Evidence map›Paper›PMID 28503892›Full record

ArticleBioethics2017

The Ethics of Clinical Trials Research in Severe Mood Disorders.

Allison C Nugent, Franklin G Miller, Ioline D Henter, Carlos A Zarate

Abstract read
In one paragraph

Article in Bioethics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–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

11 citing papers in PubMed.

  1. Article
  2. Off-label Prescribing of Clozapine and Safety.Turk psikiyatri dergisi = Turkish journal of psychiatry · 2025
    Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. Carers' Motivations for, and Experiences of, Participating in Suicide Research.International journal of environmental research and public health · 2020
    Article
  8. Article
  9. Article
  10. Expanding Access to Cancer Clinical Trials for Patients With Mental Illness.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
    Article
  11. Review
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.

Franklin G Miller
Ioline D Henter
Carlos A Zarate

Funding

Glutamatergic Modulators for Rapid & Sustained Antidepressant EffectZIAMH002857 · NIMH · NATIONAL INSTITUTE OF MENTAL HEALTH · PI ZARATE, CARLOS · 2009 to 2025
$55.0M
Target validation of novel therapeutic agents in mood disordersZIAMH002927 · NIMH · NATIONAL INSTITUTE OF MENTAL HEALTH · PI ZARATE, CARLOS · 2010 to 2025
$37.1M
Intramural NIH HHS Z99 MH999999Intramural NIH HHS ZIA MH002927
6 · The paper itself

Abstract

Mood disorders, including major depressive disorder (MDD) and bipolar disorder (BD), are highly prevalent, frequently disabling, and sometimes deadly. Additional research and more effective medications are desperately needed, but clinical trials research in mood disorders is fraught with ethical issues. Although many authors have discussed these issues, most do so from a theoretical viewpoint. This manuscript uses available empirical data to inform a discussion of the primary ethical issues raised in mood disorders research. These include issues of consent and decision-making capacity, including patients' motivations for participating in research. We also address drug withdrawals, placebo controls, and the overall safety of research. Finally, we examine the extant literature for studies discussing potential indirect benefits of clinical trials research to participants. Taken together, the evidence suggests that clinical trials research incorporating drug withdrawals and placebo controls can be conducted safely and ethically, even in patients with severe or treatment-resistant mood disorders. In fact, given the dearth of effective treatment options for this population, it is our opinion that a moral imperative exists to extend the offer of research participation to severely ill or treatment-resistant groups.

Indexed as

Biomedical ResearchBipolar DisorderClinical Trials as TopicDecision MakingHumansMajor Depressive DisorderMood DisordersTreatment Outcomebipolar disorderclinical trialsdepressionmood disorderspsychiatryresearch

Identifiers

PMID28503892
PMCPMC5469708

What OpenQuestion holds

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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.