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

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

Completed

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Key information

Conditions

Bipolar I Disorder Mental Disorders Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vanda Investigational Site

Marlton, New Jersey, 08009, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iloperidone

Drug

Oral Tablet

Other names: FANAPT®, VYV-683

Primary outcomes

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

Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

A Safety/Tolerance Study to Evaluate a New Titration Scheme in Patients With Bipolar I Disorder or Schizophrenia

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Oct 15, 2019
Registry last updated: Apr 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed