Status:
COMPLETED
Evaluation of Efficacy and Safety of Iloperidone in the Acute Treatment of Manic or Mixed Episodes Associated With Bipolar I Disorder
Lead Sponsor:
Vanda Pharmaceuticals
Conditions:
Bipolar I Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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
- 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
- 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
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 16 2023
Estimated Enrollment :
417 Patients enrolled
Trial Details
Trial ID
NCT04819776
Start Date
March 22 2021
End Date
August 16 2023
Last Update
April 18 2024
Active Locations (27)
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1
Vanda Investigational Site
Little Rock, Arkansas, United States, 72211
2
Vanda Investigational Site
Rogers, Arkansas, United States, 72758
3
Vanda Investigational Site
Cerritos, California, United States, 90703
4
Vanda Investigational Site
Culver City, California, United States, 90230