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

Author(s): Corruble, E.

Journal/Book: Eur Psychiat. 1997; 12: 141 Rue Javel, 75747 Paris Cedex 15, France. Editions Scientifiques Medicales Elsevier. 183-189.

Abstract: 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.

Note: Article Guelfi JD, Hop Paul Brousse, Dept Psychiat, 12-14 Ave P Vaillant Couturier, F-94804 Villejuif, FRANCE

Keyword(s): dysthymia; assessment tools; diagnostic criteria; clinical trials; MAJOR DEPRESSION; DEFENSE-MECHANISMS; COGNITIVE THERAPY; DISORDER; PERSONALITY; IMIPRAMINE; PHARMACOTHERAPY; COMORBIDITY; OUTPATIENTS; PREVALENCE

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