In children and teenagers, only one antidepressant clearly beat placebo

Across 34 trials of 14 antidepressants in under-18s, only fluoxetine was statistically better than placebo - and only just.

gold standard94/100

Top of the evidence hierarchy, independently funded. how we score evidence

FDA approvedfluoxetine (Prozac, Sarafem)prozacsarafem

Cipriani, Zhou and colleagues pooled every double-blind trial of antidepressants for major depression in under-18s. They searched regulator websites and trial registers too, to catch unpublished results.

Significant findings

34 trials, 5,260 young people, 14 drugs - and one drug that beat placebo. Fluoxetine's margin nearly touched zero.

Tolerability separated the drugs more than benefit did. Imipramine, venlafaxine and duloxetine all caused more dropouts for side effects than placebo, imipramine at over five times the placebo rate.

The caution runs both ways. Evidence quality was rated very low in most comparisons - small trials, mostly industry-funded, at high or unclear risk of bias.

That makes the negative results about individual drugs almost as uncertain as the positive one. The honest reading is that the evidence here is thin, not that these drugs are known to fail.

This covers acute treatment only, typically eight to twelve weeks. It says nothing about staying on them.

Worth asking

What did we try before this, what exactly are we measuring, and is therapy running alongside?

Never stop or change a prescribed antidepressant on your own. Abrupt stops can be dangerous, and any change needs a prescriber-supervised taper.

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 (acute and maintenance treatment)
  • Obsessive-compulsive disorder
  • Bulimia nervosa (moderate to severe; binge-eating and vomiting behaviors)
  • Panic disorder, with or without agoraphobia
  • Depressive episodes associated with bipolar I disorder (in combination with olanzapine)
  • Treatment-resistant depression (in combination with olanzapine)

Source

Comparative efficacy and tolerability of antidepressants for major depressive disorder in children and adolescents: a network meta-analysis — Cipriani A, et al. (2016)

Top-tier peer-reviewed journal

Read the source: https://doi.org/10.1016/S0140-6736(16)30385-3

DOI: 10.1016/S0140-6736(16)30385-3

How this was scored

Study design
Meta-analysis of randomised trials
Funding
Independently funded
Published in
Top-tier peer-reviewed journal
Sample size
5,260
Preregistered
Yes
Conflicts disclosed
No
Independent of proponent
Yes
Retracted
No

Read the full scoring rubric, including what it can't tell you.

Published August 19, 2026. Last verified August 31, 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. 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?

Comparative efficacy and tolerability of antidepressants for major depressive disorder in children and adolescents: a network meta-analysis — Cipriani A, et al. (2016). Published in: Top-tier peer-reviewed journal. DOI: 10.1016/S0140-6736(16)30385-3. 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 fluoxetine (Prozac, Sarafem), prozac, sarafem FDA approved?

Yes — FDA approved for Major depressive disorder (acute and maintenance treatment), Obsessive-compulsive disorder, Bulimia nervosa (moderate to severe; binge-eating and vomiting behaviors), Panic disorder, with or without agoraphobia, Depressive episodes associated with bipolar I disorder (in combination with olanzapine), Treatment-resistant depression (in combination with olanzapine). 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.