Research Evaluating Antidepressant Medications on Hospitalized Mental Patients

Wechsler, Henry; Grosser, G; Greenblatt, Milton

doi:10.1097/00005053-196508000-00012

Cited by 74 publications

(15 citation statements)

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“…30 A persistent concern with active-control designs is that the standard drug may be used in less-than-adequate dosages, 31 either at dosages that are too high, resulting in higher attrition from adverse effects, or dosages that are too low, resulting in less efficacy. Thus, the possibility of biasing a trial in favor of a new drug must be assiduously avoided.…”

Section: Active-control Designsmentioning

confidence: 99%

Clinical Research Designs for Emerging Treatments for Alzheimer Disease

1998

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The design of clinical trials must evolve as new therapies become available. The demonstrated efficacy and clinical use of donepezil and vitamin E for Alzheimer disease (AD) has shifted the options for AD research design. There is now a compelling case for alternatives to trials that include a treatment arm with no active therapy (ie, a placebo control). With an existing therapy, such as donepezil or vitamin E, new drugs that are clearly superior to those drugs should be sought. Combination therapy is a likely strategy for the future, implying that clinical trials, if possible, should replicate actual practice. The long duration of future AD trials also will make placebo-controlled trials more difficult to justify and more difficult to recruit for. Add-on or active-control designs represent the alternative approaches. We believe that definitive clinical trials of new AD drugs that use one or the other of these designs would be more likely to bring about therapeutic advances than would comparisons with inactive treatments. Our argument is not a general rejection of placebo-control designs. Our recommendations apply only to the circumstances in which the field of AD drug therapy now finds itself.

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Section: Active-control Designsmentioning

confidence: 99%

Clinical Research Designs for Emerging Treatments for Alzheimer Disease

1998

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“…In a methodological review of adult antidepressant outcome studies that set the standard for inquiry into the problem, Greenberg and others (Greenberg et al, 1992) emphasized the need to control researcher bias through rater and subject blindness. This recommendation was based on previous work that indicated an inverse relationship between the degree of blindness reported by researchers and the magnitude of reported effects (Greenberg & Fisher, 1989;Smith, Traganza, & Harrison, 1969;Wechsler, Grosser, & Greenblatt, 1965). In order to neutralize "vested interest" in antidepressant efficacy on the part of researchers, Greenberg and his colleagues (Greenberg et al, 1992;Greenberg & Fisher, 1989) recommended that response to tricyclic medications be assessed through a three-group design in which these drugs serve as a standard control group when one is comparing newer antidepressants to a placebo group.…”

Section: Degree Of Blindnessmentioning

confidence: 99%

A meta-analysis of antidepressant outcome studies that involved children and adolescents

et al. 1995

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A meta‐analysis was performed of available studies that document response to antidepressant medications in the pediatric population, based upon guidelines developed in a methodological review of adult antidepressant response (Greenberg, Borstein, Greenberg, & Fisher, 1992). The 27 studies accessed through standard medical and psychological data bases were assessed against the following criteria: degree of blindness, placebo group design, rating issues, sample size, inclusion criteria, and other methodological issues. Serious methodological flaws emerged in all areas, as well as an inverse relationship between positive findings and the presence of adequate experimental controls. Recommendations are made for improvements in experimental methodology, and caution is urged in the absence of well‐controlled studies.

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“…There are, however, several reviews of the use of clinical trials for the treatment of depression that use quantitative methods to summarize and compare trials. Examples are Smith et al (1969), Wechsler et al, (1969), Quality Assurance Project (1983), Conte et at. (1984) and Edward et al (1984).…”

Section: Role Ojmeta-analysismentioning

confidence: 99%

Statistics and the Nature of Depression

Dunn¹,

Sham²,

Hand³

1993

Journal of the Royal Statistical Society. Series A (Statistics

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A critical examination is made of the role that statistical methods have played in the understanding of depression. The development of instruments for measuring depression is illustrated by reference to the Beck depression inventory and the Hamilton rating scale. The controversy over the existence of one or two types of depression is examined from the perspective of the statistical tools used. Some of the problem in studies of the heritability of depression are outlined. The development of clinical trials of treatments for depression is examined, with particular reference to electroconvulsive therapy and maintenance therapy, and the role of meta-analysis is discussed.

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Research Evaluating Antidepressant Medications on Hospitalized Mental Patients

Cited by 74 publications

References 0 publications

Clinical Research Designs for Emerging Treatments for Alzheimer Disease

Clinical Research Designs for Emerging Treatments for Alzheimer Disease

A meta-analysis of antidepressant outcome studies that involved children and adolescents

Statistics and the Nature of Depression

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