Efficacy Study Exploring the Effect of Lu AE58054 as Augmentation Therapy in Patients With Schizophrenia

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to explore the efficacy, safety and cognitive properties of Lu AE58054 as augmentation therapy to risperidone in patients with schizophrenia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• Primary diagnosis of schizophrenia

• Man or woman, aged between 18-65

• Patient is on an optimised dose of risperidone (within 4-8 mg/day) for the treatment of schizophrenia for a minimum of 4 weeks prior to screening

• The patient has a PANSS total score between 70 and 100 (extremes included) at screening

Exclusion Criteria:

• Primary psychiatric diagnosis other than 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

• Significant ECG abnormalities

• In concurrent treatment with drugs inhibiting the P450 enzymes system CYP2D6 and other CYP Isozymes

• Failed to respond to adequate courses of treatment with risperidone

• Treated with an antipsychotic other than risperidone within 4 weeks prior to screening