Overview
Evaluation of Efficacy and Safety of Iloperidone in the Treatment of Bipolar I Disorder
Status:
Recruiting
Recruiting
Trial end date:
2023-05-01
2023-05-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Vanda PharmaceuticalsTreatments:
Iloperidone
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