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.

Study Overview

• Status: Not yet recruiting
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Drug: methylphenidate; Drug: matched placebo tablet

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).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Osama Ibrahim Younes; Phone Number: 01024188789; Email: osamaebrahim2012@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Concerta Group; Participants will receive a starting dose of Concerta (18 mg/day), which may be titrated based on clinical response and tolerance, up to a maximum of 54 mg/day. tablet form once daily for 3 months	Drug: methylphenidate; patient group will recieve methylphenidate; Other Names: Concerta
Placebo Comparator: Placebo Group; Participants in the placebo group will receive a matched placebo tablet	Drug: matched placebo tablet; placebo gtoup will recieve matched placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in impulsivity and mood instability as measured by Barratt Impulsiveness Scale-11 (Revised)	Reduction in impulsivity and mood instability in borderline as measured by Barratt Impulsiveness Scale-11 (Revised)	3 months
reduction of depression symptoms in borderline personality as meassured by as measured by Barratt Impulsiveness Scale-11 (Revised)	reduction of depression symptoms in borderline personality as meassured by as measured by Barratt Impulsiveness Scale-11 (Revised)	3 months
Reduction in Perceived Stress in borderline as meassured by Perceived Stress Scale AScale	Reduction in Perceived Stress in borderline as meassured by Perceived Stress Scale	3 months

Collaborators and Investigators

• Sponsor: Tanta University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): March 25, 2025
• Study Completion (Estimated): March 25, 2025

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 28, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 28, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: methylphenidate
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Central Nervous System Stimulants; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Dopamine Agents; Methylphenidate
• Other Study ID Numbers: methylphenidate in borderline

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No