A comparison of paroxetine and placebo in depressed outpatients

Dunbar, Geoffrey; Claghorn, James L.; Kiev, Ari; Rickels, Karl; Smith, Ward T.

doi:10.1111/j.1600-0447.1993.tb03376.x

Cited by 45 publications

(22 citation statements)

References 14 publications

(8 reference statements)

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“…Numerous clinical trials have assessed the effi cacy of antidepressants, generally indicating that antidepressant treatment of major depression is superior to placebo treatment (Dunbar et al 1993;Ellingrod and Perry 1995;Ballenger 1996;Croft et al 1999;Feighner and Overo 1999;Gorman 1999). The majority of studies that compare multiple antidepressants including SSRIs and tricyclic antidepressants (TCAs) show no signifi cant effi cacy differences between them (Holliday and Plosker 1993;Bennie et al 1995;Patris et al 1996;Sechter et al 1999;Stahl 2000;Kroenke et al 2001), but with very high sample size or with meta-analysis using data from multiple studies, TCAs and dual reuptake inhibitors show greater effi cacy than SSRIs (Thase 2002).…”

Section: Approaches To Mdd Treatmentmentioning

confidence: 99%

Duloxetine in the Treatment of Major Depressive Disorder

Goldstein

Mallinckrodt²,

Lü³

et al. 2002

J. Clin. Psychiatry

273

160

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Abstract:Since depression impacts all body systems, antidepressant treatments should relieve both the emotional and physical symptoms of depression. Duloxetine demonstrated antidepressant effi cacy at a dose of 60 mg qd in two placebo-controlled, randomized, double-blind studies and signifi cantly improved remission rates compared with placebo. Duloxetine-treated patients had signifi cant reduction in severity of the symptoms of depression as assessed by the HAM-D 17 , anxious symptoms as measured by the HAM-A and quality of life measures compared to placebo. Duloxetine also improved somatic symptoms, particularly painful symptoms which may have contributed to signifi cantly improved remission rates compared to placebo. Approximately 10% of the 1139 patients with major depressive disorder in placebo-controlled trials discontinued treatment due to an adverse event, compared to 4% of the 777 patients receiving placebo. In addition to nausea (1.4% incidence), which was the most common reason for discontinuation, dizziness, somnolence, and fatigue were the most common AEs reported as reasons for discontinuation and all were considered drug-related. Duloxetine treatment lacks effects on ECG, increases heart rate, and has little effect on blood pressure or weight.

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Section: Approaches To Mdd Treatmentmentioning

confidence: 99%

Duloxetine in the Treatment of Major Depressive Disorder

Goldstein

Mallinckrodt²,

Lü³

et al. 2002

J. Clin. Psychiatry

273

160

View full text Add to dashboard Cite

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“…It has a low side-effect profile, even at high doses. 1 Altough transient mild elevations of liver enzymes have been observed with use of paroxetine, 11,12 severe hepatoxicity is a rare condition and only ten cases were reported in the literature. Hepatotoxicity can be hepatocellular, cholestatic or mixed type.…”

Section: Discussionmentioning

confidence: 99%

Paroxetine Induced Toxic Hepatitis: Case Report

Akın¹,

Işler²,

Senol³

et al. 2012

Turkiye Klinikleri J Med Sci

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“…Functional measures: In accord with the renewed interest in "remission", i.e., the virtual absence of symptoms and restoration of social function, as an outcome index, as against response ( Ͼ 50% reduction in baseline symptomatology), recent evidence shows a place for measures of social functioning and quality of life Healy 1998;Bosc et al 1997). Studies have shown such measures to be sensitive to drug actions when symptom severity in itself was not (Dunbar et al 1991). Signs of social impairment in outpatient depressives can be subtle.…”

Section: Conceptions Of Depression and The Mechanisms Of Drug Actionmentioning

confidence: 99%

Enhancing the Technology of Clinical Trials and the Trials Model to Evaluate Newly Developed, Targeted Antidepressants

Katz

Halbreich

Bowden

et al. 2002

Neuropsychopharmacology

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Concern about disappointing results from recent multicenter trials of new antidepressants prompted several ACNP workshops on "improving the technology of clinical trials." The workshops focused on technical problems, such as patient screening, reliability of clinical ratings, and the role of the placebo control. They aimed to determine how to 27 , NO . 3 ducing adverse events, and lessening the complexity of dosing regimens. In addition, attention is currently focused on accelerating the onset of drug action to generate more rapidly acting antidepressants. Unfortunately, recently conducted multi-center clinical trials of some of these agents encountered serious technical problems and did not produce the results anticipated from preclinical studies. Although this may be partly due to limitations in extrapolating pre-clinical data to patients, it may also be that there are significant constraints in the current clinical trials model that make it difficult to demonstrate efficacy.The current clinical trials model is now 30 years old. The essential principles of randomization, double blind evaluation, and a placebo control remain sound. But other important aspects of the research design and the methodology are no longer sufficient or well suited to the testing of these new drugs. In effect, such deficiencies in current trial methodologies make it increasingly difficult to demonstrate antidepressant efficacy of these new drugs.One important reason the current model has proved inadequate is that it was initially applied to hospitalized depressed patients. Today new drugs are tested almost exclusively on outpatient samples, many of whom are symptomatic volunteers, responding to advertisements. Depressed outpatients have milder depressive symptomatology than the predominantly inpatient samples used to test the first established drugs. Patients with milder severity provide a narrower range of possible change, and produce a greater number of placebo responders (Fisher et al. 1965;Bowden et al. 2000;Khan et al. 2002).As a consequence of the smaller difference between active treatment and placebo treatment, larger patient samples and/or more sensitive clinical methods are needed to detect differences between drug and placebo. The most commonly utilized scales, the Hamilton Depression Rating Scale (HDRS) (Hamilton 1960) and the Clinical Global Impression Scale (CGI) (Guy 1976), were designed to measure changes in overall severity of the disorder. These scales are not sufficiently sensitive to assess the specific behavioral changes brought about by the newer drugs (Montgomery and Asberg 1979). Further, intensive evaluation of symptomatology and behavioral change are carried out infrequently with outpatients, making evaluation of rapidity of response problematic. Consequently, it appears important to improve the technology applied to assessing the specific actions, onset, and efficacy of the newer drugs.Acknowledging the increased complexity of the goals of clinical trials and the need to improve trial procedures, the desi...

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A comparison of paroxetine and placebo in depressed outpatients

Cited by 45 publications

References 14 publications

Duloxetine in the Treatment of Major Depressive Disorder

Duloxetine in the Treatment of Major Depressive Disorder

Paroxetine Induced Toxic Hepatitis: Case Report

Enhancing the Technology of Clinical Trials and the Trials Model to Evaluate Newly Developed, Targeted Antidepressants

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