Randomized Withdrawal Study in Patients With Schizophrenia

Conditions

• Schizophrenia

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• iloperidone — DRUG
  iloperidone LAI
• placebo — DRUG
  matching placebo

Study Details

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 Dates

Start date

May 14, 2025

Status verified

Dec 2025

Primary completion

Nov 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Vanda Pharmaceuticals Inc.
  202-734-3400
  [email protected]

Locations (22)

Find similar trials in Rogers, AR

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