Studying the Clinical Research Experiences of Patients With PTSD

PTSD Clinical Trial

Official title:

PTSD Clinical Trials Review: Examining Patient Experiences in PTSD Clinical Trials to Identify Influencing Factors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05840120
• Other study ID #: 80684805
• Status: Not yet recruiting
• Start date: May 2024
• Est. completion date: May 2026

Study information

• Verified date: April 2023
• Source: Power Life Sciences Inc.
• Contact: Michael B Gill
• Phone: 415-900-4227
• Email: bask[@]withpower.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Clinical research participation percentages haven't always been fully representative of a given demographic.

The goal is to find out which aspects of a clinical study may make it more difficult for patients to take part or see it through.

The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future PTSD patients during clinical trials.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have a medical diagnosis of PTSD that has been confirmed by a physician.

• Aged = 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed.

• Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study.

Exclusion Criteria:

• Pregnant or lactating woman

• Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent.

• Known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Power Life Sciences Inc.

References & Publications (3)

Ronconi JM, Shiner B, Watts BV. Inclusion and exclusion criteria in randomized controlled trials of psychotherapy for PTSD. J Psychiatr Pract. 2014 Jan;20(1):25-37. doi: 10.1097/01.pra.0000442936.23457.5b. — View Citation

Sofuoglu M, Rosenheck R, Petrakis I. Pharmacological treatment of comorbid PTSD and substance use disorder: recent progress. Addict Behav. 2014 Feb;39(2):428-33. doi: 10.1016/j.addbeh.2013.08.014. Epub 2013 Aug 22. — View Citation

Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients who decide to enroll in a PTSD medical study.		3 months
Primary	Number of PTSD patients who remain in clinical trial until completion.		12 months