The Ethics of Clinical Trials Research in Severe Mood Disorders
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 iss...
| Auteur principal: | |
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| Collaborateurs: | ; ; |
| Type de support: | Électronique Article |
| Langue: | Anglais |
| Vérifier la disponibilité: | HBZ Gateway |
| Journals Online & Print: | |
| Interlibrary Loan: | Interlibrary Loan for the Fachinformationsdienste (Specialized Information Services in Germany) |
| Publié: |
[2017]
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| Dans: |
Bioethics
Année: 2017, Volume: 31, Numéro: 6, Pages: 443-453 |
| RelBib Classification: | KBQ Amérique du Nord NCH Éthique médicale NCJ Science et éthique ZD Psychologie |
| Sujets non-standardisés: | B
Dépression
B mood disorders B Bipolar disorder B Research B Clinical Trials B Psychiatry |
| Accès en ligne: |
Accès probablement gratuit Volltext (Verlag) Volltext (doi) |
| Résumé: | 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. |
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| ISSN: | 1467-8519 |
| Contient: | Enthalten in: Bioethics
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| Persistent identifiers: | DOI: 10.1111/bioe.12349 |