Effectiveness of paroxetine in the treatment of acute major depression in adults: a systematic re-examination of…
Unpublished trial data made paroxetine look weaker and riskier than the published record - how do you weigh that when prescribing it today?
Top of the evidence hierarchy, independently funded. how we score evidence
Caveat on this rating: Includes unpublished regulatory data, so its estimates are less flattering than published-only analyses; one author disclosed industry speaker fees.
Re-examining 40 published and unpublished placebo-controlled trials (6,391 adults), paroxetine was not superior to placebo on a combined measure of effectiveness and acceptability, and paroxetine patients more often stopped for side effects (77% higher risk) or experienced suicidal tendencies (odds 2.55 times higher).
Worth asking
Unpublished trial data made paroxetine look weaker and riskier than the published record - how do you weigh that when prescribing it today?
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)
- Obsessive-compulsive disorder (adults)
- Panic disorder (adults)
- Social anxiety disorder (adults)
- Generalized anxiety disorder (adults)
- Posttraumatic stress disorder (adults)
Source
Effectiveness of paroxetine in the treatment of acute major depression in adults: a systematic re-examination of published and unpublished data from randomized trials — Barbui C, et al. (2008)
Reputable peer-reviewed journal
Read the source: https://doi.org/10.1503/cmaj.070693
DOI: 10.1503/cmaj.070693
How this was scored
- Study design
- Meta-analysis of randomised trials
- Funding
- Independently funded
- Published in
- Reputable peer-reviewed journal
- Sample size
- 6,391
- 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 89 out of 100 on our published rubric. One caveat travels with that badge: Includes unpublished regulatory data, so its estimates are less flattering than published-only analyses; one author disclosed industry speaker fees. 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?
Effectiveness of paroxetine in the treatment of acute major depression in adults: a systematic re-examination of published and unpublished data from randomized trials — Barbui C, et al. (2008). Published in: Reputable peer-reviewed journal. DOI: 10.1503/cmaj.070693. 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: Independently funded. 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 paroxetine (Paxil, Pexeva, Brisdelle), paxil, pexeva, brisdelle FDA approved?
Yes — FDA approved for Major depressive disorder (adults), Obsessive-compulsive disorder (adults), Panic disorder (adults), Social anxiety disorder (adults), Generalized anxiety disorder (adults), Posttraumatic stress disorder (adults). 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.