Original scientific paper

DOUBLE-BLIND PLACEBO-CONTROLLED RANDOMIZED EFFICACY AND SAFETY TRIAL OF ADD-ON TREATMENT OF DIMEBON PLUS RISPERIDONE IN SCHIZOPHRENIC PATIENTS DURING TRANSITION FROM ACUTE PSYCHOTIC EPISODE TO REMISSION

Margarita A. Morozova orcid.org/0000-0002-7847-2716 ; Laboratory of psychopharmacology, Mental Health Research Center of Russian Academy of Medical Sciences, Moscow, Russia
Allan G. Beniashvili ; Laboratory of psychopharmacology, Mental Health Research Center of Russian Academy of Medical Sciences, Moscow, Russia
Taisiya A. Lepilkina ; Laboratory of psychopharmacology, Mental Health Research Center of Russian Academy of Medical Sciences, Moscow, Russia
Georgiy E. Rupchev ; Laboratory of psychopharmacology, Mental Health Research Center of Russian Academy of Medical Sciences, Moscow, Russia

Abstract

Background: There is evidence that blockade of 5-HT 6 receptors can improve cognitive dysfunction in schizophrenic patients. A
number of antagonists of 5-HT6 receptors are in development as cognitive enhancers. One of the agents with relatively strong 5-HT6
activity is dimebon. We tested the hypothesis that this 5-HT6 antagonist administered in the early stage of stabilization after an acute
episode can improve both neurocognitive and clinical symptoms in schizophrenia. A phase II study of dimebon as add-on to
risperidone therapy was conducted.
Subjects and methods: 56 male subjects with paranoid schizophrenia were included in the study. All the patients demonstrated
therapeutic response to risperidone as treatment of the acute psychotic episode. After 4 weeks of stability patients were randomized
into two groups with placebo or dimebon add-on treatment in a 1 to 1 ratio for 8 weeks. PANSS, CGI-S, CSDS and NSA-16 were
used as clinical measures of symptom severity. Different aspects of memory, psycho-motor coordination and executive functioning
were assessed with a battery of cognitive tests. Clinical and cognitive assessment was performed twice: after a patient was
randomized and 2 months later.
Results: Severity of negative symptoms (by NSA-16) were significantly lower in the dimebon group then in the placebo group
(p=0.036). Patients in the dimebon group demonstrated improvement in more cognitive dimensions than patients in the placebo
group, including working memory, attention, psycho-motor coordination and planning.
Conclusion: Dimebon as add-on therapy to antipsychotic treatment in the period of stabilization after an acute episode can
improve some aspects of clinical and cognitive status in schizophrenic patients.

Keywords

schizophrenia; cognitive dysfunction; dimebon; add-on treatment

Hrčak ID:

106218

URI

https://hrcak.srce.hr/106218

Publication date:

24.6.2012.

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