Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
SMART: Fluoxetine and CBT Sequencing in Youth Anxiety
NCT04760275Phase 3
Key facts
- Status
- Active, not recruiting
- Start
- Feb 2021
- Primary completion
- Feb 2025
- Countries
- 1
- Sponsor
- Children's Hospital Los Angeles
- Modality
- Small Molecules
- Drugs
- fluoxetine
- Conditions
- anxiety disorders
01
Overview
Phase 3, randomised, single-blind trial of fluoxetine in anxiety disorders (2 arms), sponsored by Children's Hospital Los Angeles. Primary endpoint: Screen for Child Anxiety Related Disorders (Youth) at Week 24. Started Feb 2021; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedSingle-blind
Medication - Fluoxetine
Fluoxetine starting at 10mg/day, titrated up to 80mg/day.
Cognitive Behavioral Therapy (CBT)
Coping Cat program, weekly sessions.
03
Who it enrols
Youths aged 8-17 with anxiety disorders (generalized, separation, panic, or social anxiety) and moderate severity. Excludes OCD, PTSD, Bipolar, Psychosis, and those on conflicting medications.
04
Endpoints
Primary
Screen for Child Anxiety Related Disorders (Youth)
Secondary
Screen for Child Anxiety Related Disorders (Parent)
Child Anxiety Impact Scale (Youth)
Child Anxiety Impact Scale (Parent)
Beyond the preview
Go deeper on NCT04760275.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT04760275.