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NCT05628467
Association Between Antidepressant Use and Falls in Older Adults: Analysis of the World Health Organization Global Database
trial testing Antidepressive Agents in Antidepressants Causing Adverse Effects in Therapeutic Use in 100,000 participants. Completed in 1 August 2022.
1 August 2022
Quick facts
| Lead sponsor | University Hospital, Caen |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 100,000 |
| Start date | 1 July 2022 |
| Primary completion | 1 August 2022 |
| Estimated completion | 1 August 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- Antidepressive Agents — full drug profile →
Conditions studied
- Antidepressants Causing Adverse Effects in Therapeutic Use — all drugs for Antidepressants Causing Adverse Effects in Therapeutic Use →
- Fall — all drugs for Fall →
Sponsor
University Hospital, Caen
Who can join
Adults 65 to 120, any sex, with Antidepressants Causing Adverse Effects in Therapeutic Use or Fall. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The incidence of fall in older adults aged 65 and over is estimated at 30%, and 50% of the people aged 80 and over with at least one fall a year. Falls are associated with significant morbidity and mortality. The origin falls is often multifactorial, involving intrinsic and extrinsic factors. Few studies have investigated the association with all antidepressants. Potential adverse effects of antidepressants such as hyponatremia, sedation, orthostatic hypotension, extrapyramidal symptoms are known risk factors for falls. Due to multimorbidity, polypharmacy including interaction risks, and aging-related changes in pharmacokinetic and pharmacodynamic of drugs, antidepressants may further increase this risk in older patients. Based on the World Health Organization global database, the main objective of this study is to investigate the association between antidepressants classes and the occurrence of falls reported in the database. A disproportionality analysis will be performed. It will aim to assess whether some classes of antidepressants, and within these classes some molecules, are associated with a greater risk of falls. A mediation analysis will also be performed. It will aim to examine some of the mediators involved in the association between antidepressants classes and falls.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Association between antidepressant drugs and falls in older adults: A mediation analysis in the World Health Organization's pharmacovigilance database.
Minoc EM, Villain C, Chrétien B, Benbrika S, et al · · 2025 · cited 1× · PMID 40037976 · DOI 10.1016/j.therap.2025.01.004
Verify or expand the search:
- PubMed search for NCT05628467
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05628467 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Caen
- Last refreshed: 28 November 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05628467.
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