Status:
COMPLETED
Efficacy Study Exploring the Effect of Lu AE58054 as Augmentation Therapy in Patients With Schizophrenia
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Schizophrenia
Cognition
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Detailed Description
Lu AE58054 is a selective 5-HT6 antagonist that is currently being investigated for treatment of conditions of cognitive impairment associated with schizophrenia. Substantial experimental evidence sug...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00810667
Start Date
November 1 2008
End Date
February 1 2010
Last Update
November 8 2016
Active Locations (25)
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1
BE001
Liège, Belgium, 4000
2
BE005
Liège, Belgium, 4000
3
FR002
Bordeaux, France, 33076
4
FR003
Brumath, France, 67170