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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04127058
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Schizophrenia Drug: Iloperidone Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety/Tolerance Study to Evaluate a New Titration Scheme in Patients With Bipolar I Disorder or Schizophrenia
Actual Study Start Date : October 7, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Iloperidone

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

CYP2D6 poor metabolizers
titrated up to 12 mg daily (6 mg b.i.d.)
Drug: Iloperidone
Oral Tablet
Other Names:
  • FANAPT®
  • VYV-683




Primary Outcome Measures :
  1. The frequency of treatment-emergent adverse events as measured by the number of events [ Time Frame: 7 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04127058


Contacts
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Contact: Vanda Pharmaceuticals 202-734-3400 clinicaltrials@vandapharma.com

Locations
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United States, New Jersey
Vanda Investigational Site Recruiting
Marlton, New Jersey, United States, 08009
Contact: Vanda Pharmaceuticals    202-734-3400      
Sponsors and Collaborators
Vanda Pharmaceuticals

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Responsible Party: Vanda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04127058    
Other Study ID Numbers: VP-VYV-683-1004
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Iloperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs