NCT06759298

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Jan 2025

Shorter than P25 for early_phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2024

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 6, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

January 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
Last Updated

January 6, 2025

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

December 10, 2024

Last Update Submit

December 28, 2024

Conditions

Borderline Personality Disorder

Keywords

methylphenidate

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Concerta Group

ACTIVE COMPARATOR

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

Placebo Group

PLACEBO COMPARATOR

Participants in the placebo group will receive a matched placebo tablet

Drug: matched placebo tablet

Interventions

methylphenidateDRUG

patient group will recieve methylphenidate

Also known as: Concerta
Concerta Group
matched placebo tabletDRUG

placebo gtoup will recieve matched placebo tablet

Placebo Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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: 15288745BACKGROUND

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Osama Ibrahim Younes

CONTACT

01024188789osamaebrahim2012@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of psychiatry

Study Record Dates

First Submitted

December 10, 2024

First Posted

January 6, 2025

Study Start

January 15, 2025

Primary Completion

March 25, 2025

Study Completion

March 25, 2025

Last Updated

January 6, 2025

Record last verified: 2024-12