Randomized Withdrawal Study in Patients With Schizophrenia

Vanda Pharmaceuticals

Status and phase: Enrolling; Phase 3

Conditions: Schizophrenia

Treatments: Drug: placebo; 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 efficacy of dosing iloperidone long-acting injection (LAI) compared to placebo in preventing the exacerbation of symptoms in patients with schizophrenia.

Enrollment: 400 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: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 2 patient groups, including a placebo group

iloperidone

Experimental group

Description:

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.

Treatment:

Drug: iloperidone

placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo