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Not yet recruiting NCT06759298

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

Early Phase I Interventional Borderline Personality Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: methylphenidate, matched placebo tablet.
Who it may be relevant to
Registry conditions: Borderline Personality Disorder. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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).

Interventions

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

Primary outcome measures

  • Reduction in impulsivity and mood instability 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) [Time frame: 3 months]
  • Reduction in Perceived Stress in borderline as meassured by Perceived Stress Scale AScale [Time frame: 3 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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

Identifiers

NCT: NCT06759298 · methylphenidate in borderline

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗