Trial reportPsychopharmacology2021
Safety and tolerability of chronic intranasal oxytocin in older men: results from a randomized controlled trial.
Trial report in Psychopharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
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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
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.
- Oxytocin in old age psychiatry: A systematic review of the safety of using intranasal oxytocin in older adults.Australasian psychiatry : bulletin of Royal Australian and New Zealand College of Psychiatrists · 2025Pooled it
- Effects of four-week intranasal oxytocin administration on large-scale brain networks in older adults.Neuropharmacology · 2024Trial
- Effects of chronic intranasal oxytocin on visual attention to faces vs. natural scenes in older adults.Psychoneuroendocrinology · 2024Trial
- Four-week intranasal oxytocin administration reduces attachment avoidance in older women.Hormones and behavior · 2023Trial
- Oxytocin as regulator of stress and inflammation in aging.Neuroscience and biobehavioral reviews · 2026Review
- Cytosolic Peptide: N-Glycanase (NGLY1)-from Basic Biology to Genetic Disorder, NGLY1 Deficiency.Advances in experimental medicine and biology · 2026Review
- Unraveling the impact of oxytocin receptor gene methylation on stress and inflammation in older adults.Journal of neuroendocrinology · 2026Article
- Interplay of plasma Oxytocin and oxytocin receptor gene methylation levels on empathy in older adults.Scientific reports · 2025Article
- The Oxytocin System and Implications for Oxytocin Deficiency in Hypothalamic-Pituitary Disease.Endocrine reviews · 2025Review
- Oxytocin in neurodevelopmental disorders: Autism spectrum disorder and Prader-Willi syndrome.Pharmacology & therapeutics · 2024Review
- Intranasal oxytocin suppresses seizure-like behaviors in a mouse model of NGLY1 deficiency.Communications biology · 2024Article
- Oxytocin as a treatment for high-risk psychosis or early stages of psychosis: a mini review.Frontiers in psychiatry · 2023Review
- Evaluating the neuropeptide-social cognition link in ageing: the mediating role of basic cognitive skills.Philosophical transactions of the Royal Society of London. Series B, Biological sciences · 2022Article
- Chronic oxytocin administration in older men modulates functional connectivity during animacy perception.Aging brain · 2021Article
- Review
Corrections and comments
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Authors and funding
13 authors at 2 institutions in 1 country.
Funding
Abstract
rationaleMost studies evaluating the safety and tolerability of intranasal oxytocin (OT) have not reported consistent adverse events (AEs), but they have largely focused on young men and single-dose administration. Thus, it is unclear whether these findings translate to older individuals and with longer administration periods.
objectiveExtending previous work, this study investigated the safety and tolerability of chronic intranasal OT in generally healthy older men.
methodsData were from a randomized, placebo (P)-controlled, double-blind clinical trial evaluating the effects of 4 weeks of self-administered intranasal OT (24 IU twice daily) in older adults with no major physical or cognitive impairments. Heart rate, blood pressure, urine osmolality, and serum metabolic biomarkers were obtained before and at the end of the intervention. AEs were collected during the first 3 weeks and 1 week after cessation of treatment.
resultsOf 103 participants recruited, 95 were randomized and received the intervention (OT = 49, P = 46). OT had no significant impact on cardiovascular, urine, or serum measures. The AEs reported for both treatments were generally mild and few in number, though one participant assigned to OT and two assigned to P dropped out due to AEs. Relative to P, OT did not significantly increase the likelihood of reporting AEs, nor the number or severity of AEs reported.
conclusionChronic intranasal OT appears safe and well-tolerated in generally healthy older men. These findings provide support for continued human research on potential benefits of chronic OT in older adult populations.
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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.