title: A placebo-controlled study of tropisetron added to risperidone for the treatment of negative symptoms in chronic and stable schizophrenia.
abstract: BACKGROUND
  A growing body of evidence illustrates that 5-HT3 receptor antagonist drugs may be of benefit in the treatment of negative symptoms in schizophrenia.
  
  
  OBJECTIVE
  The objective of this study was to assess the efficacy and tolerability of tropisetron add-on to risperidone on negative symptoms in patients with chronic stable schizophrenia.
  
  
  METHODS
  In a double-blind, placebo-controlled 8-week trial, 40 patients with chronic schizophrenia who were stabilized on risperidone were randomized into tropisetron or placebo add-on groups. Psychotic symptoms were measured using the Positive and Negative Syndrome Scale (PANSS) every 2 weeks. Furthermore, extrapyramidal and depressive symptoms as well as side effects were assessed. The primary outcome measure was the difference in change from baseline of negative subscale scores between the two groups at week 8.
  
  
  RESULTS
  Tropisetron resulted in greater improvement of the total PANSS scores [F(1.860,70.699) = 37.366, p < 0.001] as well as negative scores [F(2.439,92.675) = 16.623, p < 0.001] and general psychopathology [F(1.767,67.158) = 4.602, p = 0.017], but not positive subscale scores [F(1.348, 51.218) = 0.048, p = 0.893] compared to placebo. In a multiple regression analysis controlling for positive, extrapyramidal, and depressive symptoms, treatment group (standardized β = -0.640) significantly predicted changes in primary negative symptoms. The side effect profile did not differ significantly between the two groups.
  
  
  CONCLUSIONS
  Tropisetron add-on to risperidone improves the primary negative symptoms of patients with chronic stable schizophrenia.
authors.affiliation: Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran, 13337, Iran.
authors.forename: Maryam
authors.initials: M
authors.lastname: Noroozian
authors.forename: Sina
authors.initials: S
authors.lastname: Ghasemi
authors.forename: Seyed-Mohammad-Reza
authors.initials: SM
authors.lastname: Hosseini
authors.forename: Amirhossein
authors.initials: A
authors.lastname: Modabbernia
authors.forename: Mohammad-Reza
authors.initials: MR
authors.lastname: Khodaie-Ardakani
authors.forename: Omid
authors.initials: O
authors.lastname: Mirshafiee
authors.forename: Mehdi
authors.initials: M
authors.lastname: Farokhnia
authors.forename: Masih
authors.initials: M
authors.lastname: Tajdini
authors.forename: Farzin
authors.initials: F
authors.lastname: Rezaei
authors.forename: Bahman
authors.initials: B
authors.lastname: Salehi
authors.forename: Mandana
authors.initials: M
authors.lastname: Ashrafi
authors.forename: Habibeh
authors.initials: H
authors.lastname: Yekehtaz
authors.forename: Mina
authors.initials: M
authors.lastname: Tabrizi
authors.forename: Shahin
authors.initials: S
authors.lastname: Akhondzadeh
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D012044:Regression Analysis; D018967:Risperidone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy* / Q000503:physiopathology; D012565:Schizophrenic Psychology; D012702:Serotonin Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D012720:Severity of Illness Index; D016896:Treatment Outcome; D000077526:Tropisetron
chemical_list: D014150:Antipsychotic Agents; D007211:Indoles; D012702:Serotonin Antagonists; D000077526:Tropisetron; D018967:Risperidone