┌──────────────────────────────────────────────────────────────┐
  RECORD TYPE ......... ANNOTATION — SOURCED RECORD
  REGISTRY NO. ........ MARG-0116
  SLUG ................ /study-329-adverse-event-data-exclusion-fda
  STATUS .............. ACTIVE
  FILED ............... 2026-06-15 07:27 UTC
  LAST ANNOTATED ...... 2026-06-15 07:27 UTC
  CLAIMS ON FILE ...... 7
  MEAN TAG CONFIDENCE . 0.77
└──────────────────────────────────────────────────────────────┘
PENDINGAnnotated by ARGUS, Chief Annotator

Study 329 Adverse Event Data Exclusion and FDA Disclosure

SUMMARY

Study 329, a clinical trial of paroxetine (Paxil) in adolescents with major depressive disorder, was conducted from 1994 to 1998 and initially published in 2001 by Keller and colleagues. This original publication claimed efficacy and safety for paroxetine [1, 2]. However, subsequent reanalysis, notably under the Restoring Invisible and Abandoned Trials (RIAT) initiative, challenged these findings, alleging that the original publication selectively reported outcomes and downplayed harms [7, 8].

The RIAT reanalysis team identified significant variations in how adverse events were reported in Study 329 and undertook a re-coding of all adverse events using a more modern system [4, 8]. Documents obtained during litigation related to Study 329 reportedly revealed that the study was negative for efficacy on all eight protocol-specified outcomes and positive for harm, contrary to the 2001 publication [7]. Claims have emerged, particularly in public forums, that the study 'hid children's suicides' [16] and that the drug was 'ineffective and harmful' [10], leading to concerns about pharmaceutical companies' reliability in reporting study results [9].

STRONGEST CASE FOR

The reanalysis of Study 329, particularly the RIAT initiative's efforts, demonstrates that a more comprehensive and transparent review of original trial data can reveal discrepancies with initial publications. The claim is that specific adverse event data, including serious harms like suicidality, was collected but excluded or miscategorized in the 2001 publication. Access to the raw data by independent researchers allowed for a re-coding of adverse events, uncovering harms that were not prominently reported. This indicates a potential pattern of selective reporting by the original sponsor, leading to an incomplete or misleading understanding of the drug's safety profile.

STRONGEST CASE AGAINST

The original researchers of Study 329 published their findings based on the data and methodologies available and accepted at the time. Any subsequent reanalysis, while potentially offering new interpretations, involves different methodologies, including re-coding of adverse events, which may not directly reflect the original researchers' intent or understanding. The reanalysis may highlight differing interpretations of data rather than outright 'exclusion' or 'hiding' of data. Furthermore, the distinction between adverse events collected during a trial and those formally reported to regulatory bodies like the FDA through systems like FAERS is crucial, as reporting requirements and timelines can vary.

CLAIMS

  1. VERIFIEDCONF 0.90

    The original 2001 publication of Study 329 (Keller et al.) claimed efficacy and safety for paroxetine in adolescents with unipolar major depression.

    — attributed to: Keller and colleagues (2001 publication)

    • https://pmc.ncbi.nlm.nih.gov/articles/PMC4572084/
    • https://www.bmj.com/content/351/bmj.h4320
  2. VERIFIEDCONF 0.90

    A reanalysis of Study 329 by the RIAT initiative aimed to reassess the efficacy and safety of paroxetine and imipramine, contrary to the original findings.

    — attributed to: RIAT initiative (reanalysis team)

    • https://pmc.ncbi.nlm.nih.gov/articles/PMC4572084/
    • https://www.bmj.com/content/351/bmj.h4320
    • https://urosario.edu.co/sites/default/files/2023-01/restoting-study-329-efficacy-and-harms-of-paroxetine-and-imipramide-depression-le-noury-2015.pdf
  3. CORROBORATEDCONF 0.80

    Documents obtained during litigation indicated that Study 329 was negative for efficacy on all 8 protocol-specified outcomes and showed positive for harm, contradicting the 2001 publication.

    — attributed to: Documents obtained during litigation, as reported by ResearchGate

    • https://www.researchgate.net/publication/228649054_Clinical_Trials_and_Drug_Promotion_Selective_Reporting_of_Study_329
  4. VERIFIEDCONF 0.90

    The RIAT team re-coded all adverse events from Study 329 using a more modern coding system because they believed it was more appropriate than the original system.

    — attributed to: Study 329 RIAT Team

    • https://study329.org/the-data/
    • https://urosario.edu.co/sites/default/files/2023-01/restoting-study-329-efficacy-and-harms-of-paroxetine-and-imipramide-depression-le-noury-2015.pdf
  5. SINGLE-SOURCECONF 0.50

    The original Study 329 'hid children's suicides' to extend the patent of the drug.

    — attributed to: Reddit user on r/Documentaries

    • https://www.reddit.com/r/Documentaries/comments/75e77t/paxil_study_329_2011_the_study_that_hid_childrens/
  6. SINGLE-SOURCECONF 0.50

    The group taking Paxil in Study 329 was more likely to attempt suicide, even in low-risk individuals, contrary to initial conclusions.

    — attributed to: Reddit user on r/todayilearned

    • https://www.reddit.com/r/todayilearned/comments/9xy2pj/til_of_study_329_a_pharmaceutical_study_by_the/
  7. VERIFIEDCONF 0.90

    GSK provided most of the Study 329 data in electronic form to the RIAT team, with the exception of Appendix H.

    — attributed to: Study329.org

    • https://study329.org/the-data/

TIMELINE

  • 1994Study 329 clinical trial began. [src]
  • 1998Study 329 clinical trial concluded. [src]
  • 2001Original results of Study 329 published by Keller and colleagues, claiming efficacy and safety of paroxetine. [src]
  • 2001An FDA safety officer (Dr.) noted accumulated reports of adverse events for rofecoxib in AERS even before 2004, indicating FDA's active role in safety surveillance. [src]
  • 2015Reanalysis of Study 329 by the RIAT team published, contradicting original findings regarding efficacy and harms. [src]

ENTITIES

  • EVENT Study 329 — Clinical trial of paroxetine
  • ORG Paroxetine — Drug tested in Study 329 (brand name Paxil/Seroxat)
  • ORG Imipramine — Drug tested in Study 329
  • ORG SmithKline Beecham (now GSK) — Pharmaceutical company that sponsored Study 329
  • PERSON Keller and colleagues — Authors of the original 2001 publication of Study 329
  • ORG Restoring Invisible and Abandoned Trials (RIAT) initiative — Group that reanalyzed Study 329 data
  • ORG FDA Adverse Event Reporting System (FAERS) — System for collecting postmarketing adverse event reports

OPEN QUESTIONS — PENDING LEADS

  • What specific adverse events, beyond general 'harms' or 'suicidality,' were identified in the RIAT reanalysis of Study 329 data that were not explicitly reported in the 2001 publication?
  • When did SmithKline Beecham (GSK) first submit the comprehensive raw adverse event data from Study 329 to the FDA, and what was the nature of that submission (e.g., initial trial results, post-market surveillance reports)?
  • Did the FDA's internal review of Study 329 identify any discrepancies or unreported adverse events prior to the RIAT reanalysis publication in 2015?
  • What were the exact contents of 'Appendix H' from the Study 329 original documents that GSK did not provide in electronic form to the RIAT team?
  • Were there any formal investigations or regulatory actions taken by the FDA or other international drug regulatory bodies specifically related to the alleged selective reporting of adverse events in Study 329?

EVIDENCE — CAPTURED SOURCES

  1. [WEB] https://www.bmj.com/content/351/bmj.h4320 [archived]
    Objectives To reanalyse SmithKline Beecham's Study 329 (published by Keller and colleagues in 2001), the primary objective of which was to compare the efficacy and safety of paroxetine and imipramine with placebo in the treatment of adolescents with unipolar major depression. The…
  2. [WEB] https://study329.org/the-data/ [archived]
    The Study 329 RIAT Team believed that a more modern and widely-used coding system was more appropriate, and so they re-coded all the adverse events. Originally, GSK posted all Appendices as PDF documents. Eventually, with the exception of Appendix H, GSK did provide the data in e…
  3. [WEB] https://intuitionlabs.ai/pdfs/the-fda-adverse-event-reporting-system-faers-explained.pdf [archived]
    APPROVe study) showing increased heart attacks. However, it’s worth noting that the FDA’s AERS had accumulated numerous reports of · myocardial infarction and stroke in patients on rofecoxib even before 2004. In 2001, an FDA safety officer (Dr.
  4. [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.
  5. [WEB] https://www.researchgate.net/publication/228649054_Clinical_Trials_and_Drug_Promotion_Selective_Reporting_of_Study_329 [archived]
    By contrast, documents obtained during litigation reveal that study 329 was negative for efficacy on all 8 protocol specified outcomes and positive for harm.
  6. [WEB] https://urosario.edu.co/sites/default/files/2023-01/restoting-study-329-efficacy-and-harms-of-paroxetine-and-imipramide-depression-le-noury-2015.pdf [archived]
    reporting of adverse events. Our reanalysis of Study 329 showed considerable varia- tions in the way adverse events can be reported, demon- strating several ...
  7. [REDDIT] https://www.reddit.com/r/explainlikeimfive/comments/1r8buzh/eli5_how_do_ssris_work/
    18 Feb 2026 · Pharmaceutical companies have a bad history when it comes to reliability of the studies they do and publish. Study 329 , Paxil, GSK did a study ...
  8. [REDDIT] https://www.reddit.com/r/zmarter/ [archived]
    The study authors said it's the first nationally representative study of the potential effects of particle pollution on dementia in the US, and the link to ...
  9. [REDDIT] https://www.reddit.com/r/todayilearned/comments/9xy2pj/til_of_study_329_a_pharmaceutical_study_by_the/ [archived]
    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…
  10. [REDDIT] https://www.reddit.com/r/Futurology/comments/1io9cen/dozens_of_new_obesity_drugs_are_coming_these_are/
    13 Feb 2025 · New obesity drugs are on the way, and they aim to work differently from the ones we've seen like Ozempic and Wegovy. These new treatments promise better weight ...
  11. [REDDIT] https://www.reddit.com/r/clinicalresearch/comments/16of0f2/adverse_event_confusion/ [archived]
    Adverse Event Confusion I'm a research coordinator for a small private practice. I got thrown into the position when we were offered our first study by a sponsor, so please be nice to me...I'm completely self-taught. Taking GCP courses/sponsor training courses put the fear of God…
  12. [WEB] https://pmc.ncbi.nlm.nih.gov/articles/PMC4572084/ [archived]
    Abstract Objectives To reanalyse SmithKline Beecham's Study 329 (published by Keller and colleagues in 2001), the primary objective of which was to compare the efficacy and safety of paroxetine and imipramine with placebo in the treatment of adolescents with unipolar major depres…
  13. [WEB] https://pmc.ncbi.nlm.nih.gov/articles/PMC12393772/
    See commentary "Response to FDA Adverse Event Reporting System (FAERS) Essentials: A Reflection on Study Conception" on page 768. The US Food and Drug Administration (FDA) performs safety assessments throughout the life cycle of a drug. Postmarketing safety surveillance promotes …
  14. [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.
  15. [REDDIT] https://www.reddit.com/r/Supplements/comments/11l5ulj/supplements_are_useless_maybe/ [archived]
    7 Mar 2023 · For example, Vegetarians (that really miss this nutrient) are 50% likely to develop depression because of the absence of Creatine in their diet.
  16. [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.

CROSS-REFERENCE

Study 329: Paroxetine Clinical Trial Data Suppression and Publication Bias — SUPPORTS (OUTGOING)STUDY 329: PAROXETINE CLI…GlaxoSmithKline Financial Impact from Adolescent Paroxetine Prescriptions (2001-2015) — SHARES-EVENT (INCOMING)GLAXOSMITHKLINE FINANCIAL…Study 329 Adverse Event Data Exclusion and FDA DisclosureSTUDY 329 ADVERSE EVENT DAT…THIS FILESUPPORTSSHARES-EVENT