Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia

Vanda Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Schizophrenia; Bipolar I Disorder

Treatments: Drug: Iloperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT04127058

VP-VYV-683-1004

Details and patient eligibility

About

This is a single-center open-label study to be conducted in the United States in subjects with bipolar I disorder or schizophrenia.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients 18 to 65 years of age (inclusive)
• Diagnosed with either schizophrenia or bipolar I disorder, manic or mixed type as per DSM-V criteria
• Symptomatically stable within the past two months

Exclusion criteria

• Exposure to any investigational medication, including placebo, in the past 60 days
• Non-response to clozapine

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

CYP2D6 non-poor metabolizers

Other group

Description:

titrated up to 24 mg daily (12 mg b.i.d.)

Treatment:

Drug: Iloperidone

CYP2D6 poor metabolizers

Other group

Description:

titrated up to 12 mg daily (6 mg b.i.d.)

Treatment:

Drug: Iloperidone