NCT07460947招募中1 期
A Pilot Trial of One Day Accelerated Intermittent Theta-burst Stimulation Plus D-cycloserine in Suicidal Patients With Borderline Personality Disorder (ONE-D BPD)
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Acceptability of Intervention Measure (AIM)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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;
- •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
研究组 & 干预措施
TMS + D-cycloserine
Experimental
Open-label combination of TMS and D-cycloserine
干预措施: TMS (Device)
TMS + D-cycloserine
Experimental
Open-label combination of TMS and D-cycloserine
干预措施: D-Cycloserine (DCS) (Drug)
结局指标
主要结局
Acceptability of Intervention Measure (AIM)
时间窗: 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)
时间窗: 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.
次要结局
- Modified Scale for Suicide Ideation - Self Report (MSSI-SR)(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)(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)(From baseline through to week 11. Taken at week 1, week 7, and week 11)
- The Brief Version of the Mentalization Scale (MentS-12)(From baseline through to week 11. Taken at week 1, week 7, and week 11)
- Social Safeness and Pleasure Scale (SSPS)(From baseline through to week 11. Taken at week 1, week 7, and week 11)
- Borderline Symptom List 23 (BSL-23)(From baseline through to week 11. Taken at week 1, week 7, and week 11)
- Patient Health Questionnaire 9 (PHQ-9)(From baseline through to week 11. Taken at week 1, week 7, and week 11)
研究者
Jenna M. Traynor
Prinicipal Investigator
Mclean Hospital
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Pilot Study for the Evaluation of a New Psychotherapeutic Treatment for Borderline Personality Disorder Patients With Post-traumatic Stress SymptomsNCT07305155Eva Rüfenacht40
招募中
不适用
Dialectical behavior therapy for Borderline Personality DisorderCTRI/2024/01/061602UGC JRF Scholarship 495(NET-JULY 2018) University Grants Commission30
已完成
不适用
The Effectiveness of Dialectical Behavioral Group Psychotherapy Compared to Supportive Individual Psychotherapy In Patients With Borderline Personality Disorder: A Study on Therapeutic Alliance, Depression, Cognitive Function, Impulsivity, Suicide Risk, BDNF Levels, NFkB Levels, SOD LevelsNCT07449104Natalia Dewi Wardani, MD66
尚未招募
3 期
A single blind randomised controlled trial comparing the efficacy and safety of low dose cariprazine vs olanzapine-fluoxitine combination in patients with bipolar depression-IICTRI/2024/10/074624Government medical college Patiala Punjab140
尚未招募
不适用
A 2-Part Study to Assess Efficacy, Safety and Tolerability of BMB-101 for the Treatment of Patients With Prader-Willi Syndrome.NCT07266324Bright Minds Biosciences Pty Ltd16