Tracking Response in Advance of Investigational Trials, Borderline Study

NCT05025670 | Completed

• 1 other identifier: TRAIT-BOR-101
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  90 days

• The proportion of participants who fail to reach response to longer term monthly supportive psychotherapy treatment after 8 months.

  Up to 52 weeks

Other Outcomes (2)

• The initial prevalence of comorbid psychiatric symptoms as assessed by the Mini-International Neuropsychiatric Inventory (MINI).

  Up to 52 weeks

• 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.

  Up to 52 weeks

Interventions

Supportive psychotherapy BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adams Clinical: lead

Study Sites (1)

Adams Clinical

Watertown, Massachusetts, 02472, United States

Location

MeSH Terms

Conditions

Borderline Personality Disorder

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: August 27, 2021
• Study Start: August 5, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: March 27, 2023

Record last verified: 2023-03

Locations

US (1)