FDA analysis of 372 trials: antidepressants raised suicidal behavior under 25 and lowered it at 65 and over
99,231 adults in placebo-controlled trials. Odds ratios for suicidal behavior on antidepressants: 2.30 under age 25, 0.87 at 25 to 64, 0.06 at 65 or older.
Well-supported by good-quality research. how we score evidence
Caveat on this rating: Short trials that were not designed to measure suicidality; events identified retrospectively from adverse event reports. Trials exclude the most acutely suicidal patients. Absolute event rates were low in every age group.
The risk people fear most when starting an antidepressant is the one on the boxed warning. This is the FDA's own analysis of the trials companies submitted.
Significant findings
Stone, Laughren and FDA colleagues (BMJ, 2009) pooled "372 double blind randomised placebo controlled trials" with "99 231 adults assigned to antidepressants or placebo."
"For participants with non-psychiatric indications, suicidal behaviour and ideation were extremely rare. For those with psychiatric indications, risk was associated with age. For suicidal behaviour or ideation and for suicidal behaviour only, the respective odds ratios were 1.62 (95% confidence interval 0.97 to 2.71) and 2.30 (1.04 to 5.09) for participants aged <25, 0.79 (0.64 to 0.98) and 0.87 (0.58 to 1.29) for those aged 25-64, and 0.37 (0.18 to 0.76) and 0.06 (0.01 to 0.58) for those aged >or=65."
"Risk of suicidality associated with use of antidepressants is strongly age dependent. Compared with placebo, the increased risk for suicidality and suicidal behaviour among adults under 25 approaches that seen in children and adolescents."
Worth asking
These are randomized trials, so this is not confounding: in people under 25 the drug, not the illness, accounts for the difference. The events were rare in absolute terms, and the trials were short. For adults in midlife the effect was neutral, and for older adults it was strongly protective. One sentence does not fit all ages. The first weeks after starting or changing a dose are when to watch most closely, and someone close to you should know that too. If you are in crisis in the US, call or text 988. Never stop an antidepressant on your own.
Source
Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration — Stone M, Laughren T, Jones ML, Levenson M, Holland PC, Hughes A, Hammad TA, Temple R, Rochester G (2009)
Top-tier peer-reviewed journal
Read the source: https://doi.org/10.1136/bmj.b2880
DOI: 10.1136/bmj.b2880
How this was scored
- Study design
- Meta-analysis of randomised trials
- Funding
- Funding not disclosed
- Published in
- Top-tier peer-reviewed journal
- Sample size
- 99,231
- Preregistered
- not recorded
- Conflicts disclosed
- Yes
- Independent of proponent
- not recorded
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published September 21, 2026.
Questions
How strong is the evidence behind this?
veisund rates this source "strong evidence". Well-supported by good-quality research. It scores 77 out of 100 on our published rubric. One caveat travels with that badge: Short trials that were not designed to measure suicidality; events identified retrospectively from adverse event reports. Trials exclude the most acutely suicidal patients. Absolute event rates were low in every age group. The score is calculated from recorded facts about the source — study design, funding, publication venue, sample size, preregistration — not typed in by an editor.
What is the source for this?
Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration — Stone M, Laughren T, Jones ML, Levenson M, Holland PC, Hughes A, Hammad TA, Temple R, Rochester G (2009). Published in: Top-tier peer-reviewed journal. DOI: 10.1136/bmj.b2880. The full source is linked on this page so you can read it yourself.
Who paid for this research, and does that matter?
Study design: Meta-analysis of randomised trials. Funding: Funding not disclosed. Independence from the proponent is not recorded. Industry sponsorship is one of the most reliably measured biases in medicine, which is why funding carries real weight in the score rather than sitting in a footnote.
Is this medical advice?
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.
This is information to bring to your prescriber, not medical advice and not a reason to change anything on your own. Nothing here is an instruction to stop or reduce a medication. If you are in crisis, call or text 988.