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

April 9, 2020 updated by: Vanda Pharmaceuticals

A Safety/Tolerance Study to Evaluate a New Titration Scheme in Patients With 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Marlton, New Jersey, United States, 08009
        • Vanda Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CYP2D6 non-poor metabolizers
titrated up to 24 mg daily (12 mg b.i.d.)
Drug: Iloperidone
Oral Tablet
Other Names:
  • VYV-683
  • FANAPT®
Other: CYP2D6 poor metabolizers
titrated up to 12 mg daily (6 mg b.i.d.)
Drug: Iloperidone
Oral Tablet
Other Names:
  • VYV-683
  • FANAPT®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The frequency of treatment-emergent adverse events as measured by the number of events
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 7, 2019

Primary Completion (Actual)

November 27, 2019

Study Completion (Actual)

November 27, 2019

Study Registration Dates

First Submitted

October 7, 2019

First Submitted That Met QC Criteria

October 11, 2019

First Posted (Actual)

October 15, 2019

Study Record Updates

Last Update Posted (Actual)

April 13, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VYV-683-1004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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