Borderline Personality DisorderNCT05989529
Delving Into Borderline Personality Disorder Clinical Trial Experiences
An observational study of Borderline Personality Disorder, run by Power Life Sciences Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Personality Disorder
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2024to Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged ≥ 18 years old
- Clinical diagnosis of Borderline Personality Disorder
- Able to comprehend the investigational nature of the protocol and provide informed consent
Who cannot join
- No diagnosis of Borderline Personality Disorder confirmed
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: Uncovering Clinical Trial Engagement Among Individuals With Borderline Personality Disorder
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
- Medical subject headings
- Borderline Personality Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who decide to enroll in a borderline personality disorder clinical research
Measured: 3 months
Rate of patients who remain in borderline personality disorder clinical research to trial completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989529
- Sponsor's protocol ID
- 80910613
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33890928Kvarstein 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.
PubMed 37229394Jacob 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.
PubMed 30559092
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncovering Clinical Trial Engagement Among Individuals With Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT05989529
- Acronym / sponsor ID
- 80910613
- Conditions
- Borderline Personality Disorder
- Keywords
- borderline personality disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Aged ≥ 18 years old
- Clinical diagnosis of Borderline Personality Disorder
- Able to comprehend the investigational nature of the protocol and provide informed consent
Key exclusion criteria (3 listed)
- No diagnosis of Borderline Personality Disorder confirmed
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Background: PubMed 33890928Garcia 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.
- Background: PubMed 37229394Kvarstein 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.
- Background: PubMed 30559092Jacob 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.
- Individual participant dataSharing planned: Undecided
Related trials for Borderline Personality Disorder
Recruiting
Repetitive Transcranial Magnetic Stimulation Versus Theta Burst Stimulation on Impulsivity, Emotional Dysregulation, and Non-Suicidal Self-Injury in Borderline Personality Disorder Patients
Borderline Personality Disorder (BPD)
Not yet recruitingPhase 2
Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder
Infusion of Ketamine in Severe Borderline Personality Disorder, Borderline Personality Disorder (BPD)
Recruiting
Combining Transcranial Magnetic Stimulation With Emotion Regulation Skills Training in Borderline Personality Disorder
Borderline Personality Disorder (BPD)
RecruitingPhase 2
MDMA in Borderline Personality Disorder
Borderline Personality Disorder
Active, not recruitingPhase 2
Mindfulness-based Neurofeedback to Augment Psychotherapy for Adults With Borderline Personality Disorder
Borderline Personality Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Gill study director
Power Life Sciences Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Borderline Personality Disorder, run by Power Life Sciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (415-900-4227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who decide to enroll in a borderline personality disorder clinical research (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05989529, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.