Schizophrenia Clinical Trial
Official title:
A 6-month, Randomised, Double-blind, Parallel-group, Risperidone-controlled, Fixed-dose Study Evaluating the Safety and Efficacy of Zicronapine in Patients With Schizophrenia
To assess the effect of zicronapine versus risperidone on metabolic parameters comprising body weight, body mass index (BMI), waist circumference, levels of fasting blood lipids and glucose during 6 months of treatment.
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. There are a number of antipsychotic drugs in use but none is ideal, in
particular because their safety profile is complex and their effectiveness is limited.
Thus, present treatment options leave room for improvement and call for new, more effective
pharmacotherapies for the treatment of schizophrenia. In the current study, non-acute
patients with schizophrenia will be randomised to blinded treatment with either zicronapine
or a standard antipsychotic treatment for 24 weeks. The safety (with focus on metabolic
parameters) and efficacy of zicronapine will be evaluated in comparison to risperidone.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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