Randomized Withdrawal Study in Patients With Schizophrenia

A Multicenter, Double-Blind, Randomized Withdrawal Study in Patients With Schizophrenia Receiving Either Iloperidone Long-Acting Injection (LAI) or Placebo Injection

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06961968

Enrollment

400

Registered

2025-05-08

Start date

2025-05-14

Completion date

2027-11-30

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Antipsychotic Agents, Iloperidone, Long-Acting Injection, Randomized Withdrawal

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.

Interventions

DRUGiloperidone

iloperidone LAI

DRUGplacebo

matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Time to exacerbation of symptoms	Up to 52 weeks post-randomization	As measured by the time to first exacerbation of psychiatric symptoms

Countries

United States

Contacts

Primary ContactVanda Pharmaceuticals Inc.

clinicaltrials@vandapharma.com202-734-3400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026