NCT06146049 - 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)

Casarin J, Ielmini M, Cromi A, Lagana AS, Poloni N, Callegari C, Ghezzi F
Post-traumatic stress following total hysterectomy for benign disease: an observational prospective study. J Psychosom Obstet Gynaecol. 2022 Mar;43(1):11-17. doi: 10.1080/0167482X.2020.1752174. Epub 2020 Apr 22.
Cenkner DP, Asnaani A, DiChiara C, Harb GC, Lynch KG, Greene J, Scott JC
Neurocognitive Predictors of Treatment Outcomes in Cognitive Processing Therapy for Post-traumatic Stress Disorder: Study Protocol. Front Psychol. 2021 Jan 26;12:625669. doi: 10.3389/fpsyg.2021.625669. eCollection 2021.
Lai X, Chen J, Li H, Zhou L, Huang Q, Liao Y, Krewski D, Wen SW, Zhang L, Xie RH
The incidence of post-traumatic stress disorder following traumatic childbirth: A systematic review and meta-analysis. Int J Gynaecol Obstet. 2023 Jul;162(1):211-221. doi: 10.1002/ijgo.14643. Epub 2023 Jan 19.

Examination of Participation Trends and Engagement Patterns of Participants in Post Traumatic Stress Disorder Clinical Trials

Clinical trial NCT06146049 - References