Borderline Personality DisorderEarly Phase 1NCT06759298
The Effects of Methylphenidate on Symptomatology in Individuals With Borderline Personality Disorder
A Early Phase 1 study testing methylphenidate in people with Borderline Personality Disorder, run by Tanta University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2025to 25 Mar 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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).
- Conditions
- Borderline Personality Disorder
- Being tested
- methylphenidate, matched placebo tablet
- Keywords
- methylphenidate
- Medical subject headings
- Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidateDrug
Also called Concerta
patient group will recieve methylphenidate
matched placebo tabletDrug
placebo gtoup will recieve matched placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: methylphenidate |
| Placebo Group | Placebo comparator | Participants in the placebo group will receive a matched placebo tablet Receives: Drug: matched placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion25 Mar 2025 (estimated)
- Study completion25 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Borderline Personality DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Ibrahim Younes, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06759298
- Sponsor's protocol ID
- methylphenidate in borderline
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 6 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 15288745
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Methylphenidate on Symptomatology in Individuals With Borderline Personality Disorder
- ClinicalTrials.gov ID
- NCT06759298
- Acronym / sponsor ID
- methylphenidate in borderline
- Conditions
- Borderline Personality Disorder
- Keywords
- methylphenidate
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 25 Mar 2025 (estimated)
- Study completion
- 25 Mar 2025 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concerta Group | Active comparator | Drug: methylphenidateParticipants 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 |
| Placebo Group | Placebo comparator | Drug: matched placebo tabletParticipants in the placebo group will receive a matched placebo tablet |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • Individuals aged 18-50 years.
Key exclusion criteria (5 listed)
- • Diagnosed with ADHD or other neurodevelopmental disorders where Concerta is typically prescribed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylphenidateAlso: Concertapatient group will recieve methylphenidate | Drug | Concerta Group |
| matched placebo tabletplacebo gtoup will recieve matched placebo tablet | Drug | Placebo Group |
Primary outcome
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)
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Background: PubMed 15288745Lieb 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing methylphenidate in people with Borderline Personality Disorder, run by Tanta University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Osama Ibrahim Younes (01024188789, osamaebrahim2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in impulsivity and mood instability as measured by Barratt Impulsiveness Scale-11 (Revised) (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06759298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.