title: A double-blind, placebo controlled, randomized trial of riluzole as an adjunct to risperidone for treatment of negative symptoms in patients with chronic schizophrenia.
abstract: BACKGROUND
  Several recent studies have focused on glutamate modulating agents for symptoms relief in schizophrenia, especially negative symptoms which are resistant to conventional therapies.
  
  
  OBJECTIVE
  We aimed to assess the efficacy and tolerability of riluzole, an anti-glutamate agent with neuroprotective properties, as an adjunct to risperidone in improving negative symptoms of schizophrenia.
  
  
  METHODS
  In this randomized double-blind placebo-controlled parallel-group study, 50 patients with chronic schizophrenia and a score of ≥20 on the negative subscale of positive and negative syndrome scale (PANSS) were enrolled in the active phase of their illness. Participants were equally randomized to receive riluzole (100 mg/day) or placebo in addition to risperidone (up to 6 mg/day) for 8 weeks. Participants were rated by PANSS every 2 weeks. The primary outcome of this study was the difference in the decrease of PANSS negative subscale score from baseline to the study endpoint between the two groups.
  
  
  RESULTS
  By the study endpoint, riluzole-treated patients showed significantly greater improvement in the negative symptoms (P < 0.001) as well as the PANSS total and general psychopathology subscale scores (P = 0.001 and P < 0.001; respectively) compared to the placebo group. Treatment group was the only significant predictor of changes in negative symptom in this trial (β = -0.56, P < 0.001). No significant difference was observed between two groups in the frequency of side effects.
  
  
  CONCLUSIONS
  These preliminary findings suggest that riluzole may be a safe and effective medication for the treatment of negative symptoms in patients with chronic schizophrenia. Further research and replication of study findings is warranted. Clinical trial registry name and registration number: Iranian registry of clinical trials www.irct.ir , IRCT201107281556N26
authors.affiliation: Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran, 13337, Iran.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Farokhnia
authors.forename: Maryam
authors.initials: M
authors.lastname: Sabzabadi
authors.forename: Hossein
authors.initials: H
authors.lastname: Pourmahmoud
authors.forename: Mohammad-Reza
authors.initials: MR
authors.lastname: Khodaie-Ardakani
authors.forename: Seyed-Mohammad-Reza
authors.initials: SM
authors.lastname: Hosseini
authors.forename: Habibeh
authors.initials: H
authors.lastname: Yekehtaz
authors.forename: Mina
authors.initials: M
authors.lastname: Tabrizi
authors.forename: Farzin
authors.initials: F
authors.lastname: Rezaei
authors.forename: Bahman
authors.initials: B
authors.lastname: Salehi
authors.forename: Shahin
authors.initials: S
authors.lastname: Akhondzadeh
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002908:Chronic Disease; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000009:adverse effects; D018691:Excitatory Amino Acid Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D018696:Neuroprotective Agents / Q000009:adverse effects / Q000627:therapeutic use; D011569:Psychiatric Status Rating Scales; D019782:Riluzole / Q000009:adverse effects / Q000627:therapeutic use*; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy*; D012565:Schizophrenic Psychology; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents; D018691:Excitatory Amino Acid Antagonists; D018696:Neuroprotective Agents; D019782:Riluzole; D018967:Risperidone