Randomized Withdrawal Study in Patients With Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: iloperidone, placebo.
- Who it may be relevant to
- Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Double-Blind, Randomized Withdrawal Study in Patients With Schizophrenia Receiving Either Iloperidone Long-Acting Injection (LAI) or Placebo Injection
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.
Interventions
- Drug iloperidone
iloperidone LAI - Drug placebo
matching placebo
Primary outcome measures
- Time to exacerbation of symptoms [Time frame: Up to 52 weeks post-randomization]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 22 centers
- Vanda Investigational Site — Rogers
- Vanda Investigational Site — Costa Mesa
- Vanda Investigational Site — Lemon Grove
- Vanda Investigational Site — Oceanside
- Vanda Investigational Site — Pico Rivera
- Vanda Investigational Site — San Diego
- Vanda Investigational Site — Walnut Creek
- Vanda Investigational Site — North Miami
- … and 14 more centers
Identifiers
NCT: NCT06961968 · VP-VYV-683-3102