Open-Label Evaluation of Relapse Prevention in Patients With Schizophrenia

Vanda Pharmaceuticals

Status and phase: Not yet enrolling; Phase 3

Conditions: Schizophrenia

Treatments: Drug: iloperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT06961968

VP-VYV-683-3102

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

iloperidone

Experimental group

Description:

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.

Treatment:

Drug: iloperidone