Randomized Withdrawal Study in Patients With Schizophrenia
NCT ID: NCT06961968
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2025-05-14
2027-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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iloperidone
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.
iloperidone
iloperidone LAI
placebo
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.
placebo
matching placebo
Interventions
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iloperidone
iloperidone LAI
placebo
matching placebo
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with schizophrenia per DSM-5 criteria
* In need of ongoing psychiatric treatment
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Vanda Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Vanda Investigational Site
Rogers, Arkansas, United States
Vanda Investigational Site
Costa Mesa, California, United States
Vanda Investigational Site
Lemon Grove, California, United States
Vanda Investigational Site
Oceanside, California, United States
Vanda Investigational Site
Pico Rivera, California, United States
Vanda Investigational Site
San Diego, California, United States
Vanda Investigational Site
Walnut Creek, California, United States
Vanda Investigational Site
North Miami, Florida, United States
Vanda Investigational Site
Atlanta, Georgia, United States
Vanda Investigational Site
Peachtree Corners, Georgia, United States
Vanda Investigational Site
Chicago, Illinois, United States
Vanda Investigational Site
Flowood, Mississippi, United States
Vanda Investigational Site
Saint Charles, Missouri, United States
Vanda Investigational Site
St Louis, Missouri, United States
Vanda Investigational Site
Las Vegas, Nevada, United States
Vanda Investigational Site
Marlton, New Jersey, United States
Vanda Investigational Site
Staten Island, New York, United States
Vanda Investigational Site
Austin, Texas, United States
Vanda Investigational Site
Houston, Texas, United States
Vanda Investigational Site
Irving, Texas, United States
Vanda Investigational Site
Richardson, Texas, United States
Vanda Investigational Site
Bellevue, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Vanda Pharmaceuticals
Role: primary
Other Identifiers
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VP-VYV-683-3102
Identifier Type: -
Identifier Source: org_study_id
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