Status:
COMPLETED
Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Schizophrenia
Cognition
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
The objective of this study is to explore the neurocognitive efficacy of Sertindole versus comparator in patients with schizophrenia using the MCCB.
Detailed Description
Sertindole is an atypical antipsychotic approved in the European Union (EU) for use in patients with schizophrenia who are intolerant to at least one other antipsychotic agent. During clinical develop...
Eligibility Criteria
Inclusion
- Primary diagnosis of schizophrenia
- Man or woman, aged between 18 and 55 years
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT00654706
Start Date
March 1 2008
End Date
March 1 2010
Last Update
May 28 2014
Active Locations (26)
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1
US017
Garden Grove, California, United States, 92845
2
US008
National City, California, United States, 91950
3
US001
Pasadena, California, United States, 91107
4
US006
Pico Rivera, California, United States, 90660