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Randomized Withdrawal Study in Patients With Schizophrenia

StatusRecruiting
PhasePhase 3
Started2025-05-14
View on ClinicalTrials.gov ↗

Amendment history

2026-01-09
Study Status, Oversight, Contacts/Locations v2
Study sites2→22
2025-09-05
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-05→confirmed 2025-05-14
Enrollment target200→400
Study sites0→2
Study arms1→2
Interventionsiloperidone (Drug)→iloperidone (Drug), placebo (Drug)
Primary endpoints1 entry, revised
RelativeTime exposureto at steady-stateexacerbation of iloperidone LAI compared to oral iloperidonesymptoms
Study title-16 characters
Open-LabelRandomized EvaluationWithdrawal of Relapse PreventionStudy in Patients With Schizophrenia
2025-04-29
Original filing
The purpose of this research is to evaluate the efficacy of dosing iloperidone long-acting injection (LAI) compared to placebo in preventing the exacerbation of symptoms in patients with schizophrenia.
Trial Details
NCT Number NCT06961968
Lead Sponsor Vanda Pharmaceuticals
Conditions Schizophrenia
Enrollment 400 participants
Start Date 2025-05-14
Primary Completion 2027-11 (estimated)
Study Completion 2027-11 (estimated)
Updated on ClinicalTrials.gov 2026-01-12