Randomized Withdrawal Study in Patients With Schizophrenia

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT06961968

Run by

Vanda Pharmaceuticals

People needed

400

Starts

2025-05-14

Expected to finish

2027-11-01

Last updated by the study team

2026-01-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Vanda Investigational Site — Rogers, Arkansas, United States (enrolling)
• Vanda Investigational Site — Costa Mesa, California, United States (enrolling)
• Vanda Investigational Site — Lemon Grove, California, United States (enrolling)
• Vanda Investigational Site — Oceanside, California, United States (enrolling)
• Vanda Investigational Site — Pico Rivera, California, United States (enrolling)
• Vanda Investigational Site — San Diego, California, United States (enrolling)
• Vanda Investigational Site — Walnut Creek, California, United States (enrolling)
• Vanda Investigational Site — North Miami, Florida, United States (enrolling)
• Vanda Investigational Site — Atlanta, Georgia, United States (enrolling)
• Vanda Investigational Site — Peachtree Corners, Georgia, United States (enrolling)
• Vanda Investigational Site — Chicago, Illinois, United States (enrolling)
• Vanda Investigational Site — Flowood, Mississippi, United States (enrolling)
• Vanda Investigational Site — Saint Charles, Missouri, United States (enrolling)
• Vanda Investigational Site — St Louis, Missouri, United States (enrolling)
• Vanda Investigational Site — Las Vegas, Nevada, United States (enrolling)
• Vanda Investigational Site — Marlton, New Jersey, United States (enrolling)
• Vanda Investigational Site — Staten Island, New York, United States (enrolling)
• Vanda Investigational Site — Austin, Texas, United States (enrolling)
• Vanda Investigational Site — Houston, Texas, United States (enrolling)
• Vanda Investigational Site — Irving, Texas, United States (enrolling)
• Vanda Investigational Site — Richardson, Texas, United States (enrolling)
• Vanda Investigational Site — Bellevue, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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