A Controlled Study of Trazodone, Imipramine, and Placebo in Outpatients with Endogenous Depression

Mann, J. John; Γεωργοτασ, Αναστασιοσ; Newton, Roger E.; Gershon, Samuel

doi:10.1097/00004714-198103000-00006

Cited by 30 publications

(19 citation statements)

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“…These data arc not in agreement with the findings of Mann et al [1981] who observed that tolerance did not develop over 5 months neither to the antidepressant effect of trazo done nor to the inhibition of platelet sero tonin uptake.…”

Section: Pharmacodynamicscontrasting

confidence: 95%

“…Some investigators have reported that trazodone acts more rapidly, generally within the first week of treatment. This was observed by Agnoli et al [1975] in comparative studies with amitriptyline and desipramine, Kellams et al [ ], Feighner [1980, Mann et al [1981] and Bridges [1982] with imipramine. Pierce [1980] with dothiepin, Richards et al [1982] with mianserin and Lieto et al [1983] with nomifensine.…”

Section: Therapeutic Activitymentioning

confidence: 63%

“…Dry mouth is thought to be due to the adrenolytic activity of trazodone. The inci dence of anticholinergic side effects in 379 patients with endogenous depression treated with trazodone, imipramine or placebo are analyzed in figure 5 [ Gershon et al. 1981], Most importantly, there were no signifi cant differences between trazodone and pla cebo.…”

Section: Side Effectsmentioning

confidence: 99%

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Trazodone, a Review of Clinical Literature and Personal Experience

Agnoli¹,

Gregorio

Dionísio

1984

Psychopathology

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The authors summarize the international clinical research performed on trazodone, underlying some pharmacodynamic and therapeutic features of the activity of the drug, the originality of its pharmacodynamic profile and the possibility of using trazodone in a wide range of primary or secondary depression subtypes. Available data also suggest that trazodone is safer than traditional antidepressants even when taken in overdose, possibly due to its mild effects on cardiac or ventilatory function.

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Section: Pharmacodynamicscontrasting

confidence: 95%

Section: Therapeutic Activitymentioning

confidence: 63%

Section: Side Effectsmentioning

confidence: 99%

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Trazodone, a Review of Clinical Literature and Personal Experience

Agnoli¹,

Gregorio

Dionísio

1984

Psychopathology

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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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“…1968;De Gregorio and Dionisio, 1971;Agnoli et al, 1974: Cassano ct al.. 1974: Eckmann and Voelkel, 1976: Bonetti and Rizzoli, 1977Vinar et al, 1979;Murphy and Ankier, 1980] and then conclusively confirmed by extensive and well controlled clinical trials in the United States [Feighner, 1980;Gerner et al, 1980;Lapierre et al, 1980;Rickels et al, 1980;Feighner et al. 1981;Gershon et al, 1981;Gold berg et al, 1981;Mann et al. 1981].…”

Section: Dose3mentioning

confidence: 94%

Trazodone and the Mental Pain Hypothesis of Depression

Silvestrini¹

1986

Neuropsychobiology

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The mental pain hypothesis used to develop trazodone is illustrated, together with its medical and methodological implications. Trazodone possesses a well documented antidepressant activity, which indirectly confirms the above hypothesis. It lacks the aminergic effects of other antidepressants and has a marked adrenolytic activity. Therefore it is potentially indicated in depressive states with adrenergic hyperactivation, such as during alcohol withdrawal. The methodological aspects of the approach taken for trazodone are also discussed, in the context of the strategies of psychopharmacological research.

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A Controlled Study of Trazodone, Imipramine, and Placebo in Outpatients with Endogenous Depression

Cited by 30 publications

References 0 publications

Trazodone, a Review of Clinical Literature and Personal Experience

Trazodone, a Review of Clinical Literature and Personal Experience

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

Trazodone and the Mental Pain Hypothesis of Depression

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