Differential Response of Hospitalized Depressed Patients to Somatic Therapy

Greenblatt, Milton; Grosser, G; Wechsler, Henry

doi:10.1176/ajp.120.10.935

Cited by 237 publications

(71 citation statements)

References 3 publications

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“…11, NO. 1 Placebo Run-in for Antidepressant Trials 35 Feighner et al 1979;Goldberg and Finnerty 1980;Reimherr et al 1990;Rickels and Case 1982; Rowen et al 1982; Claghorn et al 1983;Hormazabal et al 1985; Irnlah 1985;Rickels et al 1985;Amsterdam et al 1986; Kleiser and Lehmann 1988;Spiker and Kupfer 1988Stewart et al 1981, 1985Veith et al 1982Jarvik et al 1983;Rickels et al 1985Agnew et al 1961Rothman et al 1962;Greenblatt et al 1964;Schildkraut et al 1964; British Medical Research Council 1965;Raskin et al 1978;Kellams et al 1979; Escobar et al 1980; Feighner 1980;Gerner et al 1980;Mann et al 1981;Rickels et al 1981; van der Velde 1981; Rickels et al 1982a,b;Veith et al 1982; Feighner et al 1983a,b; !til et al 1983;Jarvik et al 1983;Meredith and Feighner 1983a;Meredith et al 1984;Reimherr et al 1984; Liebowitz et al 1984a,b; Cohn and Wilcox 1985; Dominguez et al 1985;Kocsis et al 1985;Stark and Hardison 1985;Lipman et al 1986;Mendels and SchIess 1986; Wakelin 1986;Lapierre et al 1987;Rickels et al 1987; Byerley et al 1988;Liebowitz et al 1988;Quitkin et al 1988; Cohn et al. 1989; Conti and dell'Osso 1989; Elkin et al 1989; Feighner and Boyer 1989;Kocsis et al 1989;Lydiard et al 1989;Peselow et al 1989;…”

mentioning

confidence: 99%

Does a Placebo Run-In or a Placebo Treatment Cell Affect the Efficacy of Antidepressant Medications?

Trivedi

Rush

1994

Neuropsychopharmacol

168

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During the last decade, there has been an increasing use of a placebo run-in period prior to randomization to active treatments, or placebo in randomized controlled trials aimed at establishing acute phase antidepressant drug efficacy in patients with major depression. This procedure is thought to reduce response rates to placebo treatment after randomization, thereby increasing the drug-placebo difference. Metaanalyses of 101 studies reveal that a placebo run-in does not (1) lower the placebo response KEY WORDS: Depression; Placebo; Metaanalysis; Placebo run-in; Antidepressant medicationThe placebo run-in phase has become virtually stan dard practice in randomized controlled trials (RCTs) to test the efficacy of antidepressant medications in phase III and often phase IV studies. This single-blind phase usually lasts 3-14 days, followed by patients being ran domized to treatment. However, if patients show a meaningful symptomatic reduction (usually deflned as a20% to 25% improvement on a symptom rating scale), subjects are excluded from study. The implications of this practice have rarely been empirically evaluated.The rationale, based largely on intuition, is thought to reduce placebo responders post-randomization, thereby lowering post-randomization placebo response rates, and increasing differences between placebo and active treatments. Prien and Levine (1984) also sug- 655 Avenue of the Americas, New York, NY 10010 rate, (2) increase the drug-placebo difference, or (3) affect the drug response rate post-randomization in either inpatients or outpatients for any antidepressant drug group. If there is a post-randomization placebo treatment cell, drug response rates are unchanged or are slightly lower than if there is no placebo treatment cell for outpatients. These results suggest that a pill placebo run in provides no advantage in acute phase efficacy trials. [Neuropsychopharmacology 11:33-43, 1994J gested that the placebo run-in might eliminate rapid remitters, thereby reducing the need for post-randomiza tion placebo control treatment in some circumstances. The insuffi cient empirical data amassed to test these notions have not strongly supported the practice. Reim herr et al. (1989), in a retrospective reanalysiS, discov ered that the elimination of prerandomization placebo run-in "responders" reduced the drug-placebo differ ence from 30% to 25% in outpatients with major depres sion, and surprisingly, increased the placebo treatment response rates from 13% to 16%.Additional circumstantial data to question the value of this practice is from adult trials that have attempted to clinically characterize placebo responders. Outpa tients who "respond" during the placebo run-in tend to have longer episodes, a more chronic illness, a lower initial level of symptom severity, and are more likely nonendogenous. In comparison, patients who respond to placebo after randomization, tend to have shorter cur rent episodes and higher symptom severity at random ization (Fairchild et al. 1986;Rabkin et al. 1986Rabkin et al...

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confidence: 99%

Does a Placebo Run-In or a Placebo Treatment Cell Affect the Efficacy of Antidepressant Medications?

Trivedi

Rush

1994

Neuropsychopharmacol

168

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“…[82][83][84] In a small number of studies with reliable methodology, ECT was shown to be superior than moderate dosages of antidepressants. 85,86 In our research, an RCT 78 showed that ECT was better than paroxetine in the treatment of patients with non-responsive depression to two types of antidepressants. A meta-analysis by Pagnin et al 3 showed the ECT superiority not only as compared to the simulated ECT and placebo, but also compared to antidepressants in general, tricyclic antidepressants and inhibitors of monoamine oxidase inhibitors (MAOIs).…”

Section: Efficacymentioning

confidence: 74%

Evidências da eficácia da eletroconvulsoterapia na prática psiquiátrica

Moser

Lobato

Belmonte-de-Abreu

2005

Rev. psiquiatr. Rio Gd. Sul

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A eletroconvulsoterapia (ECT) consiste em tratamento biológico ainda não amplamente utilizado na prática psiquiátrica, devido aos inúmeros fatores que contribuem para uma resistência acerca do método. Objetivando sustentar, com embasamento científico, o emprego da ECT, agregamos evidências de sua eficácia, indicações, contra-indicações e efeitos adversos, advindas dos principais ensaios clínicos randomizados e meta-análises disponíveis na literatura médica atual sobre o tema (PubMed/MEDLINE, Cochrane).

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“…A first criticism can be directed at our study; indeed, we did omit to use a placebo in the neurotic group of depressed patients; yet there is no scientific evidence at hand that neurotic depressions respond better to antidepressant drugs than they do to a placebo (3,5,6). Therefore, another study has been designed and is being conducted at Prevost Institute.…”

Section: Discussionmentioning

confidence: 99%

A Double-Blind Comparative Study of Opipramol and Amitriptyline in Neurotic and Endogenous Depressions

Rajotte¹,

Bordeleau

Tétreault

et al. 1966

Canadian Psychiatric Association Journal

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A comparative double-blind study of two antidepressant drugs, opipramol and amitriptyline, had been undertaken in neurotic and endogenous depressions. It was to be carried out simultaneously in a well-staffed university clinic and in an understaffed mental hospital. The depression rating scale used was the one constructed by Wechsler et al. Criteria to differentiate both entities were those described by Kiloh and Garside. It was hoped; 1) to compare the efficacy of both drugs; 2) to compare differences in milieu in regard to the two types of depression and the drugs used; 3) to test the hypothesis, by means of comparing scores on the DRS, that there exists a difference between neurotic and endogenous depressions. The trial could not be completed because it was very difficult to find neurotic depressions at the state hospital and endogenous depressions at the university clinic. Although the results could not be compared in terms of both institutions and no conclusion could be drawn as to the efficacy of either drugs in neurotic depressions because of too small a sample, it was nevertheless shown that amitriptyline was significantly superior to opipramol in endogenous depressions. Some methodological flaws of the present study were pointed out, namely, the lack of placebo in the neurotic group, the drawback of a flexible posology and the short observation period (4 weeks). Explanations were propounded to explicate the sampling difference between the two psychiatric institutions.

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Differential Response of Hospitalized Depressed Patients to Somatic Therapy

Cited by 237 publications

References 3 publications

Does a Placebo Run-In or a Placebo Treatment Cell Affect the Efficacy of Antidepressant Medications?

Does a Placebo Run-In or a Placebo Treatment Cell Affect the Efficacy of Antidepressant Medications?

Evidências da eficácia da eletroconvulsoterapia na prática psiquiátrica

A Double-Blind Comparative Study of Opipramol and Amitriptyline in Neurotic and Endogenous Depressions

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