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Add-on clinical effects of selective antagonist of 5HT6 receptors AVN-211 (CD-008-0173) in patients with schizophrenia stabilized on antipsychotic treatment: pilot study

Published online by Cambridge University Press:  17 June 2013

Margarita A. Morozova ,
Taisiya A. Lepilkina ,
Georgy E. Rupchev ,
Allan G. Beniashvily ,
Denis S. Burminskiy ,
Sergey S. Potanin ,
Evgeny V. Bondarenko ,
Vasily I. Kazey ,
Yan Lavrovsky  and
Alexandre V. Ivachtchenko
Margarita A. Morozova*
Affiliation:
Laboratory of Psychopharmacology, National Center of Mental Health, Russian Academy of Medical Science, Moscow, Russia
Taisiya A. Lepilkina
Affiliation:
Laboratory of Psychopharmacology, National Center of Mental Health, Russian Academy of Medical Science, Moscow, Russia
Georgy E. Rupchev
Affiliation:
Laboratory of Psychopharmacology, National Center of Mental Health, Russian Academy of Medical Science, Moscow, Russia
Allan G. Beniashvily
Affiliation:
Laboratory of Psychopharmacology, National Center of Mental Health, Russian Academy of Medical Science, Moscow, Russia
Denis S. Burminskiy
Affiliation:
Laboratory of Psychopharmacology, National Center of Mental Health, Russian Academy of Medical Science, Moscow, Russia
Sergey S. Potanin
Affiliation:
Laboratory of Psychopharmacology, National Center of Mental Health, Russian Academy of Medical Science, Moscow, Russia
Evgeny V. Bondarenko
Affiliation:
Avineuro LLC, Moscow, Russia
Vasily I. Kazey
Affiliation:
Avineuro LLC, Moscow, Russia
Yan Lavrovsky
Affiliation:
Avineuro Pharmaceuticals Inc., San Diego, California, USA
Alexandre V. Ivachtchenko
Affiliation:
Avineuro Pharmaceuticals Inc., San Diego, California, USA Chemical Diversity Research Institute, Khimki, Moscov Region, Russia
*
Address for correspondence: Margarita Morozova, National Center of Mental Health, Russian Academy of Medical Science, Kashirskoye shosse, 34, Moscow 115522, Russia. Email margmorozova@gmail.com
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Abstract

The serotoninergic system as a target for add-on treatment seems to be a promising approach in patients with schizophrenia.

Objective

To clarify if selective 5HT-6 antagonist AVN-211 (CD-008-0173) adds clinical and cognitive effects to stable antipsychotic treatment.

Methods

A randomized, double-blind, placebo-controlled, add-on, 4r-week trial in 47 schizophrenia patients (21 patients receiving study drug and 26 receiving placebo) who were stabilized on antipsychotic medication was performed. Seventeen patients from the study drug group and 25 patients from the placebo group completed the trial. Treatment effects were measured using clinical rating scales and attention tests.

Results

With no differences at baseline, there was a significant difference between the groups in Positive and Negative Syndrome Scale (PANSS) positive subscale score (p = 0.058) in favor of patients in the treatment group at the endpoint. The PANSS positive subscore (p = 0.0068) and Clinical Global Impression–Severity (CGI-S) (p = 0.048) score significantly changed only in the treatment group. Only in the placebo group were significant changes in Calgary Depression Rating Scale (CDRS) total score registered. The indices of attention tests at endpoint did not show differences between the groups, with the exception of the scope of change in the results of the subtest VIII of the Wechsler Adult Intelligence Scale (WAIS), which showed difference between the groups (p = 0.02) and was significantly larger in the treatment group. Only inside the study drug group, significant changes in selectivity and continuous attention were observed regarding total correct responses (p = 0.0038) and reaction time (p = 0.058) in the Continuous Attention Task (CAT) test.

Conclusion

Selective 5HT6 antagonist AVN-211 (CD-008-0173) added antipsychotic and some procognitive (attention) effects to antipsychotic medication.

Keywords

5HT6 receptor antagonistadd-onclinical effectsschizophrenia
Type
Original Research
Information
CNS Spectrums , Volume 19 , Issue 4 , August 2014 , pp. 316 - 323
Copyright
Copyright © Cambridge University Press 2013 

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