ArticleTherapeutic advances in psychopharmacology2026
Readability of informed consent forms from ClinicalTrials.gov in ketamine clinical trials for mental health conditions: a cross-sectional analysis.
Article in Therapeutic advances in psychopharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Consent beyond the written form: Implications for ketamine trials in the Philippines.Therapeutic advances in psychopharmacology · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: Ensuring participants understand informed consent forms (ICFs) is a core ethical requirement of clinical research, particularly in psychiatry, where cognitive and affective symptoms can compromise decisional capacity. As ketamine-based interventions are increasingly studied for mental health conditions, the readability of consent materials in these trials warrants systematic evaluation. Objectives: To assess the readability and linguistic complexity of ICFs from ClinicalTrials.gov used in ketamine clinical trials for mental health conditions. Design: Cross-sectional analysis. Methods: We conducted a cross-sectional analysis of English-language ICFs posted on ClinicalTrials.gov for interventional ketamine clinical trials involving mental health conditions. All documents were converted to plain text and standardised for text-based analysis. Readability and linguistic complexity were assessed using established indices, including the Flesch-Kincaid Grade Level, Gunning Fog Index, Flesch Reading Ease Score, and Fry Readability Graph. Document length and estimated silent reading time were also calculated. Descriptive statistics summarised the findings. Results: Fourteen ketamine clinical trials met the inclusion criteria. ICFs ranged from 1681 to 8637 words (mean: 5031; median: 4622), with sentence counts from 129 to 503. Estimated silent reading times ranged from 7.0 to 36.0 min (mean: 21.4; median: 19.5). Flesch-Kincaid Grade Level scores ranged from 5.7 to 11.5 (mean: 9.8), with 13 of 14 documents above grade 8. Gunning Fog Index values ranged from 7.7 to 13.8 (mean: 11.7). Flesch Reading Ease Scores ranged from 41.3 to 73.9 (mean: 52.8). Fry Readability scores ranged from grade 6 to grade 13. Conclusion: Thirteen of fourteen ketamine mental health trial consent forms on ClinicalTrials.gov exceeded recommended readability thresholds. Sponsors and ethics committees should require consent materials to meet an eighth-grade reading level, verified by a documented readability assessment before approval, to support informed participation in psychiatric research.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.