- Design
- Pragmatic single-blind SMART randomised trial, 24 weeks
- Population
- 316 youths aged 8 to 17 with DSM-5 anxiety disorders
- Primary outcome
- Youth-reported SCARED score
- Effect
- Initial CBT vs fluoxetine 1.45 (-2.25 to 5.16); combination vs continuation -2.74 (-6.53 to 1.05)
This pragmatic sequential multiple assignment randomised trial enrolled 316 young people aged 8 to 17 with severe anxiety disorders, many with high disadvantage and co-occurring diagnoses, from primary care and mental health clinics. They were randomised to fluoxetine or exposure-based CBT for 12 weeks; those not in remission were then randomised to continue or to add the other treatment.
Self-reported anxiety scores fell by 31.7% over 24 weeks. The starting treatment did not matter (difference 1.45, 95% CI -2.25 to 5.16, a non-significant edge for CBT). In week-12 non-remitters, combination did not beat continuing monotherapy (difference -2.74, -6.53 to 1.05). Some sequences separated on selected secondary measures, and subgroup patterns by ethnicity were reported.
For clinicians, this means the choice of first treatment can follow family preference and availability. It does not support routinely adding a second modality at 12 weeks.
- Offer either fluoxetine or exposure-based CBT first; outcomes were similar
- Let family preference and what is available locally guide the first choice
- In a child not in remission at 12 weeks, continuing the first treatment was as good as adding the other
- Expect about a one-third fall in self-reported symptoms over six months
Why it matters
Where CBT waiting lists are long, starting fluoxetine is not a second-best choice.
Don't overread it
The ethnicity differences are subgroup findings and should not guide individual treatment.
The statistics, in plain English
Both confidence intervals include zero, so neither difference is established. Subgroup results come from smaller numbers and multiple comparisons, making chance findings more likely.
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