An Early Phase 1 interventional study of methylphenidate and matched placebo tablet in Borderline Personality Disorder, sponsored by Tanta University. Not yet recruiting. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-06.
Sponsored by Tanta University · Early Phase 1, Interventional, and Health services research
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.
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).
277 studies on the registry are indexed under Borderline Personality Disorder; 68 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 222 interventional studies indexed under Borderline Personality Disorder.
Browse Borderline Personality Disorder studies →Tanta University is the lead sponsor of 991 studies on the registry; 316 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Individuals aged 18-50 years.
Exclusion Criteria:
Diagnosed with ADHD or other neurodevelopmental disorders where Concerta is typically prescribed.
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
Participants in the placebo group will receive a matched placebo tablet
Drug: matched placebo tablet
patient group will recieve methylphenidate
Also known as: Concerta
placebo gtoup will recieve matched placebo tablet
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)
Time frame: 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)
Time frame: 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
Time frame: 3 months
No study locations are listed for this record.
Start is estimated for Jan 2025; primary completion for Mar 2025, 2 months later.
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This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methylphenidate
Borderline Personality Disorder →