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Label indication RISPERDAL is an atypical antipsychotic indicated for: Treatment of schizophrenia ( 1.1 ) As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ( 1.2 ) Treatment of irritability associated with autistic disorder ( 1.3 ) 1.1 Schizophrenia RISPERDAL (risperidone) is indicated for the treatment of schizophrenia. FDA label
Also known as risperidone oral tablets, Risperidone oral solution, Oral Risperidone
risperidone · 40 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.
| 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. |
| 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. |
| 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...
Top 5 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Definium Therapeutics, Inc. | DFTX | 2 | PHASE3 | DT120 |
| Vistagen Therapeutics, Inc. | VTGN | 3 | PHASE3 | Fasedienol |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | VQW-765 |
| AbbVie, Inc. | ABBV | 1 | PHASE2 | ABBV-932 |
| Psyence Biomedical Ltd. | PBM | 1 | PHASE2 | Psilocybin therapy |
Risperidone is studied in psychiatry for several conditions, including anxiety disorders, bipolar disorder, conduct disorder, attention deficit and disruptive behavior disorders, autistic disorder in children and adolescents, and pervasive developmental disorders. It is also studied in schizophrenia and schizoaffective disorder, which appear in its long-acting injectable trials.
Risperidone targets HTR2A, HTR2C, and DRD2. It acts as an antagonist at these receptors, meaning it blocks serotonin 5-HT2A and 5-HT2C receptors and dopamine D2 receptors. This receptor profile underlies its activity as a small molecule psychiatric agent.
Risperidone is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is associated with both the oral and long-acting injectable formulations of the drug.
Risperidone is in Phase 3 development. The tracked clinical program includes 19 trials, all of which are completed, with no active trials currently listed. Total enrollment across these studies is 6,152 participants.
Risperidone has been studied in completed trials including NCT01624675, a Phase 3 study of irritability associated with autistic disorder in children and adolescents in Japan, and NCT00558298, a Phase 3 long-term safety study of long-acting injectable risperidone in schizophrenia or schizoaffective disorder with 811 participants. NCT00495118 is a similar Phase 3 long-term safety study.
Risperidone is the same active drug across its formulations, which include oral tablets, oral solution, and a long-acting injectable. The oral and injectable versions differ in how they are given, and the long-acting injectable has been studied in schizophrenia and schizoaffective disorder.