Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder

Completed · Phase 3 · Has a placebo group

Conditions studied: Bipolar I Disorder

In brief

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.

Key facts

Study ID

NCT04819776

Run by

Vanda Pharmaceuticals

People needed

417

Starts

2021-03-22

Expected to finish

2023-08-16

Last updated by the study team

2024-04-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Vanda Investigational Site — Little Rock, Arkansas, United States
• Vanda Investigational Site — Rogers, Arkansas, United States
• Vanda Investigational Site — Cerritos, California, United States
• Vanda Investigational Site — Culver City, California, United States
• Vanda Investigational Site — Long Beach, California, United States
• Vanda Investigational Site — Orange, California, United States
• Vanda Investigational Site — Torrance, California, United States
• Vanda Investigational Site — Miami Lakes, Florida, United States
• Vanda Investigational Site — Oakland Park, Florida, United States
• Vanda Investigational Site — Atlanta, Georgia, United States
• Vanda Investigational Site — Decatur, Georgia, United States
• Vanda Investigational Site — Gaithersburg, Maryland, United States
• Vanda Investigational Site — Flowood, Mississippi, United States
• Vanda Investigational Site — Las Vegas, Nevada, United States
• Vanda Investigational Site — Marlton, New Jersey, United States
• Vanda Investigational Site — Dayton, Ohio, United States
• Vanda Investigational Site — North Canton, Ohio, United States
• Vanda Investigational Site — Austin, Texas, United States
• Vanda Investigational Site — DeSoto, Texas, United States
• Vanda Investigational Site — Richardson, Texas, United States
• Vanda Investigational Site — Novi Iskar, Sofia-Grad, Bulgaria
• Vanda Investigational Site — Tserova Koria, Veliko Tarnovo, Bulgaria
• Vanda Investigational Site — Kardzhali, Bulgaria
• Vanda Investigational Site — Lovech, Bulgaria
• Vanda Investigational Site — Veliko Tarnovo, Bulgaria

Full record on ClinicalTrials.gov

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