title: A double-blind study of the efficacy and safety of sertraline and clomipramine in outpatients with severe major depression.
abstract: This study compared the efficacy and safety of the selective serotonin reuptake inhibitor sertraline with that of the tricyclic antidepressant clomipramine in patients with severe depression, as defined by a baseline 17-item Hamilton Depression Rating Scale (HAM-D) of at least 25. The study included 166 outpatients, randomized to double-blind treatment with sertraline (50-200 mg) or clomipramine (50-150 mg) for 8 weeks. The efficacy of both treatments was similar, 74% of patients in the sertraline group and 71% of clomipramine patients being classified as responders at the end-point, as defined by a Clinical Global Impression-Improvement (CGI-I) score of 1 or 2. Mean HAM-D scores fell from 29.8 at baseline to 12.3 at endpoint in the sertraline group, and from 29.6-12.7 in the clomipramine group. There were more withdrawals due to adverse events in the clomipramine group than in the sertraline group (17% versus 12%). Dry mouth, tremor, dizziness and constipation were all substantially more common in the clomipramine group, whereas diarrhoea/loose stools was more common in the sertraline group. Overall, sertraline was as effective as clomipramine in this group of severely depressed outpatients, and showed better tolerability.
authors.affiliation: Hôpital Fernand Widal, Paris, France.
authors.forename: J P
authors.initials: JP
authors.lastname: Lépine
authors.forename: J
authors.initials: J
authors.lastname: Goger
authors.forename: C
authors.initials: C
authors.lastname: Blashko
authors.forename: C
authors.initials: C
authors.lastname: Probst
authors.forename: M F
authors.initials: MF
authors.lastname: Moles
authors.forename: J
authors.initials: J
authors.lastname: Kosolowski
authors.forename: B
authors.initials: B
authors.lastname: Scharfetter
authors.forename: R M
authors.initials: RM
authors.lastname: Lane
mesh_terms: D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000929:Antidepressive Agents, Tricyclic / Q000008:administration & dosage / Q000627:therapeutic use*; D002997:Clomipramine / Q000008:administration & dosage / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D020280:Sertraline / Q000008:administration & dosage / Q000627:therapeutic use*; D012720:Severity of Illness Index; D012890:Sleep / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: D000928:Antidepressive Agents; D000929:Antidepressive Agents, Tricyclic; D002997:Clomipramine; D020280:Sertraline