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5HTP Regulation Of Asthma In Children
NCT04160910Phase 2
Key facts
- Status
- Recruiting
- Start
- Feb 2021
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- Indiana University
- Modality
- Peptides, Small Molecules
- Drugs
- 5-hydroxytryptophan
- Conditions
- asthmaanxiety disordermajor depressive disorder (MDD)
01
Overview
Phase 2, randomised, double-blind trial in asthma, anxiety disorder and major depressive disorder (MDD) comparing 5-hydroxytryptophan with Placebo (2 arms). Primary endpoint: Forced Expiratory Volume at one second at 77 days. Started Feb 2021; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
5-hydroxytryptophan
50mg or 100mg twice a day based on weight
Placebo
Placebo twice a day based on weight
03
Who it enrols
Children aged 8-18 with mild to moderate allergic asthma, weighing at least 70 lbs, and exhibiting symptoms of anxiety/depression (CES-DC >= 15 or SCARED >= 25). Excludes patients taking SSRIs, leukotriene inhibitors, or biologic medications.
04
Endpoints
Primary
Forced Expiratory Volume at one second
Secondary
Blood Eosinophil Count
Symptoms for Anxiety/Depression
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