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Delving Into Borderline Personality Disorder Clinical Trial Experiences

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05989529
Recruitment Status : Not yet recruiting
First Posted : August 14, 2023
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
Power Life Sciences Inc.

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Taking part in medical study usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This study will admit a wide range of data on the clinical research experience of borderline personality disorder patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future borderline personality disorder patients.


Condition or disease
Borderline Personality Disorder

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Uncovering Clinical Trial Engagement Among Individuals With Borderline Personality Disorder
Estimated Study Start Date : September 2024
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of patients who decide to enroll in a borderline personality disorder clinical research [ Time Frame: 3 months ]
  2. Rate of patients who remain in borderline personality disorder clinical research to trial completion [ Time Frame: 12 months ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with borderline personality disorder who are actively considering enrolling in an observational clinical trial but have not yet completed enrollment and randomization phases in said clinical trial.
Criteria

Inclusion Criteria:

  • Aged ≥ 18 years old
  • Clinical diagnosis of Borderline Personality Disorder
  • Able to comprehend the investigational nature of the protocol and provide informed consent

Exclusion Criteria:

  • No diagnosis of Borderline Personality Disorder confirmed
  • Inability to perform regular electronic reporting
  • Patient does not understand, sign, and return consent form
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05989529


Contacts
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Contact: Michael B Gill 415-900-4227 bask@withpower.com

Locations
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United States, California
Power Life Sciences
San Francisco, California, United States, 94107
Contact: Michael B Gill    415-900-4227    https://www.withpower.com/contact-us@withpower.com   
Sponsors and Collaborators
Power Life Sciences Inc.
Investigators
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Study Director: Michael B Gill Power Life Sciences Inc.
  Study Documents (Full-Text)

Documents provided by Power Life Sciences Inc.:
Informed Consent Form  [PDF] August 4, 2023

More Information
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Publications:

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Responsible Party: Power Life Sciences Inc.
ClinicalTrials.gov Identifier: NCT05989529    
Other Study ID Numbers: 80910613
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Power Life Sciences Inc.:
borderline personality disorder
Additional relevant MeSH terms:
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Personality Disorders
Borderline Personality Disorder
Mental Disorders