Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to explore the neurocognitive efficacy of Sertindole versus comparator in patients with schizophrenia using the MCCB.

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

Details

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

Criteria

Inclusion Criteria:

• Primary diagnosis of schizophrenia

• Man or woman, aged between 18 and 55 years

Exclusion Criteria:

• Current Axis I primary psychiatric diagnosis other than schizophrenia

• Not previously received antipsychotic drugs for schizophrenia

• Acute exacerbation requiring hospitalisation within the last 3 months

• Clinically significant extrapyramidal symptoms

• Clinically significant cardiovascular disease, congestive heart failure, cardiac hypertrophy, arrhythmia or bradycardia

• Congenital long QT syndrome or a family history of this disease, or known acquired QT interval prolongation

• Significant ECG abnormalities

• Hypokalaemia or hypomagnesaemia

• In concurrent treatment with drugs inhibiting the P450 enzymes system CYP3A