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

Phase 3CompletedNCT04819776

Vanda Pharmaceuticals417 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

417

Conditions

Bipolar I Disorder

Interventions

IloperidoneDRUG

Oral iloperidone

Iloperidone PlaceboDRUG

Oral placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (27)

Vanda Investigational Site

Outcomes

Primary Outcomes

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

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).

Time frame: Week 4

Data from ClinicalTrials.gov

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