title: A preliminary open-label study of zonisamide treatment for bipolar depression in 10 patients.
abstract: OBJECTIVE
  The purpose of this study was to investigate the effectiveness of zonisamide in the treatment of bipolar depression.
  
  
  METHODS
  Ten patients with DSM-IV bipolar disorder, depressed phase, who had either not tolerated or not responded to previous treatments were given zonisamide in this add-on open-label study. Zonisamide treatment was started at 100 mg/day and increased by 100 mg every 2 weeks to a maximum of 300 mg/day in divided doses (b.i.d. or t.i.d.). Subjects underwent weekly visits at which they were administered the 17-item Hamilton Rating Scale for Depression (HAM-D), Young Mania Rating Scale (YMRS), and Clinical Global Impressions scale (CGI). Every 2 weeks, subjects also underwent laboratory tests, a urine examination, and a verbal memory test. Outcome measures were analyzed with repeated-measures analysis of variance.
  
  
  RESULTS
  Eight subjects completed all 8 weeks of the study. Two subjects completed more than 4 weeks of the study, and their data were analyzed using the last observation carried forward. Bipolar depression subjects had a significant reduction in HAM-D scores (p < .001) and in CGI-Improvement (CGI-I) scores (p < .001). Five of 8 subjects who completed all 8 weeks of the study had more than a 50% decrease in HAM-D scores and were rated much improved on the CGI-I at the end of 8 weeks of treatment. There was no significant drug effect on YMRS scores, weight, or verbal memory.
  
  
  CONCLUSIONS
  Zonisamide may be a useful drug in the treatment of bipolar depression. Further controlled clinical trials are needed.
authors.affiliation: Department of Psychiatry, Indiana University School of Medicine, IN 46202, USA. aanand@iupui.edu
authors.forename: Amit
authors.initials: A
authors.lastname: Anand
authors.forename: Lubna
authors.initials: L
authors.lastname: Bukhari
authors.forename: Shirley A
authors.initials: SA
authors.lastname: Jennings
authors.forename: Cynthia
authors.initials: C
authors.lastname: Lee
authors.forename: Mamata
authors.initials: M
authors.lastname: Kamat
authors.forename: Anantha
authors.initials: A
authors.lastname: Shekhar
authors.forename: John I
authors.initials: JI
authors.lastname: Nurnberger
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Lightfoot
mesh_terms: D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007555:Isoxazoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D011619:Psychotropic Drugs / Q000627:therapeutic use; D016896:Treatment Outcome; D000078305:Zonisamide
chemical_list: D000927:Anticonvulsants; D007555:Isoxazoles; D011619:Psychotropic Drugs; D000078305:Zonisamide