Meta-Analysis of Placebo Response in Adult Antidepressant Trials

Li, Fenghua; Nasir, Madeeha; Olten, Baris; Bloch, Michael H.

doi:10.1007/s40263-019-00662-y

Cited by 29 publications

(24 citation statements)

References 27 publications

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“…Efficacy, compared to placebo, has been demonstrated for nortriptyline, venlafaxine extended release, desipramine, citalopram, and paroxetine, although the time course of the antidepressant response has differed. For example, nortriptyline demonstrated superiority to placebo in the short term ( i.e ., after 8 weeks) [ 126 , 127 ]. With this respect, identification of the long-term effects of maintenance treatment is critical; antidepressant treatment trials in all populations typically have a prominent placebo response, but the early placebo response is generally not sustained.…”

Section: Discussionmentioning

confidence: 99%

Drug Choices and Advancements for Managing Depression in Parkinson's Disease

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Pellicano

Savini

et al. 2020

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: Depression is a frequent non-motor symptom of Parkinson’s disease (PD), and may even precede the onset of motor symptoms of parkinsonism. Beyond its negative influence on mood, depression in PD is frequently associated with other neuropsychiatric symptoms and with late-stage complications such as dementia. Despite its profound impact on the quality of life and cognitive functioning in PD, depression in PD is often under-recognized and poorly treated. : Pathophysiological studies demonstrated that depression in PD is associated with global dysfunction of interactions between discrete brain areas rather than focal structural or functional abnormalities, and that it is sustained by pathological changes of several neurotransmitter/receptor complexes. : In general, all traditional antidepressants and some dopamine agonists have been found to be safe and well-tolerated to treat depressive symptoms in PD, despite initial warning on worsening of parkinsonism. Available data suggest that the time-course of response differs among antidepressants. Efficacy results from clinical trials with antidepressant in PD are, however, rather uncertain, although pooled analysis suggests a moderate benefit. Several issues may critically impact the results of clinical trials with antidepressants in PD, including the correct psychiatric diagnosis, the overlap of symptoms between depression and PD, and the selection of appropriate end-points and rating scales.

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Section: Discussionmentioning

confidence: 99%

Drug Choices and Advancements for Managing Depression in Parkinson's Disease

Assogna

Pellicano

Savini

et al. 2020

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“…There were some deviations between model predictions and observations when predicting long-term placebo response in mild-to-moderate AD subjects ((Additional file Figure 4). Finally, the time lag between recruitment of AD patients into clinical trials and the published year might interfere with drawing the conclusion of the publication year effect [37].…”

Section: Discussionmentioning

confidence: 99%

Testing whether the progression of Alzheimer's disease change with the year of publication, additional design and geographical area: a modeling analysis of literature aggregate data

zhang

Zheng

Liu

et al. 2020

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Background Our objective was to develop a disease progression model for cognitive decline in Alzheimer’s disease (AD) and to determine whether disease progression of AD is related to the year of publication, add-on trial design, and geographical regions. Methods Placebo-controlled randomized AD clinical trials were systemically searched in public databases. Longitudinal placebo response (mean change from baseline in the cognitive subscale of the Alzheimer’s Disease Assessment Scale [ADAS-cog]) and the corresponding demographic information were extracted to establish a disease progression model. Covariate screening and subgroup analyses were performed to identify potential factors affecting the disease progression rate. Results A total of 134 publications (140 trials) were included in this model-based meta-analysis. The typical disease progression rate was 5.82 points per year. The baseline ADAS-cog score was included in the final model using an inverse-U type function. Age was found to be negatively correlated with disease progression rate. After correcting the baseline ADAS-cog score and the age effect, no significant difference in disease progression rate was found between trials published before and after 2008, and between trials using add-on design and those that did not use add-on design. However, a significant difference was found among different trial regions. Trials in East Asian countries showed the slowest decline rate and the largest placebo effect. Conclusions Our model successfully quantified AD disease progression by integrating baseline ADAS-cog score and age as important predictors. These factors and geographic location should be considered when optimizing future trial designs and conducting indirect comparisons of clinical outcomes.

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“…Both models produce nearly identical scores for participants. If replicated in other studies, this finding suggests that the use of reflective latent variable models should be considered more carefully: what are the specific benefits of this modeling framework for the p factor literature, and do they outweigh the potential costs, such as over-parameterization and stringent assumptions imposed on the data 3,4 ? Such deliberations will benefit from explicit goals to determine whether specific statistical models are adequate in the context of a given research question.…”

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confidence: 90%

“…I would not expect a difference in outcome because a relatively large group of patients will respond to the non-specific aspects of treatment, no matter how they are assessed and diagnosed. In psychiatric practice, where the vast majority of patients are prescribed medication, the placebo effect accounts for much of the response to pharmacological intervention 4 . In placebo-controlled studies of major depressive disorder, bipolar disorder, schizophrenia, obsessive-compulsive disorder and anxiety disorders, it can be conservatively estimated that there is a 30% placebo response rate [4][5][6][7][8] .…”

Section: Why Hierarchical Dimensional Approaches To Classification Wimentioning

confidence: 99%

“…But let us not lose sight of the fact that p is an effect that needs to be explained (i.e., explanandum), not something that does the explaining (i.e., explanans). It necessarily emerges from a positive manifold, and tells us nothing about the mechanisms that generated the data 4,6 . Further, if the goal is the description of data, it is unclear why the reflective latent variable model that is solely relied upon in the literature should be the only model suited for this goal.…”

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confidence: 99%

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