Response to acute monotherapy for major depressive disorder in randomized, placebo controlled trials submitted to the…
On average the drug-versus-placebo difference is modest but a minority of people respond strongly - how will we tell early on which group I am in?
Top of the evidence hierarchy, independently funded. how we score evidence
Caveat on this rating: Authors are FDA scientists analysing the agency's own trial database; no external funding was received.
Analysing individual data from 73,388 people in 232 placebo-controlled trials submitted to the FDA (including escitalopram's), antidepressants beat placebo by an average of 1.75 points on a 52-point depression scale, with roughly 15% of patients getting a substantial benefit beyond the placebo response.
Worth asking
On average the drug-versus-placebo difference is modest but a minority of people respond strongly - how will we tell early on which group I am in?
What it is FDA approved for
Read off the label. Trial duration and approval year are shown only where they were recorded — never inferred.
- Major depressive disorder (adults and pediatric patients 12 years and older)
- Generalized anxiety disorder (adults and pediatric patients 7 years and older)
Source
Response to acute monotherapy for major depressive disorder in randomized, placebo controlled trials submitted to the US Food and Drug Administration: individual participant data analysis — Stone MB, et al. (2022)
Top-tier peer-reviewed journal
Read the source: https://doi.org/10.1136/bmj-2021-067606
DOI: 10.1136/bmj-2021-067606
How this was scored
- Study design
- Meta-analysis of randomised trials
- Funding
- No external funding
- Published in
- Top-tier peer-reviewed journal
- Sample size
- 73,388
- Preregistered
- No
- Conflicts disclosed
- Yes
- Independent of proponent
- Yes
- Retracted
- No
Read the full scoring rubric, including what it can't tell you.
Published August 19, 2026.
Questions
How strong is the evidence behind this?
Resolv rates this source "gold standard". Top of the evidence hierarchy, independently funded. It scores 94 out of 100 on our published rubric. One caveat travels with that badge: Authors are FDA scientists analysing the agency's own trial database; no external funding was received. 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?
Response to acute monotherapy for major depressive disorder in randomized, placebo controlled trials submitted to the US Food and Drug Administration: individual participant data analysis — Stone MB, et al. (2022). Published in: Top-tier peer-reviewed journal. DOI: 10.1136/bmj-2021-067606. 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: No external funding. The researchers were independent of whoever benefits from the result. 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 escitalopram (Lexapro, Cipralex), lexapro, cipralex FDA approved?
Yes — FDA approved for Major depressive disorder (adults and pediatric patients 12 years and older), Generalized anxiety disorder (adults and pediatric patients 7 years and older). Approval is for a specific indication, not for everything the drug is prescribed for.
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.