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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04127058

Enrollment

Registered

2019-10-15

Start date

2019-10-07

Completion date

2019-11-27

Last updated

2020-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar I Disorder, Schizophrenia

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.

Interventions

DRUGIloperidone

Oral Tablet

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026