Borderline Personality DisorderTRAIT-BORNCT05025670
Tracking Response in Advance of Investigational Trials, Borderline Study
An observational study of Borderline Personality Disorder, run by Adams Clinical at 1 site in United States.
Trial summary
TRAIT-BOR is an open-label psychotherapy treatment study for adults who meet the diagnostic criteria for Borderline Personality Disorder (BPD) and are seeking enrollment in a clinical trial of a novel compound to treat BPD. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Supportive psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2021to 15 Dec 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults aged 18 to 65 years old, who meet criteria for BPD, and who have expressed interest in participating in a clinical trial of an investigational product for treatment of BPD.
Who may be able to join
- Participant has signed an ICF prior to any study-specific procedures being performed.
- Participant has a diagnosis of Borderline Personality Disorder, per DSM-5 criteria, as confirmed on the MINI, and ≥ 16 AAPI-CR total score.
- Participant is in good physical health, and, in the opinion of the investigator, is a suitable candidate for treatment with monthly supportive psychotherapy.
- Participant is 18 to 65 years old.
- For participants already receiving psychotherapy, including Dialectical Behavioral Therapy (DBT), they must continue their regular course of treatment for the duration of the current study.
Who cannot join
- Participant is pregnant, breast-feeding, or planning to become pregnant.
- A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality, which in the opinion of the investigator may impact participant safety or study results.
- Participant has a history of any psychiatric condition other than BPD, which in the opinion of the investigator is primary, or any other psychiatric or neurologic disorder or symptom that could pose undue risk to the participant or compromise the study.
- Any participant who represents an acute suicidal risk in the opinion of the investigator, as defined by a "yes" response to suicidal ideation on questions 4 or 5, or answer "yes" to suicidal behavior questions on the CSSR-S within 90 days of screening.
- Any participant who represents an acute homicidal risk in the opinion of the investigator.
- Moderate or severe substance use disorder within 90 days prior to screen, according to DSM-5 criteria that in the opinion of the investigator could pose undue risk to the participant, or compromise the study.
- Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study.
- Participants who require ongoing treatment with typical antipsychotics.
Trial locations and contacts
1 site in 1 country.
About this study
TRAIT-BOR is an open-label psychotherapy treatment study for adults who meet the diagnostic criteria for Borderline Personality Disorder (BPD) and are seeking enrollment in a clinical trial of a novel compound to treat BPD. The current study seeks to determine if there are therapeutic benefits to more infrequent, short term, or longer term supportive psychotherapy.
- Conditions
- Borderline Personality Disorder
- Being tested
- Supportive psychotherapy
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive psychotherapyBehavioural
Participants will receive monthly 30-45 minute supportive psychotherapy sessions. Supportive psychotherapy is an integrative and eclectic psychotherapeutic approach, based upon the individual's needs and symptoms. It draws from elements of a variety of psychotherapeutic disciplines, including cognitive-behavior, psychodynamic, and interpersonal therapies.
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of symptoms and treatment response as defined as change in total scores on the Agitation-Aggression Psychiatric Inventory - Clinician Report (AAPI-CR) from Baseline/Day 0 to End of Cycle (EOC)/Day 90.
Total scores on the AAPI-CR range from 11 to 275, with higher scores indicating higher levels of agitation and aggression.
Measured: 90 days
Stability of symptoms and treatment response as defined as change in total scores on the self-report Borderline Personality Disorder Checklist (BPDCL) from Baseline/Day 0 to End of Cycle (EOC)/Day 90.
Total scores on the BPDCL range from 47 to 235, with higher scores indicating greater symptom severity.
Measured: 90 days
The proportion of participants who have clinically significant agitation and aggression symptoms, as defined as AAPI-CR Agitation and Aggression (A/A) subscale score ≥ 16 and sum of the A/A subscale severity scores ≥ 6.
Measured: Up to 52 weeks
Secondary outcomes (8)
Stability of symptoms and treatment response as defined as change in total score on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) from Baseline/Day 0 to End of Cycle (EOC)/Day 90.
Total scores on the ZAN-BPD range from 0 to 36, with higher scores indicating greater symptom severity.
Measured: 90 days
Stability of symptoms and treatment response as defined as change in total scores on the AAPI-CR from Baseline/Day 0 to End of Study (EOS)/Day 224.
Measured: Up to 52 weeks
Stability of symptoms and treatment response as defined as change in total scores on the BPDCL from Baseline/Day 0 to End of Study (EOS)/Day 224.
Measured: Up to 52 weeks
The proportion of participants who fail to reach response to a brief course of monthly supportive psychotherapy treatment after 3 months.
Defined as either AAPI-CR Total score ≥ 16 by EOC/Day 90 or < 25% decrease in AAPI-CR Total Score from Baseline/Day 0 to EOC/Day 90 and verified by clinician-rated assessment as indicated by a CGI ≥ 4 at EOC/Day 90.
Measured: 90 days
The proportion of participants who fail to reach response to longer term monthly supportive psychotherapy treatment after 8 months.
Defined as either AAPI-CR Total score ≥ 16 by EOS/Day 224 or < 25% decrease in AAPI-CR Total Score from Baseline/Day 0 to EOS/Day 224 and verified by clinician-rated assessment as indicated by a CGI ≥ 4 at EOS/Day 224.
Measured: Up to 52 weeks
The proportion of participants who show a partial response to monthly brief or longer term supportive psychotherapy treatment.
Defined as ≥ 25% to < 50% reduction in AAPI-CR Total Score from Baseline/Day 0 to EOC/Day 90 and ≥ 25% to < 50% reduction in AAPI-CR Total Score from Baseline/Day 0 to EOS/Day 224.
Measured: Up to 52 weeks
The proportion of participants who show a clinically significant response to brief monthly supportive psychotherapy treatment.
Defined as ≥ 50% reduction in AAPI-CR Total Score from Baseline/Day 0 to EOC/Day 90 and verified by clinician-rated assessment as indicated by a CGI ≤ 3 at EOC/Day 90.
Measured: 90 days
The proportion of participants who show a clinically significant response to longer term monthly supportive psychotherapy treatment.
Defined as ≥ 50% reduction in AAPI-CR Total Score from Baseline/Day 0 to EOS/Day 224 and verified by clinician-rated assessment as indicated by a CGI ≤ 3 at EOS/Day 224.
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start5 Aug 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adams Clinical
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025670
- Sponsor's protocol ID
- TRAIT-BOR-101
- Acronym
- TRAIT-BOR
- Status last verified
- Mar 2023
- First submitted
- 20 Aug 2021
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking Response in Advance of Investigational Trials, Borderline Study
- ClinicalTrials.gov ID
- NCT05025670
- Acronym / sponsor ID
- TRAIT-BOR / TRAIT-BOR-101
- Conditions
- Borderline Personality Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Adams ClinicalResearch network
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 27 Aug 2021 (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.
TRAIT-BOR is an open-label psychotherapy treatment study for adults who meet the diagnostic criteria for Borderline Personality Disorder (BPD) and are seeking enrollment in a clinical trial of a novel compound to treat BPD. The current study seeks to determine if there are therapeutic benefits to more infrequent, short term, or longer term supportive psychotherapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 to 65 years old, who meet criteria for BPD, and who have expressed interest in participating in a clinical trial of an investigational product for treatment of BPD.
Key inclusion criteria (5 listed)
- Participant has signed an ICF prior to any study-specific procedures being performed.
- Participant has a diagnosis of Borderline Personality Disorder, per DSM-5 criteria, as confirmed on the MINI, and ≥ 16 AAPI-CR total score.
- Participant is in good physical health, and, in the opinion of the investigator, is a suitable candidate for treatment with monthly supportive psychotherapy.
- Participant is 18 to 65 years old.
- For participants already receiving psychotherapy, including Dialectical Behavioral Therapy (DBT), they must continue their regular course of treatment for the duration of the current study.
Key exclusion criteria (8 listed)
- Participant is pregnant, breast-feeding, or planning to become pregnant.
- A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality, which in the opinion of the investigator may impact participant safety or study results.
- Participant has a history of any psychiatric condition other than BPD, which in the opinion of the investigator is primary, or any other psychiatric or neurologic disorder or symptom that could pose undue risk to the participant or compromise the study.
- Any participant who represents an acute suicidal risk in the opinion of the investigator, as defined by a "yes" response to suicidal ideation on questions 4 or 5, or answer "yes" to suicidal behavior questions on the CSSR-S within 90 days of screening.
- Any participant who represents an acute homicidal risk in the opinion of the investigator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supportive psychotherapyParticipants will receive monthly 30-45 minute supportive psychotherapy sessions. Supportive psychotherapy is an integrative and eclectic psychotherapeutic approach, based upon the individual's needs and symptoms. It draws from elements of a variety of psychotherapeutic disciplines, including cognitive-behavior, psychodynamic, and interpersonal therapies. | Behavioural | – |
Primary outcome
Stability of symptoms and treatment response as defined as change in total scores on the Agitation-Aggression Psychiatric Inventory - Clinician Report (AAPI-CR) from Baseline/Day 0 to End of Cycle (EOC)/Day 90.
Time frame: 90 days
Total scores on the AAPI-CR range from 11 to 275, with higher scores indicating higher levels of agitation and aggression.
Stability of symptoms and treatment response as defined as change in total scores on the self-report Borderline Personality Disorder Checklist (BPDCL) from Baseline/Day 0 to End of Cycle (EOC)/Day 90.
Time frame: 90 days
Total scores on the BPDCL range from 47 to 235, with higher scores indicating greater symptom severity.
The proportion of participants who have clinically significant agitation and aggression symptoms, as defined as AAPI-CR Agitation and Aggression (A/A) subscale score ≥ 16 and sum of the A/A subscale severity scores ≥ 6.
Time frame: Up to 52 weeks
8 secondary outcomes
Stability of symptoms and treatment response as defined as change in total score on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) from Baseline/Day 0 to End of Cycle (EOC)/Day 90.
Time frame: 90 days
Stability of symptoms and treatment response as defined as change in total scores on the AAPI-CR from Baseline/Day 0 to End of Study (EOS)/Day 224.
Time frame: Up to 52 weeks
Stability of symptoms and treatment response as defined as change in total scores on the BPDCL from Baseline/Day 0 to End of Study (EOS)/Day 224.
Time frame: Up to 52 weeks
The proportion of participants who fail to reach response to a brief course of monthly supportive psychotherapy treatment after 3 months.
Time frame: 90 days
The proportion of participants who fail to reach response to longer term monthly supportive psychotherapy treatment after 8 months.
Time frame: Up to 52 weeks
The proportion of participants who show a partial response to monthly brief or longer term supportive psychotherapy treatment.
Time frame: Up to 52 weeks
The proportion of participants who show a clinically significant response to brief monthly supportive psychotherapy treatment.
Time frame: 90 days
The proportion of participants who show a clinically significant response to longer term monthly supportive psychotherapy treatment.
Time frame: Up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Adams Clinical 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 27 Mar 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability of symptoms and treatment response as defined as change in total scores on the Agitation-Aggression Psychiatric Inventory - Clinician Report (AAPI-CR) from Baseline/Day 0 to End of Cycle (EOC)/Day 90. (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2023.