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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

Tracking Information
First Submitted Date  ICMJE October 7, 2019
First Posted Date  ICMJE October 15, 2019
Last Update Posted Date October 15, 2019
Actual Study Start Date  ICMJE October 7, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2019)
The frequency of treatment-emergent adverse events as measured by the number of events [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia
Official Title  ICMJE A Safety/Tolerance Study to Evaluate a New Titration Scheme in Patients With Bipolar I Disorder or Schizophrenia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bipolar I Disorder
  • Schizophrenia
Intervention  ICMJE Drug: Iloperidone
Oral Tablet
Other Names:
  • FANAPT®
  • VYV-683
Study Arms  ICMJE
  • CYP2D6 non-poor metabolizers
    titrated up to 24 mg daily (12 mg b.i.d.)
    Intervention: Drug: Iloperidone
  • CYP2D6 poor metabolizers
    titrated up to 12 mg daily (6 mg b.i.d.)
    Intervention: Drug: Iloperidone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 11, 2019)
14
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2019
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vanda Pharmaceuticals 202-734-3400 clinicaltrials@vandapharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04127058
Other Study ID Numbers  ICMJE VP-VYV-683-1004
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vanda Pharmaceuticals
Study Sponsor  ICMJE Vanda Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vanda Pharmaceuticals
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP