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
1 other identifier
interventional
400
1 country
22
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 schizophrenia
Started May 2025
Typical duration for phase_3 schizophrenia
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2025
CompletedFirst Posted
Study publicly available on registry
May 8, 2025
CompletedStudy Start
First participant enrolled
May 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
January 12, 2026
December 1, 2025
2.5 years
April 29, 2025
January 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to exacerbation of symptoms
As measured by the time to first exacerbation of psychiatric symptoms
Up to 52 weeks post-randomization
Study Arms (2)
iloperidone
EXPERIMENTALDuring 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.
placebo
PLACEBO COMPARATORDuring 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.
Interventions
Eligibility Criteria
You may qualify if:
- Males or females 18 to 65 years of age (inclusive)
- Diagnosed with schizophrenia per DSM-5 criteria
- In need of ongoing psychiatric treatment
You may not qualify if:
- DSM-5 diagnosis of a psychiatric disorder other than schizophrenia that was the primary focus of treatment within the previous six months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Vanda Investigational Site
Rogers, Arkansas, 72758, United States
Vanda Investigational Site
Costa Mesa, California, 92626, United States
Vanda Investigational Site
Lemon Grove, California, 91945, United States
Vanda Investigational Site
Oceanside, California, 92056, United States
Vanda Investigational Site
Pico Rivera, California, 90660, United States
Vanda Investigational Site
San Diego, California, 92123, United States
Vanda Investigational Site
Walnut Creek, California, 94596, United States
Vanda Investigational Site
North Miami, Florida, 33161, United States
Vanda Investigational Site
Atlanta, Georgia, 30328, United States
Vanda Investigational Site
Peachtree Corners, Georgia, 30071, United States
Vanda Investigational Site
Chicago, Illinois, 60641, United States
Vanda Investigational Site
Flowood, Mississippi, 39232, United States
Vanda Investigational Site
Saint Charles, Missouri, 63304, United States
Vanda Investigational Site
St Louis, Missouri, 63141, United States
Vanda Investigational Site
Las Vegas, Nevada, 89119, United States
Vanda Investigational Site
Marlton, New Jersey, 08053, United States
Vanda Investigational Site
Staten Island, New York, 10314, United States
Vanda Investigational Site
Austin, Texas, 78754, United States
Vanda Investigational Site
Houston, Texas, 77081, United States
Vanda Investigational Site
Irving, Texas, 75062, United States
Vanda Investigational Site
Richardson, Texas, 75080, United States
Vanda Investigational Site
Bellevue, Washington, 98007, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2025
First Posted
May 8, 2025
Study Start
May 14, 2025
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
November 1, 2027
Last Updated
January 12, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share