NCT05290285 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Buondonno I, Sassi F, Carignano G, Dutto F, Ferreri C, Pili FG, Massaia M, Nisoli E, Ruocco C, Porrino P, Ravetta C, Riganti C, Isaia GC, D'Amelio P
From mitochondria to healthy aging: The role of branched-chain amino acids treatment: MATeR a randomized study. Clin Nutr. 2020 Jul;39(7):2080-2091. doi: 10.1016/j.clnu.2019.10.013. Epub 2019 Oct 18.
Dalle Grave R, Calugi S, Conti M, Doll H, Fairburn CG
Inpatient cognitive behaviour therapy for anorexia nervosa: a randomized controlled trial. Psychother Psychosom. 2013;82(6):390-8. doi: 10.1159/000350058. Epub 2013 Sep 20.
El Ghoch M, Pourhassan M, Milanese C, Müller MJ, Calugi S, Bazzani PV, Dalle Grave R
Changes in lean and skeletal muscle body mass in adult females with anorexia nervosa before and after weight restoration. Clin Nutr. 2017 Feb;36(1):170-178. doi: 10.1016/j.clnu.2015.10.006. Epub 2015 Oct 28.
Fairburn CG, Cooper Z, Shafran R
Cognitive behaviour therapy for eating disorders: a "transdiagnostic" theory and treatment. Behav Res Ther. 2003 May;41(5):509-28.
Israely M, Ram A, Brandeis R, Alter Z, Avraham Y, Berry EM
A Double Blind, Randomized Cross-Over Trial of Tyrosine Treatment on Cognitive Function and Psychological Parameters in Severe Hospitalized Anorexia Nervosa Patients. Isr J Psychiatry. 2017;54(3):52-58.

Efficacy and Tolerability of a Specific Blend of Amino Acids in Patients With Anorexia Nervosa Treated in a Hospital Setting. Double-blind Randomized Study Versus Placebo

Details for clinical trial NCT05290285

Clinical trial NCT05290285 - References