A double-blind comparison of moclobemide and thioridazine versus moclobemide and placebo in the treatment of refractory, severe depression.
In a multicenter study of 78 severely depressed inpatients (44 women and 34 men; age range, 23 to 70 years), the efficacy, onset of efficacy, and tolerability of the reversible monoamine oxidase-A inhibitor moclobemide (450 mg/day) in combination with thioridazine (100 mg/day) were compared with those of moclobemide (450 mg/day) plus placebo. Patients enrolled met the DSM-III-R criteria for severe depression and had a severity score of at least 20 on the first 17 items of the Hamilton Rating Scale for Depression (HAM-D). Additionally, these patients had not responded to at least two standard antidepressants during the 2 years preceding screening and the mean duration of the current episode was 6 months. After a washout period of 3 to 5 days, patients were randomized to one of the two treatment groups, which at the outset had similar characteristics. Efficacy was assessed by the HAM-D, a depression observation rating for nurses, and a Clinical Global Impression (CGI) scale. Tolerability assessments included an overall rating, a description of adverse events, vital signs, electrocardiogram, and laboratory tests. After 4 weeks of therapy, both groups of patients showed significant improvements in HAM-D and CGI scores. The response rates (based on HAM-D > or = 50% decrease) were 74% for moclobemide/thioridazine and 77% for moclobemide/placebo, and according to CGI scores, 76 and 72% were "very much improved" or "much improved," respectively. Onset of effect was noted after 9.2 and 9.8 days, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)
Stabl
M
M
F. Hoffmann-La Roche Ltd., Basel, Switzerland.
Kasas
A
A
Blajev
B
B
Bajetta
G
G
Zöchling
R
R
Holsboer-Trachsler
E
E
Realini
R
R
Schäublin-Loidl
M
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001549:Benzamides / Q000009:adverse effects / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D004338:Drug Combinations; D004351:Drug Resistance; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D020912:Moclobemide; D011569:Psychiatric Status Rating Scales; D013881:Thioridazine / Q000009:adverse effects / Q000627:therapeutic use*
D000928:Antidepressive Agents; D014150:Antipsychotic Agents; D001549:Benzamides; D004338:Drug Combinations; D013881:Thioridazine; D020912:Moclobemide