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Transparency of results reporting for depression treatment studies in ClinicalTrials.gov: a cross-sectional study
  1. Karen B Schmaling1,
  2. Hailey S Landon1,
  3. Tiffany B Nguyen1,
  4. Robert M Kaplan2
  1. 1Psychology, Washington State University—Vancouver, Vancouver, Washington, USA
  2. 2Clinical Excellence Research Center, Stanford University, Stanford, California, USA
  1. Correspondence to Dr Karen B Schmaling, Psychology, Washington State University - Vancouver, Vancouver, WA 98686, USA; karen.schmaling{at}wsu.edu

Abstract

Objectives Depression affects an estimated 7% of the adult population at an estimated cost of over US$200 billion/year in the USA. Complete, transparent reporting of clinical trial data facilitates valid estimates of treatment efficacy. In the USA, ClinicalTrials.gov increases transparency through mandatory prospective trial registration and outcome reporting. We examined characteristics of the transparent reporting of depression treatment studies registered in ClinicalTrials.gov.

Design Cross sectional.

Setting and participants US-based studies identified in a search of ClinicalTrials.gov with depression as the condition, enrolling ages 18 and older, and completed between 1 January 2008 and 1 May 2019.

Interventions All interventions were included.

Main outcomes and measures The main outcome was whether any results were reported prior to 1 May 2020. Data were extracted regarding inclusion and exclusion criteria, publications related to the study and specification of hypotheses.

Results 725 studies involving 156 634 patients met inclusion criteria. 416 (57.4%) of the studies posted some results. However, statistical test results were not included in 230 studies (55.3%). Most studies had data that could have been analysed and reported. Compared with studies without results, studies with any results were more likely to have hypotheses, include drug treatment conditions, and to have publications related to the study.

Conclusions Required study registration does not always result in transparent outcome reporting. Better compliance with mandated reporting and improved reporting standards would facilitate a more comprehensive representation of depression treatment research.

  • mental disorders
  • evidence-based practice

Data availability statement

The analysis dataset is available upon reasonable request to the first author at karen.schmaling@wsu.edu.

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Data availability statement

The analysis dataset is available upon reasonable request to the first author at karen.schmaling@wsu.edu.

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Footnotes

  • Contributors KBS had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: KBS and RMK. Acquisition, analysis, or interpretation of data: all authors. Drafting of the manuscript: all authors. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: KBS.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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