| Study name |
A multicenter, randomized, double‐blind, placebo‐controlled study to evaluate the efficacy, safety, and tolerability of risperidone extended‐release injectable suspension (TV‐46000) for subcutaneous use as maintenance treatment in adult and adolescent patients with schizophrenia. |
| Methods |
Randomised controlled trial. |
| Participants |
Individuals diagnosed with schizophrenia, clinically stable and eligible for risperidone treatment. |
| Interventions |
Risperidone ER injectable suspension, subcutaneous injections (two different dose regimens) versus placebo. |
| Outcomes |
Efficacy, safety and tolerability outcomes (time to impending relapse, number maintaining stability, number acheiving remission, number with adverse events). |
| Starting date |
April 2018 |
| Contact information |
USMedInfo@tevapharm.com |
| Notes |
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