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

Phase 3

Completed

• Conditions: Bipolar I Disorder
• Interventions: Drug: Iloperidone Placebo; Drug: Iloperidone

• Registration Number: NCT04819776
• Lead Sponsor: Vanda Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-22
• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-29
• Primary Completion: 2022-09-07
• Study Completion: 2023-08-16
• Results First Submitted: 2024-03-19
• Results First Submitted QC: 2024-03-19
• Status Verified: 2024-04
• Results First Posted: 2024-04-16
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 417

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Iloperidone Placebo	-
Iloperidone	Iloperidone	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 4 in Young Mania Rating Scale (YMRS) Total Score	Week 4	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).

Trial Locations

Locations (1)

Vanda Investigational Site; 🇵🇱 Tuszyn, Poland