Borderline Personality Disorder (BPD)Phase 1/2ONE-D BPDNCT07460947
A Pilot Trial of One-Day Accelerated TMS and D-cycloserine in Suicidal Patients With Borderline Personality Disorder
A Phase 1/2 study testing TMS and D-Cycloserine (DCS) in people with Borderline Personality Disorder (BPD), run by Mclean Hospital at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Borderline Personality Disorder (BPD)
- What is being tested?
- TMS and D-Cycloserine (DCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18+) of any gender
- Meets DSM-5 criteria for BPD, per assessment with the Structured Clinic Interview for DSM-5 Personality Disorders (SCID-5-PD), BPD Module
- Moderate to severe SI during the two weeks prior to screening, as indexed by a score of 9 or higher on the Modified Scale for Suicide Ideation - Self Report (Clum \& Yang, 1995)
Who cannot join
- Current manic or hypomanic symptoms, as assessed by the Diagnostic Assessment Research Tool (DART) screener and diagnostic modules, where relevant.
- Current clinically significant psychotic symptoms not better accounted for by BPD, as assessed by the DART psychotic symptoms screener.
- Current alcohol or substance use disorder, that in the opinion of a study PIs, is of sufficient severity to impede engagement in treatment or is associated with significant risk of medical withdrawal, as assessed by the DART.
- Medical documentation or self-report of current anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified - atypical anorexia nervosa or atypical bulimia nervosa, that is in the opinion of a study PIs is of sufficient severity to be associated with significant medical risks
- Acute suicide risk, sufficient to require immediate hospitalization;
- history of traumatic brain injury (TBI) or concussion involving loss of consciousness or amnesia for ≥24 hours;
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- any significant neurological disorder likely to be associated with increased intracranial pressure or cognitive impairment (e.g., epilepsy; Parkinson's disease);
- diagnosed neurodevelopmental disorder (e.g., autism, downs syndrome; Ehlers-Danlos Syndrome) other than attention-deficit hyperactivity disorder (ADHD) or dyslexia
- current diagnosis of delirium or dementia;
- cognitive disorder secondary to a general medical condition
- Pregnant and breastfeeding people are excluded in line with the studies our protocol is based upon using DCS and aTMS. Assessment of pregnancy will be completed during the 1-week prior to the administration of DCS (i.e., taken the night before TMS treatment), where relevant and according to MGB IRB policy.
- Participants with contraindications to TMS (e.g., metal in head or neck area), or at increased risk for adverse events (e.g., seizure history or markedly heightened risk factors for seizures, serious medical problems, implanted devices) will be excluded.
- Participants with a known allergy to DCS will be excluded from the study.
- No patients with involuntary hospitalization status will be recruited for the study.
- No individuals who are not proficient in English will be recruited for the study
- Subject does not have a PCP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
McLean Hospital
Belmont, Massachusetts, 02478
Alexandra L Velev, BA, avelev@mclean.harvard.edu
Molly Coyle, BS, mcoyle3@mgb.org
About this study
Official title: A Pilot Trial of One Day Accelerated Intermittent Theta-burst Stimulation Plus D-cycloserine in Suicidal Patients With Borderline Personality Disorder (ONE-D BPD)
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:
Read more
- How many participants complete the treatment?
- How do participants feel about the treatment?
- Does the treatment have neurophysiological changes on participants?
- Does the treatment improve BPD symptoms?
- Do the benefits last over time?
Participants will be asked to:
- Come to the clinic for interviews and testing
- Complete weekly questionnaires for 4 weeks before the treatment day
- Take D-cycloserine the night before treatment
- Attend one treatment day at the clinic. On that day, they may receive up to 20 short TMS sessions (each lasting 3 minutes and separated by 30 minutes). This visit may last up to 12 hours.
- Complete weekly questionnaires for 6 weeks after the treatment day.
- Conditions
- Borderline Personality Disorder (BPD)
- Being tested
- TMS, D-Cycloserine (DCS)
- 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.
TMSDevice
Also called iTBS
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.
D-Cycloserine (DCS)Drug
Participants will be asked to take a single dose (250mg) of D-cycloserine the night before the treatment day.
| Study group | Role | What they receive |
|---|---|---|
| TMS + D-cycloserine | Experimental | Open-label combination of TMS and D-cycloserine Receives: Device: TMS; Drug: D-Cycloserine (DCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 10 minutes pre- and 5 minutes post- treatment sessions 1,2,10,and final session
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From baseline through to week 11. Taken at week 1, week 7, and week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start10 Jun 2026
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline Personality Disorder (BPD)Studies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenna M. Traynor, Mclean Hospital
- Investigators
- Jenna M Traynor, PhD, Principal investigator, Mclean HospitalJoshua Brown, MD, PhD, Principal investigator, Mclean Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460947
- Sponsor's protocol ID
- 2025P001818
- Acronym
- ONE-D BPD
- Status last verified
- Aug 2026
- First submitted
- 5 Feb 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of One Day Accelerated Intermittent Theta-burst Stimulation Plus D-cycloserine in Suicidal Patients With Borderline Personality Disorder (ONE-D BPD)
- ClinicalTrials.gov ID
- NCT07460947
- Acronym / sponsor ID
- ONE-D BPD / 2025P001818
- Conditions
- Borderline Personality Disorder (BPD)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Mar 2026 (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.
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:
- How many participants complete the treatment?
- How do participants feel about the treatment?
- Does the treatment have neurophysiological changes on participants?
- Does the treatment improve BPD symptoms?
- Do the benefits last over time?
Participants will be asked to:
- Come to the clinic for interviews and testing
- Complete weekly questionnaires for 4 weeks before the treatment day
- Take D-cycloserine the night before treatment
- Attend one treatment day at the clinic. On that day, they may receive up to 20 short TMS sessions (each lasting 3 minutes and separated by 30 minutes). This visit may last up to 12 hours.
- Complete weekly questionnaires for 6 weeks after the treatment day.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMS + D-cycloserine | Experimental | Device: TMS, Drug: D-Cycloserine (DCS)Open-label combination of TMS and D-cycloserine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (18+) of any gender
- Meets DSM-5 criteria for BPD, per assessment with the Structured Clinic Interview for DSM-5 Personality Disorders (SCID-5-PD), BPD Module
- Moderate to severe SI during the two weeks prior to screening, as indexed by a score of 9 or higher on the Modified Scale for Suicide Ideation - Self Report (Clum \& Yang, 1995)
Key exclusion criteria (16 listed)
- Current manic or hypomanic symptoms, as assessed by the Diagnostic Assessment Research Tool (DART) screener and diagnostic modules, where relevant.
- Current clinically significant psychotic symptoms not better accounted for by BPD, as assessed by the DART psychotic symptoms screener.
- Current alcohol or substance use disorder, that in the opinion of a study PIs, is of sufficient severity to impede engagement in treatment or is associated with significant risk of medical withdrawal, as assessed by the DART.
- Medical documentation or self-report of current anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified - atypical anorexia nervosa or atypical bulimia nervosa, that is in the opinion of a study PIs is of sufficient severity to be associated with significant medical risks
- Acute suicide risk, sufficient to require immediate hospitalization;
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 |
|---|---|---|
| TMSAlso: iTBSTMS 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. | Device | TMS + D-cycloserine |
| D-Cycloserine (DCS)Participants will be asked to take a single dose (250mg) of D-cycloserine the night before the treatment day. | Drug | TMS + D-cycloserine |
Primary outcome
Acceptability of Intervention Measure (AIM)
Time frame: Week 5
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.
Motor-evoked potentials (MEPs)
Time frame: Within 10 minutes pre- and 5 minutes post- treatment sessions 1,2,10,and final session
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.
7 secondary outcomes
Modified Scale for Suicide Ideation - Self Report (MSSI-SR)
Time frame: 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)
Time frame: 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)
Time frame: From baseline through to week 11. Taken at week 1, week 7, and week 11
The Brief Version of the Mentalization Scale (MentS-12)
Time frame: From baseline through to week 11. Taken at week 1, week 7, and week 11
Social Safeness and Pleasure Scale (SSPS)
Time frame: From baseline through to week 11. Taken at week 1, week 7, and week 11
Borderline Symptom List 23 (BSL-23)
Time frame: From baseline through to week 11. Taken at week 1, week 7, and week 11
Patient Health Questionnaire 9 (PHQ-9)
Time frame: From baseline through to week 11. Taken at week 1, week 7, and week 11
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No. 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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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.
Jenna M Traynor, PhD principal investigator
Mclean Hospital
Joshua Brown, MD, PhD principal investigator
Mclean Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TMS and D-Cycloserine (DCS) in people with Borderline Personality Disorder (BPD), run by Mclean Hospital 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 3 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Velev, BA (617-855-3430, avelev@mclean.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM) (time frame: Week 5). The study lists 2 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 5 Aug 2026.