Evidence map›Paper›PMID 27378326›Full record

Trial reportHuman psychopharmacology2016

Altruism, personal benefit, and anxieties: a phenomenological study of healthy volunteers' experiences in a placebo-controlled trial of duloxetine.

Isaac N Kwakye, Matthew Garner, David S Baldwin, Susan Bamford, Verity Pinkney, Felicity L Bishop

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Human psychopharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 30% of its field
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

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Trial
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

6 authors at 2 institutions in 2 countries.

Isaac N KwakyePsychology, Faculty of Social and Human Sciences, University of Southampton, Southampton, UK.
Matthew GarnerPsychology, Faculty of Social and Human Sciences, University of Southampton, Southampton, UK.
David S BaldwinClinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
Susan BamfordPsychology, Faculty of Social and Human Sciences, University of Southampton, Southampton, UK.
Verity PinkneyPsychology, Faculty of Social and Human Sciences, University of Southampton, Southampton, UK.
Felicity L BishopPsychology, Faculty of Social and Human Sciences, University of Southampton, Southampton, UK.
University of Southampton · GBUniversity of Cape Town · ZA

Funding

Medical Research Council MR/J011754/1
6 · The paper itself

Abstract

objectiveThe objective of this study was to develop an in-depth understanding of healthy volunteers' experiences of mental health trials.

methodsA qualitative study was nested within a healthy volunteer placebo-controlled trial of duloxetine, a psychotropic drug used for treating patients with major depression and generalized anxiety disorder. Eight participants were interviewed, and data were analyzed using interpretative phenomenological analysis.

resultsInterviewees described volunteering for the trial because they were interested in research, wanted the monetary incentive, wanted to help researchers, and wanted to be part of something. On entering the trial, participants considered the possible risks and described feeling anxious, excited, and determined; they had some clear expectations and some loosely held hopes about what would happen. During the trial, participants were curious about whether they were taking duloxetine or placebo, self-monitored their bodies' reactions, and guessed which treatment they received. On being un-blinded to treatment allocation after completing the trial, some participants' guesses were confirmed, but others were surprised, and a few were disappointed.

conclusionsSmall changes to advertising/consent materials to reflect volunteers' motivations could improve recruitment rates to similar trials; "active" placebos might be particularly useful for maintaining blinding in healthy volunteer trials; and sensitive procedures are needed for un-blinding participants to treatment allocation. Copyright © 2016 John Wiley & Sons, Ltd.

Indexed as

AltruismAdultAntidepressive AgentsAnxietyDuloxetine HydrochlorideFemaleHealthy VolunteersHumansMalePatient SelectionSerotonin and Noradrenaline Reuptake InhibitorsYoung AdultAntidepressive AgentsDuloxetine HydrochlorideSerotonin and Noradrenaline Reuptake Inhibitorshealthy volunteersmental healthplacebo effectpsychopharmacologyqualitative research

Identifiers

PMID27378326
PMCPMC4988510
OpenAlexW2462115548

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.