Evidence map›Paper›PMID 21651312›Full record

ArticleClinical pharmacokinetics2011

Structural models describing placebo treatment effects in schizophrenia and other neuropsychiatric disorders.

Venkatesh Pilla Reddy, Magdalena Kozielska, Martin Johnson, An Vermeulen, Rik de Greef, Jing Liu, Geny M M Groothuis, Meindert Danhof, Johannes H Proost

Abstract read
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In one paragraph

Article in Clinical pharmacokinetics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  16. Continuous-time Markov modelling of flexible-dose depression trials.Journal of pharmacokinetics and pharmacodynamics · 2014
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Venkatesh Pilla ReddyDepartment of Pharmacokinetics, Toxicology and Targeting, University Centre for Pharmacy, University of Groningen, Groningen, The Netherlands.
Magdalena Kozielska
Martin Johnson
An Vermeulen
Rik de Greef
Jing Liu
Geny M M Groothuis
Meindert Danhof
Johannes H Proost

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Large variation in placebo response within and among clinical trials can substantially affect conclusions about the efficacy of new medications in psychiatry. Developing a robust placebo model to describe the placebo response is important to facilitate quantification of drug effects, and eventually to guide the design of clinical trials for psychiatric treatment via a model-based simulation approach. In addition, high dropout rates are very common in the placebo arm of psychiatric clinical trials. While developing models to evaluate the effect of placebo response, the data from patients who drop out of the trial should be considered for accurate interpretation of the results. The objective of this paper is to review the various empirical and semi-mechanistic models that have been used to quantify the placebo response in schizophrenia trials. Pros and cons of each placebo model are discussed. Additionally, placebo models used in other neuropsychiatric disorders like depression, Alzheimer's disease and Parkinson's disease are also reviewed with the objective of finding those placebo models that could be useful for clinical studies of both acute and chronic schizophrenic disease conditions. Better understanding of the patterns of dropout and the factors leading to dropouts are crucial in identifying the true placebo response. We therefore also review dropout models that are used in the development of models for treatment effects and in the optimization of clinical trials by simulation approaches. The use of an appropriate modelling strategy that is capable of identifying the potential sources of variable placebo responses and dropout rates is recommended for improving the sensitivity in discriminating between the effects of active treatment and placebo.

Indexed as

Models, StatisticalPlacebo EffectHumansMental DisordersPatient DropoutsPlacebosSchizophreniaTreatment OutcomePlacebos

Identifiers

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.