Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia

Vanda Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: Ziprasidone; Drug: Iloperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00254202

VP-VYV-683-3101

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.

Full description

Schizophrenia is a severe mental illness affecting an estimated 1% of the world's population. Patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or emotions). Other symptoms include a reduced ability to recall and learn new information.

Iloperidone is being development as a treatment for symptoms of schizophrenia. This trial will test the safety and efficacy of iloperidone in patients with an acute exacerbation of the disease.

Enrollment: 593 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• DSM-IV diagnosis of schizophrenia
• PANSS-T of at least 70 at screening and baseline

Exclusion criteria

• Clinically significant disease of the heart, kidneys, liver or gastrointestinal system
• DSM-IV diagnosis of psychiatric disorder other than schizophrenia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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593 participants in 3 patient groups, including a placebo group

Iloperidone

Experimental group

Description:

Oral iloperidone

Treatment:

Drug: Iloperidone

Ziprasidone

Active Comparator group

Description:

Oral ziprasidone

Treatment:

Drug: Ziprasidone

Placebo

Placebo Comparator group

Description:

Oral placebo

Treatment:

Drug: Placebo