Studying the Clinical Research Experiences of Patients With PTSD

NCT ID: NCT05840120

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-31

Study Completion Date

2026-05-31

Brief Summary

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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

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Conditions

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PTSD

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Power Life Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Gill

Role: STUDY_DIRECTOR

Power Life Sciences Inc.

Central Contacts

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Michael B Gill

Role: CONTACT

415-900-4227

References

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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.

Reference Type BACKGROUND
PMID: 24419308 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24035645 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26241600 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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80684805

Identifier Type: -

Identifier Source: org_study_id

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