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Набор скоро начнётся NCT06759298

The Effects of Methylphenidate on Symptomatology in Individuals With Borderline Personality Disorder

Ранняя фаза I С лечением Borderline Personality Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: methylphenidate, matched placebo tablet.
Кому может быть актуально
Состояния в реестре: Borderline Personality Disorder. Базовые параметры: 18 лет — 50 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This study aims to investigate the effects of methylphenidate on symptomatology in individuals with borderline personality disorder. Specifically, it will evaluate whether Concerta is effective in reducing impulsivity, mood instability, and inattention among patients with BPD. Additionally, the study will assess Concerta's safety profile in this population to determine its potential as a supportive pharmacological option in BPD management.

Подробное описание

Borderline personality disorder (BPD) is a complex mental health condition characterized by pervasive instability in mood, self-image, interpersonal relationships, and behavior.

Individuals with BPD often experience intense episodes of anger, depression, and anxiety, which can lead to impulsive behaviors, self-harm, and strained social relationships. These symptoms significantly impair daily functioning and quality of life(American Psychiatric Association, 2013). creating a substantial burden on individuals and healthcare systems(Lieb et al., 2004).

. While psychotherapy remains the primary treatment for BPD, pharmacological interventions are often utilized to address specific symptoms, such as mood instability, impulsivity, and inattention.

Traditional medications like antidepressants, antipsychotics, and mood stabilizers have shown varying levels of efficacy in treating BPD, but no medication is currently approved specifically for BPD treatment(Chapman, 2019).. As a result, there is a growing interest in exploring alternative pharmacological options that may alleviate specific symptom clusters within BPD (Fleischhaker et al., 2011).

methylphenidate, a long-acting formulation of methylphenidate commonly prescribed for attention-deficit/hyperactivity disorder (ADHD), has shown promising effects on attention, impulsivity, and mood regulation(Hirsch \& Hauschild, 2019).

These effects suggest it may be beneficial in managing certain BPD symptoms, particularly impulsivity and mood dysregulation. Preliminary studies have indicated that stimulant medications like methylphenidate may help some individuals with BPD improve focus and control impulsive behaviors, but comprehensive research on methylphenidate's efficacy and safety in this population remains limited(Wilens, Morrison, \& Prince, 2011).

Вмешательства

  • Препарат methylphenidate
    patient group will recieve methylphenidate
  • Препарат matched placebo tablet
    placebo gtoup will recieve matched placebo tablet

Первичные конечные точки

  • Reduction in impulsivity and mood instability as measured by Barratt Impulsiveness Scale-11 (Revised) [Срок оценки: 3 months]
  • reduction of depression symptoms in borderline personality as meassured by as measured by Barratt Impulsiveness Scale-11 (Revised) [Срок оценки: 3 months]
  • Reduction in Perceived Stress in borderline as meassured by Perceived Stress Scale AScale [Срок оценки: 3 months]

Критерии участия

Критерии включения

  • • Individuals aged 18-50 years.
  • Diagnosed with borderline personality disorder as confirmed by a structured clinical interview.
  • Experiencing at least moderate levels of impulsivity and mood instability.
  • Not currently receiving stimulant medication or any pharmacotherapy specifically contraindicated with methylphenidate.
  • Capable of providing informed consent.

Критерии исключения

  • • Diagnosed with ADHD or other neurodevelopmental disorders where Concerta is typically prescribed.
  • Severe co-morbid psychiatric disorders (e.g., schizophrenia, bipolar disorder) or substance use disorder.
  • Known hypersensitivity to methylphenidate or other stimulant medications.
  • Pregnant or lactating women.
  • Individuals currently undergoing intensive psychotherapy or those unwilling to discontinue existing psychotropic medications that may interact with Concerta.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Lieb K, Zanarini MC, Schmahl C, Linehan MM, Bohus M. Borderline personality disorder. Lancet. 2004 Jul 31-Aug 6;364(9432):453-61. doi: 10.1016/S0140-6736(04)16770-6. PMID 15288745

Идентификаторы

NCT: NCT06759298 · methylphenidate in borderline

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗