title: A placebo-controlled study of the modafinil added to risperidone in chronic schizophrenia.
abstract: BACKGROUND
  In recent years, evidence suggests that modafinil may be useful for certain symptom domains of schizophrenia, especially for the negative and cognitive symptoms. However, the results are not consistent.
  
  
  OBJECTIVE
  This study was designed to investigate the effect of modafinil added to risperidone in patients with chronic schizophrenia in a double blind and randomized clinical trial.
  
  
  METHODS
  Participants were inpatients males (35) and females (11), ages 20-49 years at two teaching psychiatric hospital in Iran. All patients were in the active phase of the illness and met DSM-IV-TR criteria for schizophrenia. Patients were allocated in a random fashion 23 patients to risperidone 6 mg/day plus modafinil 200 mg/day and 23 patients to risperidone 6 mg/day plus placebo. The principal measure of outcome was the positive and negative syndrome scale (PANSS). Patients were assessed by a psychiatrist at baseline and after 2, 4, 6 and 8 weeks after the start of medication.
  
  
  RESULTS
  The modafinil group had significantly greater improvement in the negative symptoms as well as PANSS total scores over the 8-week trial. Therapy with 200 mg/day of modafinil was well tolerated and no clinically important side effects were observed.
  
  
  CONCLUSIONS
  The present study indicates modafinil as a potential adjunctive treatment strategy for treatment of schizophrenia particularly the negative symptoms. Nevertheless, results of larger-controlled trials are needed before recommendation for broad clinical application can be made.
authors.affiliation: Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, South Kargar Street, Tehran, 13337, Iran.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Arbabi
authors.forename: Mohaddeseh
authors.initials: M
authors.lastname: Bagheri
authors.forename: Farzin
authors.initials: F
authors.lastname: Rezaei
authors.forename: Seyyed-Ali
authors.initials: SA
authors.lastname: Ahmadi-Abhari
authors.forename: Mina
authors.initials: M
authors.lastname: Tabrizi
authors.forename: Farahnaz
authors.initials: F
authors.lastname: Khalighi-Sigaroudi
authors.forename: Shahin
authors.initials: S
authors.lastname: Akhondzadeh
mesh_terms: D000328:Adult; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001559:Benzhydryl Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002908:Chronic Disease; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006778:Hospitals, Psychiatric; D006784:Hospitals, Teaching; D006801:Humans; D007492:Iran; D008297:Male; D008875:Middle Aged; D000077408:Modafinil; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000008:administration & dosage / Q000627:therapeutic use*; D012559:Schizophrenia / Q000188:drug therapy* / Q000503:physiopathology; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D018967:Risperidone; D000077408:Modafinil