Schizophrenia Clinical Trial
Official title:
A Randomised, Double-blind, Parallel-group, Active-controlled, Flexible Dose Study Exploring the Efficacy and Safety of 12 Weeks Treatment With Lu 31-130 in Patients With Schizophrenia
The main purpose with the study is to explore the efficacy and safety of Lu 31-130 in patients suffering from schizophrenia compared to a standard antipsychotic drug.
Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of
the world's population. Antipsychotic drugs remain the cornerstone in the pharmacotherapy of
schizophrenia. However, none of the available drugs is ideal, in particular because of their
complex safety profile and the limited effectiveness against certain symptom domains.
Whereas positive symptoms respond to treatment the effects on negative symptoms and
cognitive impairment are only very modest.
Thus present treatment options leave room for improvement and call for new, more effective
pharmacotherapies for the treatment of schizophrenia. In the current study, patients
suffering from schizophrenia and experiencing clinically significant symptoms of the disease
will be included. Eligible patients will be randomised to blinded treatment with either
flexible doses of Lu 31-130 or flexible doses of a standard antipsychotic treatment
(olanzapine) for 12 weeks. The efficacy (including potential effects on cognitive symptoms)
and the safety of Lu 31-130 will be explored in comparison to olanzapine.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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