Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia
A Safety/Tolerance Study to Evaluate a New Titration Scheme in Patients With Bipolar I Disorder or Schizophrenia
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2019
CompletedStudy Start
First participant enrolled
October 7, 2019
CompletedFirst Posted
Study publicly available on registry
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2019
CompletedApril 13, 2020
April 1, 2020
2 months
October 7, 2019
April 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
The frequency of treatment-emergent adverse events as measured by the number of events
7 days
Study Arms (2)
CYP2D6 non-poor metabolizers
OTHERtitrated up to 24 mg daily (12 mg b.i.d.)
CYP2D6 poor metabolizers
OTHERtitrated up to 12 mg daily (6 mg b.i.d.)
Interventions
Oral Tablet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Exposure to any investigational medication, including placebo, in the past 60 days
- Non-response to clozapine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanda Investigational Site
Marlton, New Jersey, 08009, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2019
First Posted
October 15, 2019
Study Start
October 7, 2019
Primary Completion
November 27, 2019
Study Completion
November 27, 2019
Last Updated
April 13, 2020
Record last verified: 2020-04