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

Vanda Pharmaceuticals12 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bipolar I Disorder Schizophrenia

Interventions

IloperidoneDRUG

Oral Tablet

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Vanda Investigational Site

Marlton, New Jersey, United States

Outcomes

Primary Outcomes

The frequency of treatment-emergent adverse events as measured by the number of events

Time frame: 7 days

Data from ClinicalTrials.gov

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