NCT04819776

Brief Summary

The aim of this study is to investigate the efficacy, safety, and tolerability of iloperidone compared with placebo in treating acute manic or mixed episodes associated with Bipolar I Disorder.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
417

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2021

Geographic Reach
3 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2023

Completed
8 months until next milestone

Results Posted

Study results publicly available

April 16, 2024

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

1.5 years

First QC Date

March 24, 2021

Results QC Date

March 19, 2024

Last Update Submit

April 16, 2024

Conditions

Bipolar I Disorder

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score

    The Young Mania Rating Scale (YMRS) is an 11-item scale. Individual item scores are summed for a total possible score of 0 (best) to 60 (worst).

    Week 4

Study Arms (2)

Iloperidone

EXPERIMENTAL
Drug: Iloperidone

Placebo

PLACEBO COMPARATOR
Drug: Iloperidone Placebo

Interventions

IloperidoneDRUG

Oral iloperidone

Also known as: FANAPT®, VYV-683
Iloperidone
Iloperidone PlaceboDRUG

Oral placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients 18 to 65 years of age (inclusive)
  • Diagnosed with bipolar I disorder, manic or mixed-type, per DSM-5 criteria
  • Voluntary hospitalization for current manic episode

You may not qualify if:

  • Patients with a DSM-5 diagnosis of a psychiatric disorder other than bipolar I disorder that was the primary focus of treatment within the previous six months
  • Patients who are experiencing a first manic episode or meeting criteria for rapid cycling

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Vanda Investigational Site

Little Rock, Arkansas, 72211, United States

Location

Vanda Investigational Site

Rogers, Arkansas, 72758, United States

Location

Vanda Investigational Site

Cerritos, California, 90703, United States

Location

Vanda Investigational Site

Culver City, California, 90230, United States

Location

Vanda Investigational Site

Long Beach, California, 90806, United States

Location

Vanda Investigational Site

Orange, California, 92868, United States

Location

Vanda Investigational Site

Torrance, California, 90502, United States

Location

Vanda Investigational Site

Miami Lakes, Florida, 33016, United States

Location

Vanda Investigational Site

Oakland Park, Florida, 33334, United States

Location

Vanda Investigational Site

Atlanta, Georgia, 30331, United States

Location

Vanda Investigational Site

Decatur, Georgia, 30030, United States

Location

Vanda Investigational Site

Gaithersburg, Maryland, 20877, United States

Location

Vanda Investigational Site

Flowood, Mississippi, 39232, United States

Location

Vanda Investigational Site

Las Vegas, Nevada, 89102, United States

Location

Vanda Investigational Site

Marlton, New Jersey, 08053, United States

Location

Vanda Investigational Site

Dayton, Ohio, 45417, United States

Location

Vanda Investigational Site

North Canton, Ohio, 44720, United States

Location

Vanda Investigational Site

Austin, Texas, 78754, United States

Location

Vanda Investigational Site

DeSoto, Texas, 75115, United States

Location

Vanda Investigational Site

Richardson, Texas, 75080, United States

Location

Vanda Investigational Site

Novi Iskar, Sofia-Grad, 1282, Bulgaria

Location

Vanda Investigational Site

Tserova Koria, Veliko Tarnovo, 5047, Bulgaria

Location

Vanda Investigational Site

Kardzhali, 6600, Bulgaria

Location

Vanda Investigational Site

Lovech, 5500, Bulgaria

Location

Vanda Investigational Site

Veliko Tarnovo, 5000, Bulgaria

Location

Vanda Investigational Site

Vratsa, 3001, Bulgaria

Location

Vanda Investigational Site

Tuszyn, 95-080, Poland

Location

Related Publications (1)

  • Torres R, Czeisler EL, Chadwick SR, Stahl SM, Smieszek SP, Xiao C, Polymeropoulos CM, Birznieks G, Polymeropoulos MH. Efficacy and Safety of Iloperidone in Bipolar Mania: A Double-Blind, Placebo-Controlled Study. J Clin Psychiatry. 2024 Jan 15;85(1):23m14966. doi: 10.4088/JCP.23m14966.

    PMID: 38236020DERIVED

MeSH Terms

Interventions

iloperidone

Results Point of Contact

Title
Vanda Pharmaceuticals
Organization
Vanda Pharmaceuticals
clinicaltrials@vandapharma.com
202-734-3400

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 29, 2021

Study Start

March 22, 2021

Primary Completion

September 7, 2022

Study Completion

August 16, 2023

Last Updated

April 18, 2024

Results First Posted

April 16, 2024

Record last verified: 2024-04

Locations

BU(6)PL(1)US(20)