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This study tests a new treatment for people with borderline personality disorder (BPD). The treatment combines a medication called D-cycloserine with one day of transcranial magnetic stimulation (TMS).
The main questions it aims to answer are:
Participants will be asked to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS + D-cycloserine | Experimental | Open-label combination of TMS and D-cycloserine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TMS | Device | TMS will consist of 600 pulses of intermittent theta burst stimulation (iTBS), with 3-minute treatment sessions delivered up to 20 times every 30 minutes for a 12-hour protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of Intervention Measure (AIM) | Feasibility of the one-day TMS treatment will be indexed by favorable ratings on the Acceptability of Intervention Measure (AIM). The AIM is a four-item measure that assesses participants' approval of an intervention. Each item is rated on a 5-point scale (completely disagree - completely agree), and total scores indicate greater acceptance of an intervention. | Week 5 |
| Motor-evoked potentials (MEPs) | MEPS will be recorded before and after treatment sessions 1, 2, 10, and the final session. Specifically, MEPS will be collected within 10 minutes before treatment session onset and within 5 minutes after treatment session completion. An increase in motor-evoked potentials (MEPs) over the TMS treatment course indicates increased plasticity. | Within 10 minutes pre- and 5 minutes post- treatment sessions 1,2,10,and final session |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Scale for Suicide Ideation - Self Report (MSSI-SR) | Suicidal ideation will be assessed using the MSSI-SR. The MSSI-SR is an 18-item self-report measure that assesses the frequency, intensity, and nature of suicidal ideation, plans, and intent across the past week. Responses range from 0 (e.g., does not experience thoughts of suicide) to 3 (e.g., experiences thoughts of suicide many times each day). Total score ranges from 0 to 54, with higher scores indicating greater suicide risk factors and more severe suicidal ideation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Velev, BA | Contact | 617-855-3430 | avelev@mclean.harvard.edu | |
| Molly Coyle, BS | Contact | 617-855-2153 | mcoyle3@mgb.org |
| Name | Affiliation | Role |
|---|---|---|
| Jenna M Traynor, PhD | Mclean Hospital | Principal Investigator |
| Joshua Brown, MD, PhD | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Recruiting | Belmont | Massachusetts | 02478 | United States |
This is an internal, Phase I study and there are no current plans to share IPD with personnel outside of Mass General Brigham (MGB). In the event that a decision is made in the future to share data from this research study with collaborators outside of MGB, data will be de-identified prior to sharing and will comply with all relevant MGB data sharing policies. The possibility that data may be shared with outside collaborators will be clearly outlined in the informed consent form.
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003523 | Cycloserine |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| D-Cycloserine (DCS) | Drug | Participants will be asked to take a single dose (250mg) of D-cycloserine the night before the treatment day. |
|
| From baseline through to week 11. Taken at week 1, week 3, week 6, week 8, week 10, and week 11, an average of once every two weeks |
| Distress Tolerance Scale (DTS) | The DTS is a 15-item self-report questionnaire assessing participant's beliefs about distressing or upsetting feelings on average. Responses range from 1 (strongly agree) to 5 (strongly disagree), and higher average total scores indicate greater distress tolerance. | From baseline through to week 11. Taken at week 1, week 2, week 4, week 7, week 9, and week 11, an average of once every two weeks |
| Rejection Sensitivity Questionnaire (RSQ) | The RSQ is an 18-item self-report measure that assesses the level of rejection concern and rejection expectancy an individual has in nine common hypothetical situations. Rejection concern scores range from 1 (very unconcerned) to 6 (very concerned), and rejection expectancy scores range from 1 (very unlikely) to 6 (very likely). Sensitivity scores (between 1 and 36) are produced for each situation by multiplying the two scores. The total score (between 1 and 36) represents the average of rejection sensitivity scores across the situations, with higher scores indicating greater rejection sensitivity. | From baseline through to week 11. Taken at week 1, week 7, and week 11 |
| The Brief Version of the Mentalization Scale (MentS-12) | The MentS-12 is a 12-item self-report measure that assesses an individual's mentalization capacity across self-related mentalization, other-related mentalization, and motivation to mentalize. Responses range from 1 (completely incorrect) to 5 (completely correct), and total higher summed score indicates greater mentalizing capacity. | From baseline through to week 11. Taken at week 1, week 7, and week 11 |
| Social Safeness and Pleasure Scale (SSPS) | The SPSS is an 11-item self-report measure that assesses the extent to which participants experience their social worlds as safe, warm, and soothing. Responses range from 1 (almost never) to 5 (almost all the time), and total scores range from 11 to 55, with higher scores indicating greater positive feelings in social relationships. | From baseline through to week 11. Taken at week 1, week 7, and week 11 |
| Borderline Symptom List 23 (BSL-23) | The BSL-23 is a self-report measure that Assesses how much participants suffered from experiences related to BPD. Responses range from 0 (not at all) to 4 (very strong). The total score (0-4) is the average of the 23 items, with higher scores indicating greater BPD symptom severity. | From baseline through to week 11. Taken at week 1, week 7, and week 11 |
| Patient Health Questionnaire 9 (PHQ-9) | The PHQ-9 is a 9-item self-report measure that assesses depression severity over the past 2 weeks (or otherwise specified). Responses range from 0 (not at all) to 3 (nearly every day), along with a final question about how difficult the endorsed problems made it difficult to do work, take care of things at home, or get along with others (ranging from not difficult at all - extremely difficult). Total summed score indicates depression severity, with higher scores suggesting greater depression severity | From baseline through to week 11. Taken at week 1, week 7, and week 11 |
| D023303 |
| Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |