Phase 3 Study of NBI-1117568 to Prevent Schizophrenia Relapse in Adults Double-Blind, Placebo-Controlled Randomized Withdrawal Trial

What this Trial Is About

Researchers are evaluating the drug NBI-1117568 in adults with schizophrenia to see if it can delay the return of symptoms after a stable response to initial treatment. This phase 3 study compares NBI-1117568 with a placebo in a randomized, double-blind format to assess both its effectiveness and safety. The trial is sponsored by Neurocrine Biosciences and focuses on adults aged 18 to 65 years who have been diagnosed with schizophrenia for at least one year and have previously responded to antipsychotic therapy other than clozapine. All participants first receive NBI-1117568 during an open-label stabilization period to achieve symptom control. After this, participants are randomly assigned to continue with either NBI-1117568 or a placebo during the double-blind treatment period, which lasts up to approximately 30 weeks. Both treatments are given as oral capsules, and the study uses a quadruple-blind design to ensure unbiased results. Participants will be closely monitored throughout the study for symptom relapse, with the primary outcome measuring the time from randomization to relapse. Assessments include psychiatric evaluations and safety checks to monitor tolerability of the drug. The total participation duration includes the stabilization phase and the double-blind treatment period, providing detailed information on the drugs ability to maintain symptom stability in schizophrenia over time.

Efficacy of NBI-1117568 in Preventing Relapse in Adults With Schizophrenia