Open-Label Evaluation of Relapse Prevention in Patients With Schizophrenia

Phase 3

Not yet recruiting

• Conditions: Schizophrenia
• Interventions: Drug: iloperidone

• Registration Number: NCT06961968
• Lead Sponsor: Vanda Pharmaceuticals

Brief Summary

The purpose of this research is to evaluate the relative exposure of iloperidone long-acting injection (LAI) compared to oral iloperidone in patients with schizophrenia.

Detailed Description

Not available

Study Timeline

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

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
iloperidone	iloperidone	During the 12-14 week stabilization phase, all patients will receive open-label iloperidone administered as oral tablets. Subsequently, patients meeting the criteria for LAI dosing will be enrolled into the relapse prevention phase and receive open-label iloperidone as long-acting intramuscular injections for up to 54 weeks.

Primary Outcome Measures

Name	Time	Method
Relative exposure at steady-state of iloperidone LAI compared to oral iloperidone	Up to 54 weeks	As measured by pharmacokinetic modeling