An open label trial of C-1073 (mifepristone) for psychotic major depression
Department of Psychiatry
Adult; Aged; Depressive Disorder, Major; Dose-Response Relationship, Drug; Female; Hormone Antagonists; Humans; Male; Middle Aged; Mifepristone; Psychiatric Status Rating Scales; Treatment Outcome
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.
Biol Psychiatry. 2002 Sep 1;52(5):386-92.
Belanoff, Joseph K.; Rothschild, Anthony J.; Cassidy, Frederick; DeBattista, Charles; Emile Baulieu, Etienne; Schold, Clifford; and Schatzberg, Alan F., "An open label trial of C-1073 (mifepristone) for psychotic major depression" (2002). Psychiatry Publications and Presentations. 56.