Recruiting
Phase 3

Iloperidone

Sponsor:

Vanda Pharmaceuticals

Code:

NCT06961968

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

iloperidone

placebo

Study Details

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.

Conditions

Schizophrenia

Study ID

NCT06961968

Start date

May 14, 2025

Status verified date

Dec, 2025

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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.

Interventions

iloperidone

iloperidone LAI

placebo

matching placebo

Primary outcome measure

  • Time to exacerbation of symptoms [ Time Frame: Up to 52 weeks post-randomization ]

Central Contacts and Locations

Central contacts

Vanda Pharmaceuticals Inc.

202-734-3400clinicaltrials@vandapharma.com

Locations

Vanda Investigational Site

Recruiting

Rogers, Arkansas, United States, 72758

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Costa Mesa, California, United States, 92626

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Lemon Grove, California, United States, 91945

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Oceanside, California, United States, 92056

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Pico Rivera, California, United States, 90660

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

San Diego, California, United States, 92123

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Walnut Creek, California, United States, 94596

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

North Miami, Florida, United States, 33161

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Atlanta, Georgia, United States, 30328

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Peachtree Corners, Georgia, United States, 30071

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Chicago, Illinois, United States, 60641

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Flowood, Mississippi, United States, 39232

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Saint Charles, Missouri, United States, 63304

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Las Vegas, Nevada, United States, 89119

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Staten Island, New York, United States, 10314

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Austin, Texas, United States, 78754

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Houston, Texas, United States, 77081

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Irving, Texas, United States, 75062

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Richardson, Texas, United States, 75080

Contacts

Vanda Pharmaceuticals

202-734-3400

Vanda Investigational Site

Recruiting

Bellevue, Washington, United States, 98007

Contacts

Vanda Pharmaceuticals

202-734-3400

More Information

Sponsor

Vanda Pharmaceuticals

Last update posted

Jan 12, 2026

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Vanda Pharmaceuticals on 2026-01-12.