[Randomized double-blind comparative study of the efficacy and tolerance of medifoxamine and imipramine in depressed patients].
Medifoxamine (Clédial TM), a non tricyclic non MAOI antidepressant drug with a dopaminergic and serotoninergic mechanism of action, was compared to imipramine in a multicenter double blind trial. Patients suffering from DSM III-R major depression (without psychotic features), with a minimum inclusion score of 25 at the MADRS after an initial 7-day wash-out period, were randomly assigned to a 4-week treatment by either imipramine or medifoxamine, with flexible doses of at least 100 mg after 2 weeks of treatment. No associated treatment was permitted except for lorazepam 2 to 5 mg per day. Ninety eight patients were recruited by 20 centers throughout France. Eighty four terminated the 4-week protocol. Early terminations were due to serious adverse events (3), death on imipramine (1), protocol violation (1), refusal to continue (1), loss to follow up (1). The 2 groups of patients were comparable on inclusion. In the medifoxamine group (receiving a daily dose of 194 mg at day 28) the percentage of improvement in MADRS scores, the number of patients with a MADRS improvement of a least 50% and a final MADRS score inferior to 8, were not significantly different from the imipramine group (daily dose: 161 mg at day 28). No more difference appeared when several clinical variables were analyzed, in particular the DSM III-R melancholic, the Newcastle endogenous subtypes and the in or out patient status. The two treatment groups were also comparable on other scales (HDRS, HARS assessing anxiety, CGI).(ABSTRACT TRUNCATED AT 250 WORDS)
Olié
J P
JP
Service Hospitalo-Universitaire de Santé Mentale et de Thérapeutique, Centre Hospitalier Sainte-Anne, Paris.
Galinowski
A
A
Lehert
P
P
Lemonnier
F
F
Lôo
H
H
D000328:Adult; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005021:Ethylamines / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007099:Imipramine / Q000009:adverse effects / Q000627:therapeutic use*; D008140:Lorazepam / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales
D000928:Antidepressive Agents; D005021:Ethylamines; C034065:medifoxamine; D008140:Lorazepam; D007099:Imipramine
Etude randomisée en double aveugle comparant l'efficacité et la tolérance de la médifoxamine et de l'imipramine chez des patients déprimés.