Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence
Paroxetine is not recommended for people under 18 - given my age and history, what makes it the right SSRI for me rather than one with a cleaner record?
Top of the evidence hierarchy, independently funded. how we score evidence
Caveat on this rating: Two reanalysis authors have served as paid expert witnesses against GSK in paroxetine litigation (disclosed); the original GSK-funded 2001 report claimed efficacy and remains unretracted but disputed.
An independent reanalysis of GlaxoSmithKline's Study 329 (275 adolescents) found paroxetine was no more effective than placebo for adolescent depression and was associated with clinically significant increases in suicidal ideation and behaviour - reversing the original 2001 publication's conclusions.
Worth asking
Paroxetine is not recommended for people under 18 - given my age and history, what makes it the right SSRI for me rather than one with a cleaner record?
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
Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence — Le Noury J, et al. (2015)
Top-tier peer-reviewed journal
Read the source: https://doi.org/10.1136/bmj.h4320
DOI: 10.1136/bmj.h4320
How this was scored
- Study design
- Randomised controlled trial
- Funding
- No external funding
- Published in
- Top-tier peer-reviewed journal
- Sample size
- 275
- Preregistered
- Yes
- 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.
Where we put this study in context
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: Two reanalysis authors have served as paid expert witnesses against GSK in paroxetine litigation (disclosed); the original GSK-funded 2001 report claimed efficacy and remains unretracted but disputed. 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?
Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence — Le Noury J, et al. (2015). Published in: Top-tier peer-reviewed journal. DOI: 10.1136/bmj.h4320. 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: Randomised controlled trial. 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 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.