Randomized Withdrawal Study in Patients With Schizophrenia

Phase 3

Recruiting

• Conditions: Schizophrenia
• Interventions: Drug: iloperidone; Drug: placebo

• Registration Number: NCT06961968
• Lead Sponsor: Vanda Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-29
• Study First Submitted QC: 2025-04-29
• Study First Posted: 2025-05-08
• Study Start: 2025-05-14
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-05
• Last Update Posted: 2025-09-12
• Primary Completion: 2027-11
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Males or females 18 to 65 years of age (inclusive)
• Diagnosed with schizophrenia per DSM-5 criteria
• In need of ongoing psychiatric treatment

Exclusion Criteria

• DSM-5 diagnosis of a psychiatric disorder other than schizophrenia that was the primary focus of treatment within the previous six months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iloperidone	iloperidone	During the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (iloperidone long-acting injection) as long-acting intramuscular injections for up to 52 weeks.
placebo	placebo	During the 12-week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets (weeks 1-6) and as long-acting intramuscular injections (weeks 7-12). Subsequently, patients will be randomized in a 1:1 ratio to one of two arms: iloperidone long-acting injection or matching placebo. Post-randomization this arm will receive double-blind study drug (matching placebo) as long-acting intramuscular injections for up to 52 weeks.

Primary Outcome Measures

Name	Time	Method
Time to exacerbation of symptoms	Up to 52 weeks post-randomization	As measured by the time to first exacerbation of psychiatric symptoms

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Richardson, Texas, United States