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

NCT ID: NCT04127058

Last Updated: 2020-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-07

Study Completion Date

2019-11-27

Brief Summary

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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

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Conditions

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Bipolar I Disorder Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CYP2D6 non-poor metabolizers

titrated up to 24 mg daily (12 mg b.i.d.)

Group Type OTHER

Iloperidone

Intervention Type DRUG

Oral Tablet

CYP2D6 poor metabolizers

titrated up to 12 mg daily (6 mg b.i.d.)

Group Type OTHER

Iloperidone

Intervention Type DRUG

Oral Tablet

Interventions

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Iloperidone

Oral Tablet

Intervention Type DRUG

Other Intervention Names

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FANAPTĀ® VYV-683

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanda Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Vanda Investigational Site

Marlton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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VP-VYV-683-1004

Identifier Type: -

Identifier Source: org_study_id

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