Efficacy and Safety of Iloperidone Compared With Placebo and Active Control in Subjects With Acute Schizophrenia

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Iloperidone; Drug: Placebo; Drug: Ziprasidone

• Registration Number: NCT00254202
• Lead Sponsor: Vanda Pharmaceuticals

Brief Summary

The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.

Detailed Description

Schizophrenia is a severe mental illness affecting an estimated 1% of the world's population. Patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or emotions). Other symptoms include a reduced ability to recall and learn new information.

Iloperidone is being development as a treatment for symptoms of schizophrenia. This trial will test the safety and efficacy of iloperidone in patients with an acute exacerbation of the disease.

Study Timeline

• Study First Submitted: 2005-11-10
• Study First Submitted QC: 2005-11-10
• Study First Posted: 2005-11-15
• Study Start: 2005-11-18
• Primary Completion: 2006-09-26
• Study Completion: 2007-03-21
• Results First Submitted: 2024-04-01
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-11
• Last Update Submitted: 2024-12-11
• Results First Posted: 2024-12-13
• Last Update Posted: 2024-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 593

Inclusion Criteria

• DSM-IV diagnosis of schizophrenia
• PANSS-T of at least 70 at screening and baseline

Exclusion Criteria

• Clinically significant disease of the heart, kidneys, liver or gastrointestinal system
• DSM-IV diagnosis of psychiatric disorder other than schizophrenia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iloperidone	Iloperidone	Oral iloperidone
Placebo	Placebo	Oral placebo
Ziprasidone	Ziprasidone	Oral ziprasidone

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Positive and Negative Symptom Scale Total (PANSS-T) Score	4 weeks	The PANSS is a 30-item scale developed to assess the severity of symptoms of schizophrenia. The PANSS items are divided into positive, negative, and general psychopathology factors. Items are rated on a scale of 1 (absent) to 7 (extremely severe). The PANSS-T score is the sum of scores for all 30 PANSS items (i.e., the sum of the three subscales), with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms. A negative change from baseline indicates improvement.

Trial Locations

Locations (2)

Vanda Investigational Site; 🇮🇳 Chinawaltair, Visakha Patnam, India

Vanda Investgational Site; 🇮🇳 Chennai, Tamilnadu, India