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NCT04127058 Clinical Trial

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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04127058
Other study ID # VP-VYV-683-1004
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 7, 2019
Est. completion date November 27, 2019

Study information
Verified date April 2020
Source Vanda Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date November 27, 2019
Est. primary completion date November 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Iloperidone
Oral Tablet

Locations
Country Name City State
United States Vanda Investigational Site Marlton New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Vanda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The frequency of treatment-emergent adverse events as measured by the number of events 7 days
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