NCT00459264: PRE-EMPT: folic acid for mood-disorder prevention

Medicine Signal Editorial Desk
Updated 2026-10-10

Registry status when checked 2026-10-10Completed

NCT00459264 is PRE-EMPT, a randomized folic-acid prevention trial in young people at familial risk of mood disorders. Participants aged 14–24 received folic acid 2.5 mg daily or placebo for up to 36 months; these were research doses, not a general supplementation recommendation. 1 2 3

The original publication obtained primary outcome data from 112 participants, 56 per group. Mood disorders developed in 14.3% of the folic-acid group versus 17.9% of the placebo group, a nonsignificant difference. Thus the trial did not demonstrate prevention of mood-disorder onset. 3

A post-hoc analysis suggested delayed onset among participants who became unwell, but that exploratory observation should not override the negative primary result. The modest sample and fewer-than-expected incident disorders limit precision. This identifier is resolved and has published findings; it is not an unidentified trial. 3

Sources

1. ClinicalTrials.gov — ClinicalTrials.gov — NCT00459264. Original study registration: sponsor, design, population, endpoints and dated history.Original study registration · Original record checked against the registry API. Checked 2026-10-10. Registration and current registry fields do not by themselves establish efficacy. Historical details in the article retain their stated date. Supplied note: ClinicalTrials.gov — NCT00459264. Original study registration: sponsor, design, population, endpoints and dated history.

2. ICH GCP — ICH GCP — readable reproduction of the sponsor-submitted ClinicalTrials.gov record. Supports the registration details quoted here; not an independent clinical-results publication.Cited supporting source · Link and description preserved from supplied research. Checked in supplied research dated 2026-10-10. Source description comes from supplied research; underlying page was not independently re-read for this update.

3. PubMed — Sharpley et al.: original randomized trial, 2014Research publication · Publication abstract read via Europe PMC; identifier and title cross-checked. Checked 2026-10-10. Full paper was not independently re-read for this update; abstract details should not be extended beyond what it reports.