A multicenter double-blind study of three different doses of the new cAMP-phosphodiesterase inhibitor rolipram in patients with major depressive disorder

Neuropsychobiology. 1992;26(1-2):59-64. doi: 10.1159/000118897.

Abstract

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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Antidepressive Agents / administration & dosage*
  • Antidepressive Agents / adverse effects
  • Depressive Disorder / drug therapy*
  • Depressive Disorder / psychology
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Humans
  • Phosphodiesterase Inhibitors / administration & dosage*
  • Phosphodiesterase Inhibitors / adverse effects
  • Psychiatric Status Rating Scales
  • Pyrrolidinones / administration & dosage*
  • Pyrrolidinones / adverse effects
  • Rolipram

Substances

  • Antidepressive Agents
  • Phosphodiesterase Inhibitors
  • Pyrrolidinones
  • Rolipram