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Not yet recruiting NCT05989529

Delving Into Borderline Personality Disorder Clinical Trial Experiences

Observational Borderline Personality Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Borderline Personality Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Uncovering Clinical Trial Engagement Among Individuals With Borderline Personality Disorder

Overview

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.

Primary outcome measures

  • Number of patients who decide to enroll in a borderline personality disorder clinical research [Time frame: 3 months]
  • Rate of patients who remain in borderline personality disorder clinical research to trial completion [Time frame: 12 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-crossover

Study locations

United States · 1 center
  • Power Life Sciences — San Francisco

Publications

  • 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
  • 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. PMID 37229394
  • 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

Identifiers

NCT: NCT05989529 · 80910613

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗