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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06146049
Other study ID # 65314844
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2024
Est. completion date December 2026

Study information

Verified date November 2023
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone 4159004227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Participation in post traumatic stress disorder observational study serves as a crucial contribution to advancing medical knowledge and refining the care provided to individuals facing similar health challenges. The primary objective centers on a meticulous examination of trial completion rates and voluntary withdrawals within this distinct patient population.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date December 2026
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of post traumatic stress disorder - No prior treatment for post traumatic stress disorder - Willing and able to provide informed consent. Exclusion Criteria: - Enrolled in another research study - Psychiatric or behavioral illness - Inability to provide written informed consent

Study Design


Locations

Country Name City State
United States Power Life Sciences San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Power Life Sciences Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of patients who decide to enroll in a post traumatic stress disorder clinical research. 3 months
Primary Number of post traumatic stress disorder study participants who remain in clinical study until completion. 12 months
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