Evidence map›Paper›PMID 25006812›Full record

ArticleThe Journal of clinical psychiatry2014

The role of patient expectancy in placebo and nocebo effects in antidepressant trials.

Bret R Rutherford, Melanie M Wall, Andrew Glass, Jonathan W Stewart

Abstract read
In one paragraph

Article in The Journal of clinical psychiatry, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 3 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

14 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  12. The evidence-based group-level symptom-reduction model as the organizing principle for mental health care: time for change?World psychiatry : official journal of the World Psychiatric Association (WPA) · 2019
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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

4 authors.

Bret R RutherfordColumbia University College of Physicians and Surgeons, Department of Psychiatry, New York State Psychiatric Institute, 1051 Riverside Drive, Box 98, New York, NY 10032 brr8@columbia.edu.
Melanie M Wall
Andrew Glass
Jonathan W Stewart

Funding

Placebo Effects in the Treatment of Depression: Cognitive and Neural MechanismsK23MH085236 · NIMH · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · PI RUTHERFORD, BRET R · 2010 to 2014
$883k
NIMH NIH HHS K23 MH085236
6 · The paper itself

Abstract

objectiveTo determine whether patient expectancy plays a role in observed placebo and nocebo effects in 2 clinical trials.

methodData were reanalyzed from 2 fluoxetine-discontinuation studies conducted from March 1990 to September 1992 and from May 1997 to December 2002. The 673 outpatients included were aged 18-65 years with DSM-III-R major depressive disorder (MDD), responded to 12-week duration open treatment, and were randomized to continued fluoxetine or placebo for an additional year. Participants in 1 of the included studies received a fixed dose of fluoxetine 20 mg daily, while the second study utilized flexible fluoxetine doses up to 60 mg daily. Mixed effects longitudinal models determined whether the possible randomization to placebo at 12 weeks resulted in significant depressive symptom worsening across treatments. Correlations were computed between early symptom change (weeks 1-3 of open treatment) and postrandomization symptom change (weeks 13-16 following randomization).

resultsParticipants continuing to receive fluoxetine and those switched to placebo had significantly higher mean Hamilton Depression Rating Scale (HDRS) scores immediately postrandomization compared to the final weeks of open treatment (P < .001 for both fluoxetine- and placebo-treated patients). In both studies, early HDRS change was significantly correlated with postrandomization HDRS change for patients receiving fluoxetine (r = -0.46, P < .001) as well as placebo (r = -0.48, P < .001).

conclusionsThe possibility of receiving placebo following 12 weeks of open fluoxetine was associated with significant symptom worsening in 2 large fluoxetine discontinuation studies. Worsening depression scores following randomization were significantly associated with the degree of improvement participants experienced during weeks 1-3 of open treatment. These results suggest that treatment changes influence patients' expectations of improvement, which, in turn, affect their depressive symptoms.

Indexed as

Placebo EffectTreatment OutcomeAdultAntidepressive Agents, Second-GenerationDrug Administration ScheduleFemaleFluoxetineHumansMajor Depressive DisorderMaleMiddle AgedNocebo EffectPatientsPlacebosRandomized Controlled Trials as TopicTime FactorsAntidepressive Agents, Second-GenerationFluoxetinePlacebos

Identifiers

PMID25006812
PMCPMC4221413

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Registered trials

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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.