Efficacy and safety of fezolamine in depressed patients.
Forty-two outpatients with major depressive disorder were treated with oral fezolamine in a 6-week, three-center open-label study. Therapy was initiated at 100 mg/day; thereafter dosage was increased based on the response of the patient. Maintenance dosage usually ranged between 100 and 450 mg/day. Clinically significant improvement relative to the patient's prestudy state was observed after 2 weeks in both patient and physician-rating scales. Fifty-five percent of patients improved their Hamilton Psychiatric Rating Scale for Depression (HAM-D) scores by more than 50%. The median dose associated with a clinically significant response was 245 mg/day. Five of the 6 patients who dropped out did so because of gastrointestinal adverse effects. The most common adverse effects were nausea (36%), headache (29%), constipation (26%), and dry mouth (24%).
Zisook
S
S
UCSD Department of Psychiatry.
Mendels
J
J
Janowsky
D
D
Feighner
J
J
Lee
J C
JC
Fritz
A
A
D000328:Adult; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D011720:Pyrazoles / Q000009:adverse effects / Q000627:therapeutic use*
D000928:Antidepressive Agents; D011720:Pyrazoles; C047153:fezolamine