Back to resultsEvaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia
Primary Purpose
Bipolar I Disorder, Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Iloperidone
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar I Disorder
Eligibility 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
Sites / Locations
- Vanda Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
CYP2D6 non-poor metabolizers
CYP2D6 poor metabolizers
Arm Description
titrated up to 24 mg daily (12 mg b.i.d.)
titrated up to 12 mg daily (6 mg b.i.d.)
Outcomes
Primary Outcome Measures
The frequency of treatment-emergent adverse events as measured by the number of events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04127058
Brief Title
Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia
Official Title
A Safety/Tolerance Study to Evaluate a New Titration Scheme in Patients With Bipolar I Disorder or Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
November 27, 2019 (Actual)
Study Completion Date
November 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vanda Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar I Disorder, Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CYP2D6 non-poor metabolizers
Arm Type
Other
Arm Description
titrated up to 24 mg daily (12 mg b.i.d.)
Arm Title
CYP2D6 poor metabolizers
Arm Type
Other
Arm Description
titrated up to 12 mg daily (6 mg b.i.d.)
Intervention Type
Drug
Intervention Name(s)
Iloperidone
Other Intervention Name(s)
FANAPT®, VYV-683
Intervention Description
Oral Tablet
Primary Outcome Measure Information:
Title
The frequency of treatment-emergent adverse events as measured by the number of events
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Vanda Investigational Site
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia
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