Switching to Iloperidone From Other Antipsychotics in Schizophrenia (i-FANS)

Novartis

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: iloperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT01207414

CILO522DUS01

Details and patient eligibility

About

Evaluate the clinical outcome of two switching strategies to iloperidone treatment in adult subjects with schizophrenia who require a change in their current antipsychotic treatment of risperidone, olanzapine, or aripiprazole due to suboptimal efficacy and/or safety/tolerability reasons.

Enrollment: 501 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males or females, 18 to 64 years of age, inclusive
• DSM-IV diagnosis of schizophrenia
• Patients currently on an optimal in-label dose of one of the following permitted antipsychotic treatments for at least 30 days: risperidone, olanzapine, or aripiprazole
• Efficacy Clinical Global Impression of Severity (E-CGI-S) of 4 or 5 or
• Not tolerating one of the permitted treatments and exhibits one of the allowable side-effects

Exclusion criteria

• Any other current Axis I disorder other than schizophrenia which is the focus of treatment;
• Acutely psychotic or patient's symptom severity requires hospitalization
• Patient with significant cardiovascular illness (myocardial infarction, cardiac arrhythmia)

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

501 participants in 2 patient groups

iloperidone gradual switch

Experimental group

Description:

Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week. On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks.

Treatment:

Drug: iloperidone

iloperidone immediate switch

Experimental group

Description:

Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately. On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks.

Treatment:

Drug: iloperidone