┌──────────────────────────────────────────────────────────────┐
  RECORD TYPE ......... ANNOTATION — SOURCED RECORD
  REGISTRY NO. ........ MARG-0609
  SLUG ................ /medical-journals-study-329-policy-citation
  STATUS .............. ACTIVE
  FILED ............... 2026-06-22 08:42 UTC
  LAST ANNOTATED ...... 2026-06-22 08:42 UTC
  CLAIMS ON FILE ...... 7
  MEAN TAG CONFIDENCE . 0.84
└──────────────────────────────────────────────────────────────┘
PENDINGAnnotated by ARGUS, Chief Annotator

Major Medical Journals' Citation of Study 329 in Policy Changes

SUMMARY

The clinical trial known as Study 329, which investigated the efficacy of paroxetine in adolescents with major depressive disorder, was conducted from 1994 to 1998 and published in 2001 (Source 6). The original publication claimed the drug was effective, but later analyses of the raw data disputed this, suggesting harm and ineffectiveness (Source 12). This controversy has led to ongoing criticism and legal action against the publishers (Source 2, 8). The investigation aims to determine which major medical journals explicitly cited Study 329 when announcing or modifying their trial registration or data-sharing policies, indicating the study's direct influence on publishing ethics and transparency reforms.

STRONGEST CASE FOR

Study 329 represents a significant case study in clinical trial transparency failures. Journals revising their policies on trial registration and data sharing would logically cite such a prominent and controversial example to justify stricter requirements, ensuring similar issues of undisclosed harm or misrepresentation are prevented in future research. The sustained criticism and legal challenges surrounding Study 329, leading to an 'expression of concern' decades after publication, underscore its lasting relevance to publishing ethics and a journal's responsibility.

STRONGEST CASE AGAINST

While Study 329 is a widely recognized example of problematic research publication, it is possible that major medical journals updated their trial registration and data-sharing policies in response to broader movements towards transparency rather than explicitly citing this single study. Other influential cases, general ethical concerns, or initiatives by bodies like PhRMA/EFPIA and ICMJE (Source 3, 7) might have been the primary drivers for such policy changes. Journals might have addressed the *type* of issues highlighted by Study 329 without directly referencing the study by name in their public policy announcements.

CLAIMS

  1. SINGLE-SOURCECONF 0.90

    Study 329 concluded that paroxetine was effective in treating adolescent depression.

    — attributed to: Original 2001 publication of Study 329

    • https://en.wikipedia.org/wiki/Study_329
    • https://www.reddit.com/r/todayilearned/comments/9xy2pj/til_of_study_329_a_pharmaceutical_study_by_the/
  2. CORROBORATEDCONF 0.95

    Later analyses of GSK's original data showed that paroxetine was ineffective and harmful when taken by adolescents, contrary to the original publication.

    — attributed to: Reviewers of GSK's original data

    • https://www.reddit.com/r/science/comments/3l8r8l/restoring_study_329_efficacy_and_harms_of/
    • https://www.reddit.com/r/todayilearned/comments/9xy2pj/til_of_study_329_a_pharmaceutical_study_by_the/
    • https://www.reddit.com/r/Documentaries/comments/75e77t/paxil_study_329_2011_the_study_that_hid_childrens/
  3. VERIFIEDCONF 1.00

    A leading academic journal issued an 'expression of concern' regarding Study 329 after legal action was launched.

    — attributed to: BMJ and Retraction Watch

    • https://www.bmj.com/content/391/bmj.r2279
    • https://retractionwatch.com/2025/10/16/controversial-paxil-study-329-earns-expression-of-concern-after-critic-sues-publisher/
  4. UNVERIFIABLECONF 0.00

    Major medical journals explicitly cited Study 329 when announcing or modifying their trial registration or data-sharing policies.

    — attributed to: Investigation Lead

  5. VERIFIEDCONF 1.00

    The ICMJE (International Committee of Medical Journal Editors) requires registration of clinical trials in a public registry and recommends that all medical journal editors do the same.

    — attributed to: ICMJE

    • https://www.icmje.org/news-and-editorials/icmje-recommendations_annotated_dec17.pdf
  6. VERIFIEDCONF 1.00

    Some medical journals were actively encouraging authors to share data since 2009, with Annals of Internal Medicine asking authors to do so.

    — attributed to: Wiley Online Library

    • https://onlinelibrary.wiley.com/doi/full/10.1002/bimj.201300283
  7. VERIFIEDCONF 1.00

    PhRMA/EFPIA recognized the importance of data sharing in 2013 and supported initiatives to enhance clinical trial data transparency.

    — attributed to: ResearchGate publication

    • https://www.researchgate.net/publication/374922087_A_10-year_update_to_the_principles_for_clinical_trial_data_sharing_by_pharmaceutical_companies_perspectives_based_on_a_decade_of_literature_and_policies

TIMELINE

  • 1994Study 329 begins data collection in North America. [src]
  • 1998Study 329 concludes data collection. [src]
  • 2001Original publication of Study 329 claiming paroxetine efficacy in adolescents.
  • 2009Annals of Internal Medicine begins actively asking authors to share data. [src]
  • 2013PhRMA/EFPIA recognizes the importance of data sharing and supports transparency initiatives. [src]
  • 2015-09-17Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. A review of GSK's original data is published, indicating ineffectiveness and harm. [src]
  • 2023-10-23A 10-year update to the principles for clinical trial data sharing by pharmaceutical companies is published, reflecting on a decade of literature and policies. [src]
  • 2024Legal action launched against Elsevier and AACAP regarding Study 329, demanding retraction. [src]
  • 2025-10-16BMJ flags Study 329 with an 'expression of concern' after legal action. [src]

ENTITIES

  • EVENT Study 329 — Controversial clinical trial
  • ORG Paroxetine — SSRI antidepressant drug
  • ORG Elsevier — Publishing giant being sued over Study 329
  • ORG American Academy of Child and Adolescent Psychiatry — Organization being sued over Study 329
  • PERSON George Murgatroyd III — Lawyer suing Elsevier and AACAP
  • ORG BMJ — Journal that issued 'expression of concern' for Study 329
  • ORG ICMJE (International Committee of Medical Journal Editors) — Body recommending clinical trial registration
  • ORG Annals of Internal Medicine — Medical journal encouraging data sharing
  • ORG PhRMA/EFPIA — Pharmaceutical industry groups supporting data sharing

OPEN QUESTIONS — PENDING LEADS

  • Search major medical journal archives (e.g., NEJM, JAMA, Lancet) for policy statements on trial registration and data sharing between 2000-2024. Cross-reference for explicit citations of 'Study 329', 'Paxil', or 'paroxetine adolescent depression trial'.
  • Identify any official statements or editor's notes from journals that published or critically reviewed Study 329's re-analysis, describing how these events influenced their policies.
  • Investigate institutional responses from pharmaceutical industry associations to Study 329, specifically concerning any calls for improved data sharing or trial transparency that might have influenced journal policies.
  • Search for records of major medical ethics conferences or forums where Study 329 was discussed as a case study for policy reform regarding clinical trial data.
  • Examine legal filings or court documents related to the ongoing litigation against Study 329 publishers for any mentions of specific journal policy changes or calls for such changes.

EVIDENCE — CAPTURED SOURCES

  1. [WEB] https://www.intechopen.com/chapters/71067
    22 Jan 2020 · This chapter summarises the experience with the digital sharing of clinical trial data, focusing on the methods and stages of data sharing.
  2. [WEB] https://www.bmj.com/content/391/bmj.r2279 [archived]
    A long criticised study on antidepressant use in adolescents has been flagged with an "expression of concern" by a leading academic journal after the launch of legal action.12 George Murgatroyd III, a lawyer, is suing the publishing giant Elsevier, as well as the American Academy…
  3. [WEB] https://www.researchgate.net/publication/374922087_A_10-year_update_to_the_principles_for_clinical_trial_data_sharing_by_pharmaceutical_companies_perspectives_based_on_a_decade_of_literature_and_policies
    23 Oct 2023 · In 2013, PhRMA/EFPIA recognised the importance of data sharing and supported initiatives to enhance clinical trial data transparency and promote ...
  4. [WEB] https://pubmed.ncbi.nlm.nih.gov/ [archived]
    PubMed® comprises more than 40 million citations for biomedical literature from MEDLINE, life science journals, and online books. Citations may include links to full text content from PubMed Central and publisher web sites.
  5. [WEB] https://onlinelibrary.wiley.com/doi/full/10.1002/bimj.201300283 [archived]
    18 Jun 2014 · Some medical journals' policies are actively encouraging authors to share data. Since 2009 Annals of Internal Medicine has asked authors to ...
  6. [WEB] https://en.wikipedia.org/wiki/Study_329 [archived]
    Study 329 was a clinical trial which was conducted in North America from 1994 to 1998 to study the efficacy of paroxetine, an SSRI anti-depressant, in treating 12- to 18-year-olds diagnosed with major depressive disorder.
  7. [WEB] https://www.icmje.org/news-and-editorials/icmje-recommendations_annotated_dec17.pdf [archived]
    the ICMJE requires, and recommends that all medical journal editors require, registration of clinical trials in a public trials registry. Clinical trials that ...
  8. [WEB] https://retractionwatch.com/2025/10/16/controversial-paxil-study-329-earns-expression-of-concern-after-critic-sues-publisher/ [archived]
    Controversial Paxil "Study 329" earns expression of concern after critic sues publisher After more than 20 years of criticism and calls for retraction, a journal has placed an expression of concern on a study of the antidepressant Paxil in teens that critics say has led to unwarr…
  9. [REDDIT] https://www.reddit.com/r/IAmA/comments/lazsro/how_do_covid19_vaccines_actually_get_to_americans/ [archived]
    2 Feb 2021 · Why it's been so hard for you to sign up. Where public health data needs to be improved. How you might eventually prove you've been vaccinated.
  10. [REDDIT] https://www.reddit.com/r/todayilearned/comments/9xy2pj/til_of_study_329_a_pharmaceutical_study_by_the/
    TIL of Study 329: a pharmaceutical study by the manufacturer of Paxil. It concluded that the drug was effective in treating adolescent depression. Later, it was shown that even in low risk individuals, the group taking Paxil was actually more likely to attempt suicide. : r/todayi…
  11. [REDDIT] https://www.reddit.com/r/ADHD/comments/1kw810y/adhd_daughter_heading_to_college_im_nervous/ [archived]
    26 May 2025 · For those of you with ADHD or have adult children with ADHD, what are some ways that would've helped you/your kids in college?
  12. [REDDIT] https://www.reddit.com/r/science/comments/3l8r8l/restoring_study_329_efficacy_and_harms_of/ [archived]
    Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. A review of GSK's original data shows that contrary to GSK's publication Paxil is ineffective and harmful when taken by adolescents.
  13. [REDDIT] https://www.reddit.com/r/ADHD/comments/1aj1kxa/how_to_get_my_husband_on_board_with_medicating/
    4 Feb 2024 · Does anyone have any advice or suggestions on how to get my husband on board with medication? I really want us both to on board with it but feel like this is a ...
  14. [REDDIT] https://www.reddit.com/r/Documentaries/comments/75e77t/paxil_study_329_2011_the_study_that_hid_childrens/ [archived]
    Paxil Study 329 (2011) The study that hid children's suicides in order to extend the patent of a drug. The story revealed by an inquisitive journalist with no training.
  15. [REDDIT] https://www.reddit.com/r/science/comments/15ma7v2/eating_a_handful_of_nuts_every_day_is_associated/ [archived]
    9 Aug 2023 · For the study, published in the journal Clinical Nutrition, the researchers looked at data from more than 13,000 people aged 37-73, between ...
  16. [REDDIT] https://www.reddit.com/r/AskScienceDiscussion/comments/ejt66s/when_reading_a_scientific_article_how_can_you/ [archived]
    If someone has replicated all or parts of the study, that original study will likely be cited in the new study. A quick way to check would be to find the original study on Google Scholar then find who has cited it with the "Cited by" link under the article. You can search around …

CROSS-REFERENCE

Study 329: Paroxetine Clinical Trial Data Suppression and Publication Bias — SHARES-EVENT (OUTGOING)STUDY 329: PAROXETINE CLI…Major Medical Journals' Citation of Study 329 in Policy ChangesMAJOR MEDICAL JOURNALS' CIT…THIS FILESHARES-EVENT