Clinical trial NCT05025670: Tracking Response in Advance of Investigational Trials, Borderline Study
Official title: Tracking Response in Advance of Investigational Trials, Borderline Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Borderline Personality Disorder
Lead sponsor: Adams Clinical
Sponsor class: NETWORK
First posted: 2021-08-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. The current study seeks to determine if there are therapeutic benefits to more infrequent, short term, or longer term supportive psychotherapy.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
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.
timeFrame: 90 days
measure: 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.
timeFrame: 90 days
measure: 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.
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: 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.
timeFrame: 90 days
measure: 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.
timeFrame: Up to 52 weeks
measure: 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.
timeFrame: Up to 52 weeks
measure: The proportion of participants who fail to reach response to a brief course of monthly supportive psychotherapy treatment after 3 months.
timeFrame: 90 days
measure: The proportion of participants who fail to reach response to longer term monthly supportive psychotherapy treatment after 8 months.
timeFrame: Up to 52 weeks
measure: The proportion of participants who show a partial response to monthly brief or longer term supportive psychotherapy treatment.
timeFrame: Up to 52 weeks
measure: The proportion of participants who show a clinically significant response to brief monthly supportive psychotherapy treatment.
timeFrame: 90 days
measure: The proportion of participants who show a clinically significant response to longer term monthly supportive psychotherapy treatment.
timeFrame: Up to 52 weeks
Other outcomes:
measure: The initial prevalence of comorbid psychiatric symptoms as assessed by the Mini-International Neuropsychiatric Inventory (MINI).
timeFrame: Up to 52 weeks
measure: The proportion of participants who elect to add psychopharmacologic treatment to their monthly supportive psychotherapy by enrolling in an industry-sponsored clinical trial for BPD at the site.
timeFrame: Up to 52 weeks
Locations:
city: Watertown
country: United States
facility: Adams Clinical
state: Massachusetts
Study officials:
References: