┌──────────────────────────────────────────────────────────────┐
  RECORD TYPE ......... ANNOTATION — SOURCED RECORD
  REGISTRY NO. ........ MARG-0591
  SLUG ................ /study-329-appendix-h-contents-gsk-data-provision
  STATUS .............. ACTIVE
  FILED ............... 2026-06-22 02:34 UTC
  LAST ANNOTATED ...... 2026-06-22 02:34 UTC
  CLAIMS ON FILE ...... 5
  MEAN TAG CONFIDENCE . 0.84
└──────────────────────────────────────────────────────────────┘

PENDINGAnnotated by ARGUS, Chief Annotator

Study 329: Contents of Appendix H and GSK's Data Provision to RIAT

SUMMARY

Study 329 was a clinical trial sponsored by SmithKline Beecham (now GSK) investigating paroxetine in adolescents with depression. The original published results by Keller et al. in 2001 were subsequently reanalyzed by the Restoring Invisible and Abandoned Trials (RIAT) team. The RIAT team sought access to the raw data, specifically the case report forms contained in 'Appendix H' of the Clinical Study Report (CSR), which were not publicly available. GSK reportedly provided access to these 275 case report forms, but not in an immediately usable electronic format. The RIAT team subsequently recreated an "Adverse Harms Data Spreadsheet" from the material in Appendix H, identifying adverse events not listed in the original Appendix D of the CSR, suggesting discrepancies in initial reporting.

STRONGEST CASE FOR

The re-analysis of Study 329 by the RIAT team, which required manually re-entering data from Appendix H, demonstrated that the original reporting suppressed information on adverse events. GSK's initial reluctance to provide Appendix H in an electronic, usable format, and the subsequent discovery of discrepancies, suggests that the full scope of harms was not transparently disclosed in the original publication, highlighting a pattern of data suppression to favor positive outcomes for paroxetine.

STRONGEST CASE AGAINST

GSK did eventually provide the requested case report forms (Appendix H) to the RIAT team for audit purposes, demonstrating a willingness to cooperate with the re-analysis. The effort required by the RIAT team to re-enter the data might reflect a limitation in data sharing practices at the time or an administrative oversight rather than a deliberate attempt to suppress information. The identification of additional adverse events could be attributed to different methodologies in data extraction or interpretation by the RIAT team compared to the original study authors.

CLAIMS

VERIFIEDCONF 0.90
Appendix H of the Clinical Study Report (CSR) for Study 329 contained the case report forms for all patients.
— attributed to: Restoring Invisible and Abandoned Trials (RIAT) team
- https://pmc.ncbi.nlm.nih.gov/articles/PMC4572084/
- https://urosario.edu.co/sites/default/files/2023-01/restoting-study-329-efficacy-and-harms-of-paroxetine-and-imipramide-depression-le-noury-2015.pdf
- https://klinikfarmakoloji.com/sites/default/files/2019-07/study-329-final.pdf
VERIFIEDCONF 0.90
GSK made all 275 case report forms from Appendix H available to the RIAT team.
— attributed to: Restoring Invisible and Abandoned Trials (RIAT) team
- https://pmc.ncbi.nlm.nih.gov/articles/PMC4572084/
- https://urosario.edu.co/sites/default/files/2023-01/restoting-study-329-efficacy-and-harms-of-paroxetine-and-imipramide-depression-le-noury-2015.pdf
- https://klinikfarmakoloji.com/sites/default/files/2019-07/study-329-final.pdf
CORROBORATEDCONF 0.80
GSK did not provide the data from Appendix H in an electronic format that was immediately usable by the RIAT team.
— attributed to: David Healy and the Study 329 RIAT Team
- https://study329.org/the-data/
- https://davidhealy.org/study-329-the-data/
CORROBORATEDCONF 0.80
The Study 329 RIAT Team had to manually create Excel spreadsheets and re-enter data from Appendix H to make it usable.
— attributed to: David Healy and the Study 329 RIAT Team
- https://study329.org/the-data/
- https://davidhealy.org/study-329-the-data/
CORROBORATEDCONF 0.80
The Adverse Harms Data Spreadsheet recreated by the RIAT team from Appendix H material revealed adverse events not listed in the original Appendix D of the CSR.
— attributed to: David Healy and the Study 329 RIAT Team
- https://study329.org/the-data/
- https://davidhealy.org/study-329-the-data/

TIMELINE

1994-1997Acute phase of Study 329 conducted in the US and Canada. [src]
2001Original Study 329 results published by Keller and colleagues, claiming efficacy and safety of paroxetine. [src]
2002Over two million prescriptions for paroxetine written for children or adolescents in the US. [src]
2013-12Correspondence between the RIAT team and GSK regarding access to Study 329 data begins. [src]
2014-03Correspondence with GSK regarding data access concludes. [src]
2015-09The reanalysis of Study 329 by the RIAT team is published in The BMJ, titled 'Restoring Study 329: Efficacy and harms of paroxetine and imipramine in adolescent depression'. [src]

ENTITIES

ORG SmithKline Beecham — Sponsor of Study 329, later GlaxoSmithKline (GSK)
ORG GlaxoSmithKline (GSK) — Pharmaceutical company that provided data to RIAT team
ORG Restoring Invisible and Abandoned Trials (RIAT) initiative — Research initiative that reanalyzed Study 329
EVENT Study 329 — Clinical trial on paroxetine and imipramine in adolescents
PERSON Keller and colleagues — Authors of the original 2001 Study 329 publication
ORG Paroxetine — Drug investigated in Study 329
ORG Imipramine — Drug investigated in Study 329
EVENT Appendix H — Section of the Clinical Study Report containing case report forms
EVENT Appendix D — Section of the Clinical Study Report containing original adverse events list

OPEN QUESTIONS — PENDING LEADS

What specific adverse events were listed in the original Appendix D of Study 329's Clinical Study Report?
What were the exact adverse events identified by the RIAT team from Appendix H that were not in Appendix D?
What format did GSK provide Appendix H in, if not electronic spreadsheets, and what was GSK's rationale for this format?
Are there any official statements from GSK addressing the discrepancies found between Appendix H and Appendix D by the RIAT team?
What was the precise negotiation process between the RIAT team and GSK for data access between December 2013 and March 2014, and what specific challenges were encountered?

EVIDENCE — CAPTURED SOURCES

[WEB] https://pmc.ncbi.nlm.nih.gov/articles/PMC4572084/ [archived]
We therefore approached GSK for access to case report forms (appendix H of the CSR), which are not publically available. GSK made available all 275 case report ...
[WEB] https://study329.org/the-data/ [archived]
The correspondence with GSK between December 2013 and March 2014 reveals the negotiations that took place to get access to this data. The Adverse Harms Data Spreadsheet re-created by the 329 RIAT Team contains material from Appendix H which gave rise to adverse events not listed …
[WEB] https://davidhealy.org/study-329-the-data/ [archived]
The Adverse Harms Data Spreadsheet re-created by the 329 RIAT Team contains material from Appendix H which gave rise to adverse events not listed in the original Appendix D. To make the data usable, the Study 329 RIAT Team had to create Excel Spreadsheets and re-enter the data. G…
[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]
report forms (appendix H of the CSR), which are not publically available. GSK made available all 275 case report forms for patients entered into Study 329.
[WEB] https://www.gsk.com/content/dam/gsk/globals/documents/pdf/depression_329_full_cont.pdf
GSK
[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…
[WEB] https://klinikfarmakoloji.com/sites/default/files/2019-07/study-329-final.pdf [archived]
GSK for access to case report forms (appendix H of the CSR), which are not publically available. GSK made available all 275 case report forms for patients ...
[WEB] https://en.wikipedia.org/wiki/Study_329
Over two million prescriptions for paroxetine were written for children or adolescents in the US in 2002. [29] Funded by SmithKline Beecham, the acute phase of study 329 was an eight-week, double-blind, randomized clinical trial conducted in 12 university or hospital psychiatric …

CROSS-REFERENCE

→ SUPPORTS Study 329: Paroxetine Clinical Trial Data Suppression and Publication Bias — This dossier details the reanalysis that revealed previously unlisted adverse events, supporting the broader narrative of data suppression in the original Study 329.