title: An open label trial of C-1073 (mifepristone) for psychotic major depression.
abstract: BACKGROUND
  The rationale for treating patients with psychotic major depression (PMD) with glucocorticosteroid receptor (GR) antagonists is explained.
  
  
  METHODS
  Thirty patients with PMD, with Hamilton Rating Scale for Depression (HAMD-21) scores of 18 or greater, were assigned in an open label trial to receive 50 mg, 600 mg, or 1200 mg of mifepristone for 7 days.
  
  
  RESULTS
  All the subjects completed the protocol; there were no dropouts. Side effects were mild and sporadic. Of 19 subjects in the combined 600- and 1200-mg group, 13 had a 30% or greater decline in their Brief Psychiatric Rating Scale (BPRS) scores, compared with 4 of 11 in the 50-mg group. In the 600- and 1200-mg group, 12 of 19 subjects showed a 50% decline in the BPRS positive symptom subscale, a more sensitive index for the symptoms seen in PMD, compared with 3 of 11 in the 50-mg group; 8 of 19 subjects in the 600- and 1200-mg group had a 50% decline in the HAMD-21, compared with 2 of 11 in the 50-mg group.
  
  
  CONCLUSIONS
  These results suggest that short term use of GR antagonists may be effective in the treatment of psychotic major depression and that further blinded studies are warranted.
authors.affiliation: Corcept Therapeutics Inc., Menlo Park, California 94025, USA.
authors.forename: Joseph K
authors.initials: JK
authors.lastname: Belanoff
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Rothschild
authors.forename: Frederick
authors.initials: F
authors.lastname: Cassidy
authors.forename: Charles
authors.initials: C
authors.lastname: DeBattista
authors.forename: Etienne-Emile
authors.initials: EE
authors.lastname: Baulieu
authors.forename: Clifford
authors.initials: C
authors.lastname: Schold
authors.forename: Alan F
authors.initials: AF
authors.lastname: Schatzberg
mesh_terms: D000328:Adult; D000368:Aged; D003865:Major Depressive Disorder / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006727:Hormone Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D015735:Mifepristone / Q000008:administration & dosage* / Q000627:therapeutic use; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
chemical_list: D006727:Hormone Antagonists; D015735:Mifepristone