PMID- 10993128 OWN - NLM STAT- MEDLINE DCOM- 20010118 LR - 20191025 IS - 0268-1315 (Print) IS - 0268-1315 (Linking) VI - 15 IP - 5 DP - 2000 Sep TI - A double-blind study of the efficacy and safety of sertraline and clomipramine in outpatients with severe major depression. PG - 263-71 AB - 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. FAU - Lepine, J P AU - Lepine JP AD - Hopital Fernand Widal, Paris, France. FAU - Goger, J AU - Goger J FAU - Blashko, C AU - Blashko C FAU - Probst, C AU - Probst C FAU - Moles, M F AU - Moles MF FAU - Kosolowski, J AU - Kosolowski J FAU - Scharfetter, B AU - Scharfetter B FAU - Lane, R M AU - Lane RM LA - eng PT - Clinical Trial PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PL - England TA - Int Clin Psychopharmacol JT - International clinical psychopharmacology JID - 8609061 RN - 0 (Antidepressive Agents) RN - 0 (Antidepressive Agents, Tricyclic) RN - NUV44L116D (Clomipramine) RN - QUC7NX6WMB (Sertraline) SB - IM MH - Adult MH - Aged MH - Antidepressive Agents/administration & dosage/*therapeutic use MH - Antidepressive Agents, Tricyclic/administration & dosage/*therapeutic use MH - Clomipramine/administration & dosage/*therapeutic use MH - Depressive Disorder/*drug therapy/psychology MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Middle Aged MH - Outpatients MH - Sertraline/administration & dosage/*therapeutic use MH - Severity of Illness Index MH - Sleep/drug effects MH - Treatment Outcome EDAT- 2000/09/19 11:00 MHDA- 2001/02/28 10:01 CRDT- 2000/09/19 11:00 PHST- 2000/09/19 11:00 [pubmed] PHST- 2001/02/28 10:01 [medline] PHST- 2000/09/19 11:00 [entrez] AID - 10.1097/00004850-200015050-00003 [doi] PST - ppublish SO - Int Clin Psychopharmacol. 2000 Sep;15(5):263-71. doi: 10.1097/00004850-200015050-00003.