Hostname: page-component-78c5997874-4rdpn Total loading time: 0 Render date: 2024-11-10T14:24:37.578Z Has data issue: false hasContentIssue false
  • English
  • Français

A double-blind comparison of sertraline and clomipramine in outpatients with obsessive-compulsive disorder

Published online by Cambridge University Press:  16 April 2020

JC Bisserbe ,
RM Lane ,
MF Flament  and
France-Belgian OCD Study Group
JC Bisserbe
Affiliation:
Inserm, Charge de Recherche, Inserm U302, Hôpital de la Salpêtrière. 75013Paris, France
RM Lane
Affiliation:
Pfizer Inc, 235 East 42nd Street, New York, NY 10017-5755, USA
MF Flament
Affiliation:
Inserm, Charge de Recherche, Inserm U302, Hôpital de la Salpêtrière. 75013Paris, France
Get access

Summary

The aim of this study was to compare the efficacy, safety, and tolerability of sertraline and clomipramine in the treatment of obsessive-compulsive disorder (OCD). Outpatients with DSM-III-R defined OCD for 1 year or longer and scores of ≥ 20 on the YaleBrown Obsessive Compulsive Scale (Y-BOCS), ≥ 7 on the National Institute of Mental Health Global Obsessive-Compulsive Scale (NIMH-OC), ≥ 4 on the Clinical Global Impression Severity of Illness Scale (CGI-S) and ≤17 on the Hamilton Depression Scale (17 item HAMD) were randomized to sertraline (n = 86) or clomipramine (n = 82) once daily for 16 weeks. Initial daily doses of sertraline and clomipramine were 50 mg. After a minimum of 4 weeks, these doses could be increased by 50 mg increments every 2 weeks to a maximum of 200 mg daily if the response was thought inadequate. Efficacy was assessed at the end of 1, 2, 4, 6, 8, 12 and 16 weeks of therapy using the Y-BOCS, NIMH-OC, CGI-S, CGI Improvement Scale (CGI-I) and Clinical Anxiety Scale (CAS). One hundred sixty-eight patients were randomized and received at least one dose of double-blind medication; 86 received sertraline and 82 clomipramine. Mean final daily doses at final visit were clomipramine 90 mg (efficacy evaluable patients 101 mg, completers 110 mg), and sertraline 129 mg (efficacy evaluable patients 132 mg, completers 136 mg). Mean baseline Y-BOCS, NIMH-OC and CGI-S totals were 27.7, 10.1 and 5.5, respectively, for sertraline and 27.4, 9.9 and 5.5, respectively, for clomipramine. Sertraline demonstrated greater efficacy than clomipramine in the intent-to-treat patient group: mean baseline to final visit changes were 50.8% (Y-BOCS), 41.9% (NIMH-OC) and 37.7% (CGI-S) for sertraline and 42.9% (Y-BOCS), 33.8% (NIMH-OC) and 30.0% (CGI-S) for clomipramine (P < 0.05). The number of patients withdrawing because of adverse events was substantially greater for clomipramine (26%) than sertraline (11%) (P < 0.05). The most frequent adverse events for clomipramine were dry mouth (20%), anxiety (17%), constipation (16%), nausea (15%) and somnolence (11%), and for sertraline, diarrhea (12%) and nausea (12%). In this study, sertraline was more effective than clomipramine in the intent-to-treat analysis. The difference in efficacy between the treatments is almost wholly accounted for by a greater number of clomipramine withdrawals due to the poor patient acceptance of clomipramine. The superior tolerability of sertraline and the lower rate of premature treatment withdrawal relative to clomipramine may offer considerable quality of life and compliance benefits in the long-term management of a chronic disorder such as OCD.

Keywords

sertralineclomipramineobsessive-compulsive disorderY-BOCS
Type
Original article
Information
European Psychiatry , Volume 12 , Issue 2 , 1997 , pp. 82 - 93
Copyright
Copyright © Elsevier, Paris 1997

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Ananth, J, Elmishad, A, Wohl, M. Clomipramine vs fluoxetine in obsessive-compulsive disorder: an uncontrolled study. Adv Ther. 1993; 10: Nov–Dec 288–292Google Scholar
Beaumont, G. Sexual side-effects of clomipramine (Anafranil). J Int Med Res. 1973; 1: 469–472CrossRefGoogle Scholar
Beaumont, G. Sexual side-effects of clomipramine (Anafranil). J Int Med Res. 1977; 5: 37–44Google Scholar
Berken, GH, Weinstein, DO, Stern, WC. Weight gain: a side effect of tricyclic antidepressants. J Affective Disord. 1984; 7: 133–13810.1016/0165-0327(84)90031-4CrossRefGoogle ScholarPubMed
Chouinard, G, Goodman, W, Greist, J, et al.Results of a doubleblind placebo controlled trial of a new serotonin uptake inhibitor, sertraline, in the treatment of obsessive-compulsive disorder, Psychopharm Bull, 1990; 26: 279–284Google Scholar
Ciba-Geigy, . Review and evaluation of clinical data: Original New Drug Application 19-906 clomipramine (Anafranil) Summit, NJ 1989Google Scholar
The Clomipramine Collaborative Study Group Clomipramine in the treatment of patients with obsessive-compulsive disorder. Arch Gen Psychiatry. 1991; 48: 730–738CrossRefGoogle Scholar
Dickhaut, HH, Galiatsos, P. Neuartige Wege in der Pharmakotherapie von Verstimmungszuständen mit Anafranil. Nervenarzt. 1968; 39: 552–556Google Scholar
Doogan, DP, Caillard, V. Sertraline in the prevention of depression. Br J Psychiatry. 1992; 160: 217–22210.1192/bjp.160.2.217CrossRefGoogle ScholarPubMed
Flament, MF, Rapoport, JL, Berg, CJ, Sceery, W, Kilts, C, Mellstrom, AB, Linnoila, M. Clomipramine treatment of childhood obsessive compulsive disorder. Arch Gen Psychiatry. 1985; 42: 977–983CrossRefGoogle ScholarPubMed
Flament, MF, Rapoport, JL, Murphy, DL, Lake, CR, Berg, CJ. Biochemical changes during clomipramine treatment of childhood obsessive compulsive disorder. Arch Gen Psychiatry. 1987; 44: 219–22510.1001/archpsyc.1987.01800150025004CrossRefGoogle ScholarPubMed
Flament, MF, Whitaker, A, Rapoport, JL, et al.Obsessive compulsive disorder in adolescence: An epidemiological study. J Am Acad Child Adolescent Psychiatry. 1988; 27: 764–77110.1097/00004583-198811000-00018CrossRefGoogle Scholar
Frank, E, Kupfer, DJ, Bulit, CM, Levenson, JA. Imipramine and weight gain during the treatment of recurrent depression. J Affective Disord. 1993; 27: 139–145CrossRefGoogle Scholar
Freeman, CP, Trimble, MR, Deakin, JF, Stokes, TM, Ashford, JJ. Fluvoxamine versus clomipramine in the treatment of obsessive-compulsive disorder: a multicenter, randomized, double-blind, parallel group comparison. J Clin Psychiatry. 1994; 55: 301–305Google ScholarPubMed
Goodman, WK, Price, LH, Delgado, PL et al. Specificity of serotonin reuptake inhibitors in the treatment of obsessivecompulsive disorder: comparison of fluvoxamine and desipramine. Arch Gen Psychiatry. 1990; 47: 577–58510.1001/archpsyc.1990.01810180077011CrossRefGoogle Scholar
Greist, J, Chouinard, G, DuBoff, E, et al.Double-blind parallel comparison of three dosages of sertraline and placebo in outpatients with obsessive-compulsive disorder. Arch Gen Psychiatry. 1995; 52: 289–29510.1001/archpsyc.1995.03950160039008CrossRefGoogle ScholarPubMed
Greist, J, Jefferson, JW, Kobak, KA, et al.A one year double-blind placebo-controlled fixed dose study of sertraline in the treatment of obsessive-compulsive disorder. Int Clin Psychopharmacol. 1995; 10: 57–65CrossRefGoogle ScholarPubMed
Greist, J, Jefferson, JW, Kobak, KA, et al.Efficacy and tolerability of serotonin transport inhibitors in obsessive-compulsive disorder. Arch Gen Psychiatry. 1995; 52: 53–60CrossRefGoogle ScholarPubMed
Greist, JH, Jenike, MA, Robinson, D, Rasmussen, SA. Efficacy of fluvoxamine in obsessive-compulsive disorder: results of a multicentre double-blind, placebo-controlled trial. Eur J Clin Res. 1995; 7: 195–204Google Scholar
Hollander, E, McCarley, A. Yohimbine treatment of sexual side effects induced by serotonin reuptake blockers. J Clin Psychiatry. 1992; 53: 207–209Google ScholarPubMed
Jermain, DM, Crismon, ML. Pharmacotherapy of obsessive-compulsive disorder. Pharmacotherapy. 1990; 10: 175–198Google ScholarPubMed
Katz, RJ, DeVeaugh-Geiss, T, Landau, P. Clomipramine in obsessive-compulsive disorder. Biol Psychiatry. 1990; 28: 401–414CrossRefGoogle ScholarPubMed
Koran, LM, McElroy, SL, Davidson, JRT, Rasmussen, SA, Hollander, E, Jenila, MA. Double blind comparison of fluvoxamine and clomipramine in obsessive-compulsive disorder in the United States. Eur Neuropsychopharmacology. 1995; 5: 3371CrossRefGoogle Scholar
Kronig, MH, Apter, J, Asnis, G. A multicenter trial of sertraline for obsessive compulsive disorder. Poster presented at the 33rd Meeting of the American College of Neuropsychopharmacology, San Juan, Puerto Rico, 12–16 December 1994 Lopez-Ibor JJ. Ensayo clinico de la monochlorimipramina. (Clinical trial of clomipramine), Proceedings of the IVth World Congress Madrid, Spain 1966Google Scholar
Marks, IM, Stern, RS, Dawson, B, Cobb, J, McDonald, R. Clomipramine and exposure for obsessive-compulsive rituals: I. Br J Psychiatry. 1980; 136: 1–25CrossRefGoogle Scholar
McTavish, D, Benfield, P. Clomipramine. An overview of its pharmacological properties and a review of its therapeutic use in obsessive-compulsive disorder. Drugs. 1990; 39: Suppl 1 136–15310.2165/00003495-199039010-00010CrossRefGoogle Scholar
Monteiro, WO, Noshirvani, HF, Marks, IM, et al.Anorgasmia from clomipramine in obsessive-compulsive disorder: a controlled trial. Br J Psychiatry. 1987; 151: 107–112CrossRefGoogle ScholarPubMed
Montgomery, SA. Clomipramine in obsessional neurosis: a placebo controlled trial. Pharmaceut Med. 1980; 1: 189–192Google Scholar
Montgomery, SA, McIntyre, A, Osterheider, M. A double-blind, placebo controlled study of fluoxetine in patients with DSM-III-R obsessive-compulsive disorder. Eur Neuropsychopharmacology. 1993; 3: 143–15210.1016/0924-977X(93)90266-OCrossRefGoogle ScholarPubMed
Murdoch, D, McTavish, D. Sertraline. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in depression and obsessive-compulsive disorder. Drugs. 1992; 44: 604–624CrossRefGoogle ScholarPubMed
Picinelli, M, Pimi, S, Ballantuono, C, Wilkinson, G. Efficacy of drug treatment in obsessive-compulsive disorder. Br J Psychiatry. 1995; 166: 424–443CrossRefGoogle Scholar
Piggot, TA, Pato, MT, Bernstein, SE, Grover, AM, Hill, JL, Tolliver, TJ, Murphy, DL. Controlled comparisons of clomipramine fluoxetine in the treatment of obsessive-compulsive disorder Behavioral and biological results. Arch Gen Psychiatry. 1990; 47: 926–93210.1001/archpsyc.1990.01810220042005CrossRefGoogle Scholar
Preskorn, SH, Lane, RM. Sertraline 50mg daily —the optimal daily dose in depression. Int Clin Psychopharmacol. 1995; 10: 129–14110.1097/00004850-199510030-00001CrossRefGoogle Scholar
Rapoport, JL, Ryland, DH, Kriete, M. Drug treatment of canine acral lick disorder An animal model of obsessive-compulsive disorder. Arch Gen Psychiatry. 1992; 49: 517–521CrossRefGoogle ScholarPubMed
Rasmussen, S, Eisen, JL. Clinical and epidemiologic findings osignificance to neuropharmacologic trials in OCD. Psychopharm Bull. 1988; 24: 466–470Google ScholarPubMed
Rasmussen, S, Hackett, E, Duboff, E, et al.Long term sertraline in the treatment of obsessive compulsive disorder: a 2-year study. Eur Neuropsychopharmacology. 1995; 5: 3373CrossRefGoogle Scholar
Renynghe, de Voxrie GV. Anafranil (G 34586) in obsessive neurosis. Acta Neurol Belg. 1968; 68: 787–792Google Scholar
Saiz, Ruiz J, Lopez, Ibor JJ Jr, Cottreaux, J, et al.Double-blind comparison of fluoxetine and clomipramine in obsessive-compulsive disorder [abstract]. Eur Neuropsychopharmacol. 1992; 2: 204–205CrossRefGoogle Scholar
Smeraldi, E, Erzegovesi, S, Bianchi, I, et al.Fluvoxamine, v. clomipramine treatment in obsessive-compulsive disorder: a preliminary study. New Trends Exp Clin Psychiatry. 1992; 8: 63–65Google Scholar
Stein, DJ, Spadaccini, E, Hollander, E. Meta-analysis of pharmacotherapy trials for obsessive-compulsive disorder. Int Clin Psychopharmacology. 1995; 10: 11–1810.1097/00004850-199503000-00002CrossRefGoogle ScholarPubMed
Stoll, AL, Tohen, M, Baldessarini, RJ. Increasing frequency of the diagnosis of obsessive-compulsive disorder. Am J Psychiatry. 1992; 149: 638–640Google Scholar
Swedo, SE, Rapoport, JL, Leonard, H, et al.Obsessive-compulsive disorder in children and adolescents. Arch Gen Psychiatry. 1989; 46: 335–341CrossRefGoogle ScholarPubMed
Thoren, P, Asberg, M, Cronholm, B, Jornestedt, L, Traskman, L. Clomipramine treatment of obsessive-compulsive disorder. J A controlled clinical trial. Arch Gen Psychiatry. 1980; 37: 1281–1285CrossRefGoogle Scholar
Thoren, P, Asberg, M, Bertilsson, L, Mellstrom, B, Sjogvist, F, Traskman, L. Clomipramine treatment of obsessive-compulsive disorder. II Biochemical aspects. Arch Gen Psychiatry. 1980; 37: 1289–1294CrossRefGoogle ScholarPubMed
Tollefson, GD, Rampey, Jr AH, Potvin, JH, et al.A multicenter investigation of fixed-dose fluoxetine in the treatment of obsessive-compulsive disorder. Arch Gen Psychiatry. 1994; 51: 559–567CrossRefGoogle ScholarPubMed
Weissman, MM, Bland, RC, Canino, GJ, et al.The cross national epidemiology of obsessive-compulsive disorder. J Clin Psychiatry. 1994; 55: Suppl 35–10Google ScholarPubMed
Zohar, J, Insel, TR. Obsessive-compulsive disorder psychobiological approaches to diagnosis, treatment and pathophysiology. Biol Psychiatry. 1987; 22: 667–687CrossRefGoogle ScholarPubMed
Zohar, J, Mueller, EA, Insel, TR, et al.Serotonergic responsivity in obsessive-compulsive disorder: Comparison patients and healthy controls. Arch Gen Psychiatry. 1987; 44: 946–951CrossRefGoogle ScholarPubMed
Submit a response

Comments

No Comments have been published for this article.