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Methodological issues in the design of clinical studies of new drugs for the treatment of obsessive compulsive disorder

Published online by Cambridge University Press:  16 April 2020

RL Holland
RL Holland*
Affiliation:
Zeneca Pharmaceuticals, Mereside, Alderley Park, Macclesfield, SK10 4TG, UK
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Summary

Obsessive Compulsive Disorder (OCD) is increasingly recognised to be relatively common and responsive to some drug treatments (serotonin reuptake inhibitors). Clinical studies utilising recognised diagnostic criteria have identified some relevant negative prognostic factors: early age at disease onset, severe baseline disease, and failure of previous drug treatments all of which reduce the apparent success rates of SRI drugs. Furthermore, patients with comorbid tics seem to respond best to a combination of SRI activity and dopamine blockade. Short term efficacy studies are best performed with a parallel group design and a duration of around 3 months. Long term efficacy studies should probably use the relapse prevention design, with open label responders randomised to double blind continuation or placebo. Does finding has not been properly explored, and any one fixed dose will only be optimal for some patients. Efficacy can be reliably measured using the YBOCs, NIMH-OC and CGI rating scales.

Keywords

obsessive compulsive disorderclinical studiesmethodologyprognostic factorsrating scales
Type
Research Article
Information
European Psychiatry , Volume 12 , Issue S3 , 1997 , pp. 241s - 248s
Copyright
Copyright © Elsevier, Paris 1997

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References

Ackerman, DLGreenland, SBystritsky, AMorgernstern, HKatz, RJPredictors of Treatment Response in Obsessive-Compulsive Disorder: Multivariate Analyses from a Multicenter Trial of Clomipramine. J Clin Psychopharmacol 1994; 14: 247–254CrossRefGoogle ScholarPubMed
American Psychiatric Association Fourth Ed.Diagnostic and Statistical Manual of Mental Disorder 1994 American Psychiatric AssociationGoogle Scholar
Baer, LJenike, MABlack, DWTreece, Cet al.Effect of Axis II Diagnoses on Treatment Outcome with Clomipramine in 55 Patients with Obsessive-Compulsive Disorder Arch Gen Psychiatr 49 1992 862–866CrossRefGoogle ScholarPubMed
Bland, RCNewman, SCOrn, HPeriod Prevalence of Psychiatric Disorders in Edmonton. Acta Psychiatr Scand 77338s1988 33–42CrossRefGoogle Scholar
Chouinard, GGoodman, WKGreist, JJenike, Met al.Results of a Double-blind Placebo Controlled Trial of a New Serotonin Uptake Inhibitor, Sertraline, in the Treatment of Obsessive-Compulsive Disorder Psychopharmacol Bull 26 1990 279–284Google ScholarPubMed
Cottreaux, JMollard, EBouvard, MMarks, Iet al.A Controlled Study of Fluvoxamine and Exposure in Obsessive Compulsive Disorder Int Clin Psychopharmacol 5 1990 17–30CrossRefGoogle Scholar
Cottreaux, JMollard, EBouvard, MMarks, IExposure Therapy, Fluvoxamine, or Combination Treatment in Obsessive Compulsive Disorder: One Year Follow-up. Psychiat Res 1993; 49: 63–75CrossRefGoogle Scholar
De Vaugh-Geiss, JKatz, RLandau, PGoodman, WKRasmussen, SAClinical Predictors of Treatment Response in Obsessive-Compulsive Disorder: Exploratory Analyses from Multicentre Trials of Clomipramine. Psychopharmacol Bull 1990; 26: 54–59Google Scholar
Fernandez-Cordoba, ELopez-Ibor, AJLa monclorimpramina en enfermos psiquiatricos resistentes a otros tratamientos. Actas LusoEspan Neural Psiquiatr 1996; 726: 119–147Google Scholar
Flament, MWhitaker, ARapoport, JLDavies, Met al.Obsessive Compulsive Disorder in Adolescence: An Epidemiological Study J Am Acad Child Adolesc Psychiatry 27 1988 764–771CrossRefGoogle Scholar
Freeman, CPLTrimble, MRDeakin, JFWStokes, TMAshford, JJFluvoxamine Versus Clomipramine in the Treatment of Obsessive-Compulsive Disorder: A Multicentre, Randomised, Double-blind, Parallel Group Comparison. J Clin Psychiat 1994; 55: 301–305Google Scholar
Goodman, WKPrice, LHRasmussen, SAMasure, Cet al.The Yale Brown Obsessive Compulsive Scale (YBOCs), 1: Development, Use and Reliability; 2: Validity Arch Gen Psychiat 46 1989 1006–1016CrossRefGoogle Scholar
Goodman, WKPrice, LHDelgado, PLPalumbo, JSpecificity of Serotonin Reuptake Inhibitors in the Treatment of Obsessive-Compulsive Disorder. Comparison of Fluvoxamine and Desipramine. Arch Gen Psychiatry 1990; 47: 577–585CrossRefGoogle ScholarPubMed
Goodman, WKKozak, MJLiebowitz, MWhite, KLTreatment of Obsessive-Compulsive Disorder with Fluvoxamine: A Multicentre, Double-blind, Placebo Controlled Trial. Int Clin Psychopharmacol 1996; 11: 21–29CrossRefGoogle ScholarPubMed
Greist, JHJefferson, JWKobak, KAChouinard, Get al.A One Year Double-blind Placebo-Controlled Fixed Dose Study of Sertraline in the Treatment of Obsessive-Compulsive Disorder Int Clin Psychopharmacol 10 1995 57–65CrossRefGoogle ScholarPubMed
Greist, JHJefferson, JWKobak, KAKatzelnick, DJSerlin, RCEfficacy and tolerability of Serotonin Transport Inhibitors in Obsessive-Compulsive Disorder. Arch Gen Psychiat 1995; 52: 53–60CrossRefGoogle ScholarPubMed
Greist, JChouinard, GDuboff, EHalaris, Aet al.Double-blind Parallel Comparison of Three Dosages of Sertraline and Placebo in Outpatients with Obsessive-Compulsive Disorder Arch Gen Psychiat 52 1995 289–295CrossRefGoogle ScholarPubMed
Jenike, MAObsessive-Compulsive Disorder. Efficacy of Specific Treatments as Assessed by Controlled Trials. Psychopharmacol Bull 1993; 29: 487–499Google ScholarPubMed
Jenike, MABaer, LGreist, JHClomipramine Versus Fluoxetine in Obsessive-Compulsive Disorder: A Retrospective Comparison of Side Effects and Efficacy. J Clin Psychopharmacol 1990; 10: 122–124CrossRefGoogle ScholarPubMed
Katz, RJDe Vaugh-Geiss, JThe Anti-obsessional Effects of Clomipramine Do Not Require Concomitant Affective Disorder. Psychiatr Res 1990; 31: 121–129CrossRefGoogle Scholar
Katz, RJDe Vaugh-Geiss, JLandau, PClomipramine in Obsessive-Compulsive Disorder. Biol Psychiatr 1990; 28: 401–414CrossRefGoogle ScholarPubMed
Kim, SWDyksen, MWKuskowski, MThe Yale Brown Obsessive Compulsive Scale: A Reliability and Validity Study. Psychiat Res 1990; 34: 99–106CrossRefGoogle ScholarPubMed
Kim, SWDyksen, MWKushowski, MThe Symptom Checklist — 90: Obsessive Compulsive Subscale: A Reliability and Validity Study. Psychiat Res 1992; 41: 37–44CrossRefGoogle ScholarPubMed
Leonard, HSwedo, SKoby, ERapoport, JLet al.Treatment of Obsessive Compulsive Disorder with Clomipramine and Desmethylimpramine in Children and Adolescents: A Double-Blind Crossover Comparison Arch Gen Psychiatry 46 1989 1088–1092CrossRefGoogle Scholar
Marks, IDrug Versus Behavioural Treatment of Obsessive Compulsive Disorder. Biol Psychiat 1990; 28: 1065–1080CrossRefGoogle ScholarPubMed
Marks, ITreatment of Obsessive Compulsive Disorder. Brit J Psychiat 1995; 167: 411–412CrossRefGoogle ScholarPubMed
McDougle, CJGoodman, WKLeckman, JFBarr, LCet al.The Efficacy of Fluvoxamine in Obsessive-Compulsive Disorder: Effects of Comorbid Chronic Tic Disorder J Clin Psychopharmacol 13 1993 354–358CrossRefGoogle ScholarPubMed
McDougle, CJGoodman, WKLeckman, JFLee, NCet al.Haloperidol Addition in Fluvoxamine Refractory Obsessive-Compulsive Disorder Arch Gen Psychiat 51 1994 302–308CrossRefGoogle ScholarPubMed
Montgomery, SAMcIntyre, AOsterheider, MSarteschi, Pet al.A Double-blind Placebo Controlled Study of Fluoxetine in Patients with DSM III-R Obsessive-Compulsive Disorder European Neuropsychopharmacol 3 1993 143–152CrossRefGoogle ScholarPubMed
Murphy, DLPickar, DAlterman, ISMethods for the Quantitative Assessment of Depressive and Manic Behaviour. In: Burdock, ETSudilousky, AGersho, S eds. The Behavior of Psychiatric Patients. Washington DC: Marcel Dekker Inc, 1982; 355–391Google Scholar
Pato, MTZohar-Kadovich, RZohar, JMurphy, DLReturn of Symptoms After Discontinuation of Clomipramine in Patients with Obsessive-Compulsive Disorder. Am J Psychiat 1988; 145: 1521–1525Google ScholarPubMed
Pato, MTHill, JLMurphy, DLA Clomipramine Dosage Reduction Study in the Course of Long Term Treatment of Obsessive-Compulsive Disorder Patients. Psychopharmacol Bull 1990; 26: 211–214Google ScholarPubMed
Piccinelli, MPini, SBellantuono, CWilkenson, GEfficacy of Drug Treatment in Obsessive-Compulsive Disorder. A Metaanalytic Review. Brit J Psychiat 1995; 166: 424–443CrossRefGoogle Scholar
Rasmussen, SAEisen, JLEpidemiology of Obsessive Compulsive Disorder. J Clin Psychiatry 1990; 51s: 10–13Google Scholar
Riddle, MAScahill, LKing, RAHardin, MTet al.Double-blind Crossover Trial of Fluoxetine and Placebo in Children and Adolescents with Obsessive-Compulsive Disorder J Am Acad Child Adolesc Psychiatr 31 1992 1062–1069CrossRefGoogle ScholarPubMed
Robins, LNHelzer, JEWeissman, MMOrvaschel, Het al.Lifetime prevalence of specific psychiatric disorders in three sites Arch Gen Psychiatry 41 1984 958–967CrossRefGoogle ScholarPubMed
Saizruiz, JLopez-Ibor, JJCottreaux, IDouble-blind Comparison of Fluoxetine and Clomipramine in Obsessive-Compulsive Disorder. Eur Neuropsychopharmacol 1992; 2: 204–205CrossRefGoogle Scholar
Stein, DJSpadaccini, EHollander, EMetaanalysis of Pharmacotherapy Trials for Obsessive-Compulsive Disorder. Int Clin Psychopharmacol 1995; 10: 11–18CrossRefGoogle ScholarPubMed
Thenemann, MKorin, LMDo Soft Signs Predict Treatment Outcome in Obsessive-Compulsive Disorder?. J Neuropsychiat Clin Neurosci 1995; 7: 218–222Google Scholar
Tollefson, GDRamprey, AHPotvin, JHJenike, MAet al.A Multicentre Investigation of Fixed-dose Fluoxetine in the Treatment of Obsessive-Compulsive Disorder Arch Gen Psychiat 51 1994 559–567CrossRefGoogle Scholar
Tollefson, GDBirkett, MKoran, LGenduso, LContinuation Treatment of OCD: Double-blind and Open Label Experience with Fluoxetine. J Clin Psychiat 55(10s)1994 69–76Google ScholarPubMed
World Health Organization The ICD-10 Classification of Mental and Behavioural Disorders. Diagnostic Criteria for Research. New York: WHO Office of Publications, 1993Google Scholar
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