Clinical trial NCT04819776: Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Iloperidone for 4 Weeks in the Treatment of Patients With Acute Manic Episodes Associated With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar I Disorder
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-03-29
Enrollment: 417
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Vanda Investigational Site
state: Arkansas
city: Rogers
country: United States
facility: Vanda Investigational Site
state: Arkansas
city: Cerritos
country: United States
facility: Vanda Investigational Site
state: California
city: Culver City
country: United States
facility: Vanda Investigational Site
state: California
city: Long Beach
country: United States
facility: Vanda Investigational Site
state: California
city: Orange
country: United States
facility: Vanda Investigational Site
state: California
city: Torrance
country: United States
facility: Vanda Investigational Site
state: California
city: Miami Lakes
country: United States
facility: Vanda Investigational Site
state: Florida
city: Oakland Park
country: United States
facility: Vanda Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Vanda Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Vanda Investigational Site
state: Georgia
city: Gaithersburg
country: United States
facility: Vanda Investigational Site
state: Maryland
city: Flowood
country: United States
facility: Vanda Investigational Site
state: Mississippi
city: Las Vegas
country: United States
facility: Vanda Investigational Site
state: Nevada
city: Marlton
country: United States
facility: Vanda Investigational Site
state: New Jersey
city: Dayton
country: United States
facility: Vanda Investigational Site
state: Ohio
city: North Canton
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Austin
country: United States
facility: Vanda Investigational Site
state: Texas
city: DeSoto
country: United States
facility: Vanda Investigational Site
state: Texas
city: Richardson
country: United States
facility: Vanda Investigational Site
state: Texas
city: Novi Iskar
country: Bulgaria
facility: Vanda Investigational Site
state: Sofia City
city: Tserova Koria
country: Bulgaria
facility: Vanda Investigational Site
state: Veliko Tarnovo
city: Kardzhali
country: Bulgaria
facility: Vanda Investigational Site
city: Lovech
country: Bulgaria
facility: Vanda Investigational Site
city: Veliko Tarnovo
country: Bulgaria
facility: Vanda Investigational Site
city: Vratsa
country: Bulgaria
facility: Vanda Investigational Site
city: Tuszyn
country: Poland
facility: Vanda Investigational Site
Study officials:
References: