Studying the Clinical Research Experiences of Patients Wi... | NCT05840120

Studies
Studying the Clinical Research Experiences of Patients With PTSD

NCT05840120

Sponsor

Power Life Sciences Inc.

Status

Unknown status

Last Update Posted

May 3, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

PTSD

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2024Estimated

Primary Completion Date

May 2025Estimated

Completion Date

May 2026Estimated

First Submitted Date

Apr 21, 2023

First Submission Date that Met QC Criteria

Apr 21, 2023

First Posted Date

May 3, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2023

Last Update Posted Date

May 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

PTSD patients who are actively considering involvement in an observational clinical trial, but have not yet completed enrollment and registration.

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Michael B Gill	Contact	415-900-4227		bask@withpower.com

Name	Affiliation	Role
Michael B Gill	Power Life Sciences Inc.	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24419308	Background	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.
24035645	Background	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.

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders