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

Phase 1

Completed

• Conditions: Bipolar I Disorder; Schizophrenia
• Interventions: Drug: Iloperidone

• Registration Number: NCT04127058
• Lead Sponsor: Vanda Pharmaceuticals

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 available

Study Timeline

• Study Start: 2019-10-07
• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-15
• Primary Completion: 2019-11-27
• Study Completion: 2019-11-27
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-09
• Last Update Posted: 2020-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CYP2D6 non-poor metabolizers	Iloperidone	titrated up to 24 mg daily (12 mg b.i.d.)
CYP2D6 poor metabolizers	Iloperidone	titrated up to 12 mg daily (6 mg b.i.d.)

Primary Outcome Measures

Name	Time	Method
The frequency of treatment-emergent adverse events as measured by the number of events	7 days

Trial Locations

Locations (1)

Vanda Investigational Site; 🇺🇸 Marlton, New Jersey, United States