A multicenter double-blind study of three different doses of the new cAMP-phosphodiesterase inhibitor rolipram in patients with major depressive disorder.
A multicenter randomized 4-week interindividual double-blind study was carried out in 58 hospitalized patients with major depressive disorder (DSM III 296.23, 296.22, 296.33, 296.32, 296.53 and 296.52) to test the dose-effect relationship of three different doses of the new cAMP-phosphodiesterase inhibitor rolipram: 3 x 0.25 mg, 3 x 0.50 mg and 3 x 1.00 mg rolipram/day. With respect to the desired effect, the 3 x 0.50 mg dosage stood out from the others in almost all relevant parameters. With respect to the response rate, the efficacy of the 3 x 0.25 mg dosage was about the same as that reported in the literature for placebo. The inferior performance of the 3 x 1.00 mg dosage compared to the 3 x 0.50 mg dosage might indicate a reverse U-shaped dose-effect relationship. There was good tolerance to all three dosages. There were no findings that might cast doubt on the safety of the dosages tested.
Fleischhacker
W W
WW
Department of Psychiatry, Innsbruck University Clinics, Austria.
Hinterhuber
H
H
Bauer
H
H
Pflug
B
B
Berner
P
P
Simhandl
C
C
Wolf
R
R
Gerlach
W
W
Jaklitsch
H
H
Sastre-y-Hernández
M
M
D000928:Antidepressive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011569:Psychiatric Status Rating Scales; D011760:Pyrrolidinones / Q000008:administration & dosage* / Q000009:adverse effects; D020889:Rolipram
D000928:Antidepressive Agents; D010726:Phosphodiesterase Inhibitors; D011760:Pyrrolidinones; D020889:Rolipram