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Methodological issues raised by clinical trials on dysthymia: assessment instruments and response criteria

Published online by Cambridge University Press:  16 April 2020

J.D. Guelfi
Affiliation:
Department of Psychiatry, Paul Brousse Hospital, 12-14 Avenue P Vaillant-Couturier94804Villejuif cedex, France
E Corruble
Affiliation:
Department of Psychiatry, Paul Brousse Hospital, 12-14 Avenue P Vaillant-Couturier94804Villejuif cedex, France
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Summary

Dysthymia clinical trials raise several methodological issues. The validity of the concept remains a matter of concern, as does the need for specific instruments, the difficulties in assessment of change and long-term assessments. Diagnostic criteria for inclusion should be used in a polydiagnostic approach. This paper summarises the main assessment tools and diagnostic criteria used in clinical trials on dysthymia. Severity criterion for inclusion could be a Hamilton Depression Rating Scale score (HAMD-17) between 13 and 17. The main response criteria should be a decrease of at least 50% of the total score on this scale and a final score under a predetermined limit. However, other response criteria may be useful: depression self-ratings, global assessments, general psychopathology assessments, personality and defense mechanisms, quality of life, psychosocial and functional impairment, diagnostic criteria (presence or absence) and side-effect assessment.

Type
Research Article
Copyright
Copyright © Elsevier, Paris 1997

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References

Akiskal, HSClinical subtypes of chronic-resistant depressionIn: Feighner, JPBoyer, WFeds. The diagnosis of depression 1991 J Wiley and Sons Ltd New York150162Google Scholar
APA, Second EditionDiagnostic and Statistical Manual of Mental Disorders 1968 American Psychiatric Association Washington DCGoogle Scholar
APA, Third EditionDiagnostic and Statistical Manual of Mental Disorders 1980 American Psychiatric Association Washington DCGoogle Scholar
APA, Revised Third EditionDiagnostic and Statistical Manual of Mental Disorders 1987 American Psychiatric Association Washington DCGoogle Scholar
APA, Fourth EditionDiagnostic and Statistical Manual of Mental Disorders 1994 American Psychiatric Association Washington DCGoogle Scholar
Andrews, GSingh, MBond, MThe defense style questionnaire J Nerv Ment Dis 181 1993 246256CrossRefGoogle ScholarPubMed
Angst, JWicki, WThe Zürich Study: Is dysthymia a separate form of depression? Results of the Zürich cohort study Eur Arch Psychiatry Clin Neurosci 240 1991 349354CrossRefGoogle ScholarPubMed
Bakish, DLapierre, YDWeinstein, Ret al. Ritanserine, imipramine and placebo in the treatment of dysthymic disorder J Clin Psychopharmacol 13 1993 409414CrossRefGoogle Scholar
Beck, ATDepression Inventory 1978 Center for Cognitive Therapy PhiladelphiaGoogle Scholar
Bloch, ALShear, MKMarkowitz, JCet al. An empirical study of defense mechanisms in dysthymia Am J Psychiatry 150 1993 11941198Google ScholarPubMed
Bond, MPerry, JCGautier, Met al. Validating self-report of defense styles J Pers Disord 3 1989 101112CrossRefGoogle Scholar
de Jong, RTreiber, RHenrich, GEffectiveness of two psycho-logical treatments for inpatients with severe and chronic depressions Cognitive Ther Res 10 1986 645663CrossRefGoogle Scholar
Derogatis, LRLipman, RSRickels, Ket al. The Hopkins Symptom Check List (HSCL): a self-report symptom inventory Behav Sci 19 1974 115CrossRefGoogle Scholar
Derogatis, LRSCL-90R (revised) version Manual 1 1977 Clinical Psychometrics Research Unit, John Hopkins University School of Medicine BaltimoreGoogle Scholar
Frances, ARecurrent brief depression, dysthymia and melancholia Int Clin Psychopharmacol 7 1993 197200CrossRefGoogle ScholarPubMed
Frances, AKocsis, JMarin, Det al. Diagnosis criteria for dysthymic disorder Psychopharmacol Bull 25 1989 325329Google ScholarPubMed
Frank, EPrien, RFJarett, RBet al. Conceptualization and rationale for consensus definitions of terms in major depressive disorder Arch Gen Psychiatry 48 1991 851855CrossRefGoogle ScholarPubMed
Guelfi, J.D.Pichot, PDreyfus, JFEfficacy of tianeptine in anxious-depressed patients: results of a controlled multicenter trial versus amitriptyline Neuropsychobiology 22 1989 4148CrossRefGoogle ScholarPubMed
Guelfi, J.D.Clinical research in psychopharmacology: new standards for drug development. An application to antidepressants Psychiatr Psychobiol 5 1990 289294CrossRefGoogle Scholar
Guelfi, J.D.L'échelle de dépression de HamiltonIn: Guelfi, J.D.eds. L'évaluation clinique standardisée en Psychiatrie TomeI 1993 Editions Médicales Pierre Fabre BoulogneGoogle Scholar
Gwirtsman, HEOverview of the diagnosis, prevalence and comorbidity of dysthymia Psychopharmacol Bull 30 1994 4551Google ScholarPubMed
Harpin, RELiberman, RPMarks, IStern, RBohannon, WECognitive behavior therapy for chronically depressed patients: a controlled pilot study J Nerv Ment Dis 170 1982 295301CrossRefGoogle ScholarPubMed
Hellerstein, DJYanowitch, PRosenthal, Jet al. A randomized double-blind study of fluoxetine versus placebo in the treat-ment of dysthymia Am J Psychiatry 150 1993 11691175Google Scholar
Hirschfeld, RMAHolzer, CEDepressive personality disorder: clinical implications J Clin Psychiatry 55 1994 S10S17Google ScholarPubMed
Keller, MBCourse, outcome and impact on the community Acta Psychiatry Scand 89 1994 S24S34CrossRefGoogle Scholar
Keller, MBLavori, PWDouble depression, major depression and dysthymia: distinct entities or different phases of a single disorder? Psychopharmacol Bull 20 1984 399402Google ScholarPubMed
Keller, M.B.Shapiro, R.W.“Double depression”: superimposition of acute depressive episodes on chronic depressive disorders Am. J. Psychiatry 139 1982 438442Google ScholarPubMed
Keller, MBKlein, DNHirschfeld, RMAet al. Results of the DSM-IV Mood Disorders Field Trial Am J Psychiatr 152 1995 843849Google ScholarPubMed
Klein, DNDepressive personality: reliability, validity and relation to dysthymia J Abn Psychol 99 1990 412421CrossRefGoogle ScholarPubMed
Klerman, GLWeissman, MMFrank, Eet al. Evaluating drug treatments of depressive disordersIn: Prien, RFRobinson, DSeds. Clinical Evaluation of Psychotropic Drugs: Principles and Guidelines 1994 Raven Press Ltd New York281325Google Scholar
Kocsis, JHFrances, AJA critical discussion of DSM-III dysthymic disorder Am J Psychiatry 144 1987 15341542Google ScholarPubMed
Kocsis, JHFrances, AJVoss, Cet al. Imipramine treatment for chronic depression Arch Gen Psychiatry 45 1988 253257CrossRefGoogle ScholarPubMed
Kocsis, JHThase, MEKoran, Let al. Pharmacotherapy for “pure” dysthymia: sertraline versus imipramine and placebo Eur Neuropsychopharmacol 4 1994 S204s2CrossRefGoogle Scholar
Lapierre, YDPharmacological therapy of dysthymia Acta Psychiatr Scand 89 1994 S42S48CrossRefGoogle Scholar
Lecrubier, YPharmacological interventions in dysthymia Eur Psychiatry 11Suppl 31996 129s133sCrossRefGoogle Scholar
Lopez Ibor, JJFrances, AJones, CDysthymic disorder: a com-parison of DSM-IV and ICD-10 and issues in differential diagnosis Acta Psychiatr Scand 89 1994 S12S18CrossRefGoogle Scholar
MacCullough, JPPsychotherapy for dysthymia: a naturalistic study of ten patients J Nerv Ment Dis 179 1991 734740CrossRefGoogle Scholar
MacCullough, JPMacCune, KJKaye, ALet al. Comparison of a community dysthymia sample at screening with a matched group of nondepressed community controls J Nerv Ment Dis 182 1994 402407CrossRefGoogle Scholar
Marin, DBKocsis, JHFrance, AJParides, MDesipramine for the treatment of “pure” dysthymia versus “double” depression Am J Psychiatry 151 1994 10791080Google ScholarPubMed
Markowitz, JCPsychotherapy of dysthymia Am J Psychiatry 151 1994 11141121Google ScholarPubMed
Mason, BJMarkowitz, JCKlerman, GLInterpersonal psychotherapy for dysthymic disordersIn: Klerman, GLWeissman, MMNew Applications of Interpersonal Therapy 1993 American Psychiatric Press WashingtonGoogle Scholar
Mercier, MAStewart, JWQuitkin, FMA pilot sequential study of cognitive therapy and pharmacotherapy of atypical depression J Clin Psychiatry 53 1992 166170Google ScholarPubMed
Montgomery, SAAsberg, MA new depression scale designed to be sensitive to change Br J Psychiatry 134 1979 382389CrossRefGoogle ScholarPubMed
Osser, DNA systematic approach to the classification and pharmacotherapy of nonpsychotic major depression and dysthymia J Clin Psychopharmacol 13 1993 133144CrossRefGoogle ScholarPubMed
Pepper, CMKlein, DNAnderson, RLet al. DSM-III-R axis II comorbidity in dysthymia and major depression Am J Psychiatry 152 1995 239247Google ScholarPubMed
Perry, JCCooper, SHAn empirical study of defense mechanisms Arch Gen Psychiatry 46 1989 444452CrossRefGoogle ScholarPubMed
Rotter, JBGeneralized Expectancies for Internal versus External Control of Reinforcement Psychological Monographs N∘ 609 1966CrossRefGoogle Scholar
Rush, AJGiles, DESchlesser, MAet al. The Inventory for Depressive Symptomatology: Preliminary findings Psychiatr Res 18 1985 6567CrossRefGoogle Scholar
Sanderson, WCWetler, SBeck, ATBetz, FPrevalence of personality disorders in patients with major depression and dysthymia Psychiatr Res 42 1992 9399CrossRefGoogle ScholarPubMed
Stewart, JHMacGrath, PJLiebowitz, MRet al. Treatment outcome validation of DSM-III depressive subtypes Arch Gen Psychiatry 42 1985 11481153CrossRefGoogle ScholarPubMed
Stewart, JWQuitkin, FMMcGrath, PJet al. Social functioning in chronic depression: effects of 6 weeks of antidepressant treatment Psychiatry Res 25 1988 213222CrossRefGoogle Scholar
Stravynski, AShahar, JWQuitkin, FMA pilot study of the cognitive treatment of dysthymic disorder Behavioural Psychotherapy 4 1991 369372CrossRefGoogle Scholar
Tyrer, PSeivewright, NFerguson, Bet al. The Nottingham Study of neurotic disorder Br J Psychiatry 162 1993 219226CrossRefGoogle ScholarPubMed
Vallejo, JGasto, CCatalan, RSalamero, MDouble-blind study of imipramine versus phenelzine in melancholias and dysthymic disorders Br J Psychiatry 151 1987 639642CrossRefGoogle ScholarPubMed
Versiani, MNardi, ECapponi, RMoclobemide compared with imipramine in the treatment of chronic depression (dysthymia DSM-III-R): a double-blind placebo controlled trial Clin Neuropharmacol 15 1992 148149Google Scholar
Waintraub, LGuelfi, JD. The validity of the concept of dysthymia. Eur Psychiatry, in pressGoogle Scholar
Weissman, MMPrusoff, BAThomson, WDet al. Social adjustements by self-report in a community sample and in psychiatric outpatients J Nerv Ment Dis 166 1978 317326CrossRefGoogle Scholar
Weissman, MMLeaf, PJBruce, MLFlorio, LThe epidemiology of dysthymia in five communities: rates risks, comorbidity and treatment Am J Psychiatry 145 1988 815819Google ScholarPubMed
World Health Organization, Mental Disorders: Nineth revision of the International Classification of Diseases 1978 WHO GenevaGoogle Scholar
World Health Organization, Mental Disorders: Tenth revision of the International Classification of Diseases 1992 WHO GenevaGoogle Scholar
Zung, WWKA self-rating depression scale Arch Gen Psychiatry 12 1965 63CrossRefGoogle ScholarPubMed
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