title: 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.
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.
  
  
  CONCLUSIONS
  Selective 5HT6 antagonist AVN-211 (CD-008-0173) added antipsychotic and some procognitive (attention) effects to antipsychotic medication.
authors.affiliation: 1Laboratory of Psychopharmacology,National Center of Mental Health,Russian Academy of Medical Science,Moscow,Russia.
authors.forename: Margarita A
authors.initials: MA
authors.lastname: Morozova
authors.affiliation: 1Laboratory of Psychopharmacology,National Center of Mental Health,Russian Academy of Medical Science,Moscow,Russia.
authors.forename: Taisiya A
authors.initials: TA
authors.lastname: Lepilkina
authors.affiliation: 1Laboratory of Psychopharmacology,National Center of Mental Health,Russian Academy of Medical Science,Moscow,Russia.
authors.forename: Georgy E
authors.initials: GE
authors.lastname: Rupchev
authors.affiliation: 1Laboratory of Psychopharmacology,National Center of Mental Health,Russian Academy of Medical Science,Moscow,Russia.
authors.forename: Allan G
authors.initials: AG
authors.lastname: Beniashvily
authors.affiliation: 1Laboratory of Psychopharmacology,National Center of Mental Health,Russian Academy of Medical Science,Moscow,Russia.
authors.forename: Denis S
authors.initials: DS
authors.lastname: Burminskiy
authors.affiliation: 1Laboratory of Psychopharmacology,National Center of Mental Health,Russian Academy of Medical Science,Moscow,Russia.
authors.forename: Sergey S
authors.initials: SS
authors.lastname: Potanin
authors.affiliation: 2Avineuro LLC,Moscow,Russia.
authors.forename: Evgeny V
authors.initials: EV
authors.lastname: Bondarenko
authors.affiliation: 2Avineuro LLC,Moscow,Russia.
authors.forename: Vasily I
authors.initials: VI
authors.lastname: Kazey
authors.affiliation: 3Avineuro Pharmaceuticals Inc.,San Diego,California,USA.
authors.forename: Yan
authors.initials: Y
authors.lastname: Lavrovsky
authors.affiliation: 3Avineuro Pharmaceuticals Inc.,San Diego,California,USA.
authors.forename: Alexandre V
authors.initials: AV
authors.lastname: Ivachtchenko
mesh_terms: D000328:Adult; D000818:Animals; D014150:Antipsychotic Agents / Q000627:therapeutic use*; D001288:Attention; D001522:Behavior, Animal / Q000187:drug effects; D018680:Cholinergic Antagonists / Q000494:pharmacology; D002800:Cholinesterase Inhibitors / Q000494:pharmacology; D003071:Cognition; D000077265:Donepezil; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007189:Indans / Q000494:pharmacology; D008297:Male; D018782:Maze Learning / Q000187:drug effects; D051379:Mice; D008807:Mice, Inbred BALB C; D008875:Middle Aged; D010865:Pilot Projects; D010880:Piperidines / Q000494:pharmacology; D065808:Prepulse Inhibition / Q000187:drug effects; D011720:Pyrazoles / Q000494:pharmacology / Q000627:therapeutic use*; D011743:Pyrimidines / Q000494:pharmacology / Q000627:therapeutic use*; D011930:Reaction Time; D011985:Receptors, Serotonin; D013216:Reflex, Startle / Q000187:drug effects; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D012601:Scopolamine / Q000494:pharmacology; D012702:Serotonin Antagonists / Q000494:pharmacology / Q000627:therapeutic use*; D013619:Tacrine / Q000494:pharmacology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C000609554:3-sulfonyl-pyrazolo(1,5-a)pyrimidine; D014150:Antipsychotic Agents; D018680:Cholinergic Antagonists; D002800:Cholinesterase Inhibitors; D007189:Indans; D010880:Piperidines; D011720:Pyrazoles; D011743:Pyrimidines; D011985:Receptors, Serotonin; D012702:Serotonin Antagonists; C097216:serotonin 6 receptor; D013619:Tacrine; D000077265:Donepezil; D012601:Scopolamine