Sertindole in Asian Patients With Schizophrenia

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of sertindole in patients with schizophrenia in Asia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Olanzapine; Sertindole

Criteria

Inclusion Criteria:

• Male and female patients, aged 18-65 years (extremes included), suffering from schizophrenia

• Positive and Negative Syndrome Scales (PANSS) total score between 60 and 120 (extremes included) at screening and baseline

• Based on the patient's clinical status, an antipsychotic treatment is indicated

• Otherwise healthy

• Female patients of non-childbearing potential, or non-pregnant, not breast-feeding women of childbearing potential, using adequate birth control methods

Exclusion Criteria:

• Current Axis I primary psychiatric diagnosis other than schizophrenia

• Has never before received antipsychotic drugs

• Has received a depot antipsychotic medication within less than one dose interval prior to Screening

• History of clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia (<50 beats per minute)

• Congenital long QT syndrome or a family history of this disease, or in patients with known acquired QT interval prolongation (QTc above 450 msec in males and 470 msec in females at Screening)

• Significant risk of suicide and/or violent behaviour

• Known history of narrow angle glaucoma

• Substance or alcohol abuse, current alcohol dependence

• Use of disallowed concomitant medication

Other protocol-defined inclusion and exclusion criteria may apply.