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NCT Number: NCT06759298

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • 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.

Exclusion criteria

  • • 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.

Treatment and study plan

Methylphenidate

Drug

patient group will recieve methylphenidate

Other names: Concerta

matched placebo tablet

Drug

placebo gtoup will recieve matched placebo tablet

Primary outcomes

  1. Reduction in impulsivity and mood instability as measured by Barratt Impulsiveness Scale-11 (Revised)

    Time frame: 3 months

    Reduction in impulsivity and mood instability in borderline as measured by Barratt Impulsiveness Scale-11 (Revised)

  2. reduction of depression symptoms in borderline personality as meassured by as measured by Barratt Impulsiveness Scale-11 (Revised)

    Time frame: 3 months

    reduction of depression symptoms in borderline personality as meassured by as measured by Barratt Impulsiveness Scale-11 (Revised)

  3. Reduction in Perceived Stress in borderline as meassured by Perceived Stress Scale AScale

    Time frame: 3 months

    Reduction in Perceived Stress in borderline as meassured by Perceived Stress Scale

Study contacts

Contact information is provided by the study sponsor or research team.

Osama Ibrahim Younes

CONTACT

[email protected]

01024188789

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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