Randomized Withdrawal Study in Patients With Schizophrenia

Phase 3RecruitingNCT06961968

Vanda Pharmaceuticals400 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

400

Conditions

Schizophrenia

Interventions

iloperidoneDRUG

iloperidone LAI

placeboDRUG

matching placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (22)

Vanda Investigational Site

Rogers, Arkansas, United States

Outcomes

Primary Outcomes

Time to exacerbation of symptoms

As measured by the time to first exacerbation of psychiatric symptoms

Time frame: Up to 52 weeks post-randomization

Central Contacts

Vanda Pharmaceuticals Inc.

CONTACT

202-734-3400 clinicaltrials@vandapharma.com

Data from ClinicalTrials.gov

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