NCT05636878 - 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)

Alla F, Guillemin F, Colombo MC, Roy B, Maeder C
[Diagnostic value of ERTL4: a screening test of language disorders in 4-year-old children]. Arch Pediatr. 1998 Oct;5(10):1082-8. doi: 10.1016/s0929-693x(99)80004-9. French.
Antenatal and postnatal mental health: clinical management and service guidance
London: National Institute for Health and Care Excellence (NICE); 2018 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK553127/
Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M; Medical Research Council Guidance
Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008 Sep 29;337:a1655. doi: 10.1136/bmj.a1655.
Dupont C, Touzet S, Ploin D, Croidieu C, Balsan M, Mazas AS, Rudigoz RC
[Evaluation of the perinatal network professionals' integration: study about 653 professionals of AURORE network]. J Gynecol Obstet Biol Reprod (Paris). 2007 Jun;36(4):375-83. doi: 10.1016/j.jgyn.2007.01.003. Epub 2007 Feb 20. French.

Creation and Evaluation of a Mobile Intervention Team in Perinatal Psychiatry (0-3 Years) in Meurthe-et-Moselle Sud

Clinical trial NCT05636878 - References