An open label trial of C-1073 (mifepristone) for psychotic major depression.
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.
Belanoff
Joseph K
JK
Corcept Therapeutics Inc., Menlo Park, California 94025, USA.
Rothschild
Anthony J
AJ
Cassidy
Frederick
F
DeBattista
Charles
C
Baulieu
Etienne-Emile
EE
Schold
Clifford
C
Schatzberg
Alan F
AF
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
D006727:Hormone Antagonists; D015735:Mifepristone