Evaluating a New Iloperidone Titration Scheme in Bipolar... | NCT04127058

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

NCT04127058

Sponsor

Vanda Pharmaceuticals

Status

Completed

Last Update Posted

Apr 13, 2020Actual

Enrollment

12Actual

Phase

Phase 1

Conditions

Bipolar I Disorder
Schizophrenia

Interventions

Iloperidone

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 7, 2019Actual

Primary Completion Date

Nov 27, 2019Actual

Completion Date

Nov 27, 2019Actual

First Submitted Date

Oct 7, 2019

First Submission Date that Met QC Criteria

Oct 11, 2019

First Posted Date

Oct 15, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2020

Last Update Posted Date

Apr 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CYP2D6 non-poor metabolizers	Other	titrated up to 24 mg daily (12 mg b.i.d.)	Drug: Iloperidone
CYP2D6 poor metabolizers	Other	titrated up to 12 mg daily (6 mg b.i.d.)	Drug: Iloperidone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iloperidone	Drug	Oral Tablet	CYP2D6 non-poor metabolizers CYP2D6 poor metabolizers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The frequency of treatment-emergent adverse events as measured by the number of events		7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vanda Investigational Site		Marlton	New Jersey	08009	United States

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C081732	iloperidone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided