┌──────────────────────────────────────────────────────────────┐ RECORD TYPE ......... SUBJECT FILE SUBJECT TYPE ........ EVENT FILE OPENED ......... 2026-07-05 17:23 UTC APPEARANCES ......... 26 ANNOTATIONS KNOWN ALIASES ....... 1 └──────────────────────────────────────────────────────────────┘
Study 329
ALSO APPEARS AS
- Study 329
APPEARS IN THE MARGINS OF
- GSK Contractual Restrictions on Paroxetine Research Publication
This investigation concerns whether GlaxoSmithKline (GSK) contractually restricted Martin Keller's ability to publish findings unfavorable to the antidepressant paroxetine (marketed as Paxil/Seroxat),…
- Paroxetine Prescriptions for Adolescents (2001-2015) After Study 329 Publication
Study 329 was a clinical trial of paroxetine and imipramine in adolescents with major depression, funded by SmithKline Beecham and published in 2001. The original publication by Keller and colleagues …
- Study 329 Ghostwriting: Prior Disclosure in Review Boards or Journals
Study 329 was a clinical trial of the antidepressant paroxetine (Paxil) for adolescents with major depressive disorder, conducted by SmithKline Beecham (later GlaxoSmithKline) from 1994 to 1998. The o…
- Study 329: Regulatory and Journal Policy Changes on Trial Registration and Data Sharing
The clinical trial Study 329, involving the antidepressant paroxetine, has been a focal point for discussions around data transparency and publication ethics. The trial's original 2001 publication cla…
- Study 329 Adverse Event Data Exclusion and FDA Disclosure
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…
- Study 329: Contents of Appendix H and GSK's Data Provision to RIAT
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 subsequen…
- Medical Guidance on Paroxetine for Adolescents and Study 329 Reference (2001-2015)
Following the 2001 publication of Study 329, an influential clinical trial on the antidepressant paroxetine (Paxil/Seroxat) for adolescent depression, questions arose regarding its efficacy and safety…
- Study 329: FDA and International Regulatory Investigations into Adverse Event Reporting
Study 329, a clinical trial for the antidepressant paroxetine (Paxil/Seroxat) in adolescents, has been the subject of allegations regarding selective reporting of adverse events. Concerns primarily ce…
- Paroxetine Prescription Rates for Adolescents (2001-2015)
This dossier investigates the annual prescription numbers for paroxetine to adolescents in the US and other major markets between 2001 and 2015. While a declassified FDA statement from March 2004 advi…
- Paroxetine Off-Label Adolescent Use Data Prior to 2015 Reanalysis
The question concerns the availability of publicly accessible sales volume or prescription data specifically for off-label paroxetine use in adolescents prior to the 2015 reanalysis of Study 329. Whil…
- Martin Keller's Role and Statements in Study 329 Paroxetine Trial
Study 329 was a clinical trial conducted from 1994 to 1998 to evaluate the efficacy of paroxetine (Paxil/Seroxat), an SSRI antidepressant, for major depressive disorder in adolescents aged 12-18 [2, 6…
- Study 329 RIAT Reanalysis: Previously Unreported Adverse Events
Study 329 was an industry-sponsored clinical trial of paroxetine (Paxil/Seroxat) for adolescent depression, originally published in 2001. The original publication claimed the drug was generally well-t…
- GSK Paroxetine Trials: Publication Rights and Ghostwriting Agreements
This dossier investigates the availability of contractual agreements between GlaxoSmithKline (GSK) and individual researchers, such as Martin Keller, involved in paroxetine clinical trials, particular…
- SmithKline Beecham Study 329 Adverse Event Data Submission to FDA
Study 329 was a clinical trial of paroxetine (Paxil) in adolescents with major depressive disorder, conducted by SmithKline Beecham (now GlaxoSmithKline - GSK). The original published report in 2001 p…
- FDA Internal Review of Study 329 Adverse Events Pre-RIAT
Study 329 was a clinical trial conducted by SmithKline Beecham (now GlaxoSmithKline) between 1994 and 1998, investigating the efficacy and safety of paroxetine and imipramine in adolescents with major…
- GlaxoSmithKline Financial Impact from Adolescent Paroxetine Prescriptions (2001-2015)
This dossier investigates the financial impact on GlaxoSmithKline (GSK) from adolescent paroxetine prescriptions between 2001 and 2015, following the publication of Study 329. Study 329, published in …
- Study 329's Impact on Adolescent Antidepressant Prescriptions
Study 329, a clinical trial evaluating paroxetine and imipramine for adolescent major depression, was originally published in 2001, claiming efficacy and safety for paroxetine [1]. This original publi…
- GlaxoSmithKline Study 329: Ghostwriting and Non-Disclosure Claims
Study 329 was a clinical trial of the antidepressant Paxil (paroxetine) conducted by SmithKline Beecham (now GlaxoSmithKline) between 1994 and 1998, comparing it to Tofranil and placebo in depressed c…
- Study 329: IRB Approval Process and Conflicts of Interest Review
This dossier investigates the Institutional Review Board (IRB) approval process for Study 329, a controversial clinical trial on paroxetine in adolescents. IRBs are committees federally required to re…
- Journal of the American Academy of Child and Adolescent Psychiatry Pre-2015 Ghostwriting Policies
This dossier investigates whether the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP), the original publisher of Study 329, had explicit editorial policies or communication…
- Study 329: Allegations of Ghostwriting in Paroxetine Clinical Trial
Study 329 was a clinical trial conducted by SmithKline Beecham (now GlaxoSmithKline or GSK) between 1994 and 1998 to evaluate the efficacy of paroxetine (Paxil) in adolescents with major depressive di…
- Major Medical Journals' Citation of Study 329 in Policy Changes
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). Th…
- ICMJE Data Sharing Recommendations and Study 329 Controversies
This dossier investigates whether official statements from the International Committee of Medical Journal Editors (ICMJE) or similar bodies explicitly link the controversies surrounding Study 329 to t…
- Pharmaceutical Industry Transparency Guidelines Post-Study 329 Scrutiny
Following significant scrutiny over the transparency of clinical trial data, particularly concerning GlaxoSmithKline's Study 329, pharmaceutical industry bodies have committed to enhanced data sharing…
- Medical Writing Support Disclosure Guidelines for IRBs and Journals (1994-2001)
This dossier investigates the guidelines concerning the disclosure of medical writing support by Institutional Review Boards (IRBs) and medical journals between 1994 and 2001, a period encompassing th…
- Study 329's Influence on FDA/EMA Data Sharing Policies
This dossier investigates whether Study 329, a controversial clinical trial on paroxetine in adolescents, directly influenced specific regulatory guidance or policy documents issued by the FDA or EMA …