Gaithersburg, Maryland 20877

  • Schizophrenia


This is a multicenter, open-label, adaptive, repeat-dose study to evaluate the safety, tolerability, and pharmacokinetics of iloperidone long-acting injection (LAI) in patients with schizophrenia.


Inclusion Criteria: - Willing and able to provide written informed consent. - Male or female patients 18 to 65 years of age (inclusive). - Clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorder (DSM-5) for at least 1 year. - Symptomatically stable within the past two months. Exclusion Criteria: - Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. - Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs. - Pregnant or nursing (lactating) women. - A positive test for drugs of abuse.

Study is Available At:

Original ID:




Secondary ID:

Study Acronym:

Brief Title:

A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia

Official Title:

An Open-label, Adaptive, Repeat-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Iloperidone Long-acting Injection (LAI) in Patients With Schizophrenia

Overall Status:


Study Phase:

Phase 1



Minimum Age:

18 Years

Maximum Age:

65 Years

Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Vanda Pharmaceuticals

Oversight Authority:

There was an error processing this request

Reasons Why Stopped:

Study Type:


Study Design:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Primary Contact:Vanda Pharmaceuticals Inc.

Study Dates

Start Date:January 13, 2021
Completion Date:January 2022
Completion Type:Anticipated
Primary Completion Date:January 2022
Primary Completion Type:Anticipated
Verification Date:April 2021
Last Changed Date:April 1, 2021
First Received Date:January 13, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure:Pharmacokinetics of iloperidone and its metabolites following repeat-dosing of iloperidone given as a long-acting injection.
Time Frame:24 weeks
Safety Issues:False
Description:As measured by plasma concentrations.
Outcome Type:Primary Outcome
Measure:Assessment of safety and tolerability of repeat-dosing of iloperidone given as a long-acting injection.
Time Frame:24 weeks
Safety Issues:False
Description:As measured by spontaneous reporting of adverse events (AEs).

Study Interventions

Intervention Type:Drug
Description:oral tablet, long-acting injection
Arm Name:Iloperidone
Other Name:VYV-683

Study Arms

Study Arm Type:Experimental
Arm Name:Iloperidone

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Vanda Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: September 24, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

If you would like to be contacted by the clinical trial representative please fill out the form below.