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

Vanda Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Bipolar I Disorder

Treatments: Drug: Iloperidone; Drug: Iloperidone Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04819776

VP-VYV-683-3201

Details and patient eligibility

About

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.

Enrollment: 417 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

417 participants in 2 patient groups, including a placebo group

Iloperidone

Experimental group

Treatment:

Drug: Iloperidone

Placebo

Placebo Comparator group

Treatment:

Drug: Iloperidone Placebo