Delving Into Borderline Personality Disorder Clinical Trial Experiences

NCT05989529 | Not Yet Recruiting

• 1 other identifier: 80910613
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Keywords

borderline personality disorder

Outcome Measures

Primary Outcomes (2)

• Number of patients who decide to enroll in a borderline personality disorder clinical research

  3 months

• Rate of patients who remain in borderline personality disorder clinical research to trial completion

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• No diagnosis of Borderline Personality Disorder confirmed
• Inability to perform regular electronic reporting
• Patient does not understand, sign, and return consent form

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

• Garcia MC. [Treatment of borderline personality disorder with opioid antagonists: buprenorphine, nalmefene, naloxone and naltrexone in the treatment of dissociative symptoms, self-mutilation and suicidal behavior]. Vertex. 2020 Apr;XXX(148):1-10. doi: 10.53680/vertex.v30i148.122. Spanish.

  PMID: 33890928 BACKGROUND

• Kvarstein EH, Froyhaug M, Pettersen MS, Carlsen S, Ekberg A, Fjermestad-Noll J, Ulvestad DA, Gikling EL, Hjermann E, Lindberget K, Omvik S, Eikenaes IU, Hummelen B, Morken KTE, Wilberg T, Pedersen GAF. Improvement of personality functioning among people treated within personality disorder mental health services. A longitudinal, observational study. Front Psychiatry. 2023 May 9;14:1163347. doi: 10.3389/fpsyt.2023.1163347. eCollection 2023.

  PMID: 37229394 BACKGROUND

• Jacob GA, Hauer A, Kohne S, Assmann N, Schaich A, Schweiger U, Fassbinder E. A Schema Therapy-Based eHealth Program for Patients with Borderline Personality Disorder (priovi): Naturalistic Single-Arm Observational Study. JMIR Ment Health. 2018 Dec 17;5(4):e10983. doi: 10.2196/10983.

  PMID: 30559092 BACKGROUND

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

415-900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

US (1)