is administered to help manage symptoms associated with these psychiatric conditions, and it has been studied in Phase 3 clinical trials.
RISPERDAL CONSTA is an antipsychotic medication that works by modulating dopamine and serotonin receptors in the brain. This mechanism helps to alleviate symptoms of schizophrenia and bipolar disorder. The drug is a small molecule formulation designed for sustained release, providing long-lasting therapeutic effects.
RISPERDAL CONSTA is developed by Johnson & Johnson, a multinational pharmaceutical company traded under the ticker JNJ. The company has conducted Phase 3 clinical trials to evaluate the drug's safety and efficacy in treating schizophrenia and bipolar disorder.
RISPERDAL CONSTA is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trials have been completed, and the drug is being studied for its effectiveness and safety in patients with schizophrenia and bipolar disorder.
RISPERDAL CONSTA has been studied in three completed Phase 3 trials. NCT00094926 and NCT00132678 evaluated the drug in bipolar disorder, while NCT00589914 compared it to paliperidone palmitate in schizophrenia. These trials enrolled a total of 1,221 participants and were randomized, double-blind, and active-controlled.
No, RISPERDAL CONSTA is not the same as paliperidone palmitate. They are distinct medications, although both are long-acting injectable antipsychotics. A Phase 3 trial (NCT00589914) directly compared the two drugs in patients with schizophrenia to evaluate their relative safety and efficacy.