NCT06563466 PEGASUS - Improving Treatment for Patients With Emotionally Unstable Personality Disorder
| NCT ID | NCT06563466 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Bispebjerg and Frederiksberg |
| Condition | Borderline Personality Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-09-01 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the PEGASUS study is to conduct a pilot trial to test the feasibility and acceptability of the PEGASUS intervention, adding a case manager and family-based interventions meetings to the existing psychiatric integrated care-models known as "Treatment Packages" in Denmark. We will conduct a randomized, assessor-blinded parallel-groups superiority clinical trial, testing the PEGASUS intervention for emotionally unstable personality disorder "EUPD", borderline type (borderline personality disorder) compared to "Treatment as Usual" before moving on to testing in a full-scale trial. Participants will be assessed at baseline and 9 month post baseline at study conclusion
Eligibility Criteria
Participating Patients Inclusion Criteria: * Must be able to give an informed written consent. * Must be newly accepted in the pre-planned BPD treatment packages. * ≥18 years of age. * Agreeing to involvement of one or two informal caregivers, families, or close friends ("Relatives"). * Capable of reading and understanding Danish. Exclusion Criteria: * None\* * Note that to get accepted into a treatment package for BPD, patients must not fulfill the criteria for a F20 diagnosis or the criteria for alcohol or substance abuse or harmful use. Participating Relatives: Inclusion Criteria: * Must be able to give an informed written consent. * ≥18 years of age. * Capable of reading and understanding Danish. Exclusion criteria: None
Contact & Investigator
Carsten Hjorthøj, Ph.d.
PRINCIPAL INVESTIGATOR
Copenhagen Research Center for Mental Health
Frequently Asked Questions
Who can join the NCT06563466 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Borderline Personality Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06563466 currently recruiting?
Yes, NCT06563466 is actively recruiting participants. Contact the research team at ditte.hoeyer.rotvig@regionh.dk for enrollment information.
Where is the NCT06563466 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT06563466 clinical trial?
NCT06563466 is sponsored by University Hospital Bispebjerg and Frederiksberg. The principal investigator is Carsten Hjorthøj, Ph.d. at Copenhagen Research Center for Mental Health. The trial plans to enroll 100 participants.