Borderline Personality DisorderPhase 3NCT01912391
Clinical Research Study to Evaluate Selegiline in the Treatment of Borderline Personality Disorder
A Phase 3 study testing Selegiline in people with Borderline Personality Disorder, run by Mood and Anxiety Research, Inc at 1 site in United States.
Trial summary
Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline Personality Disorder
- What is being tested?
- Selegiline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Mar 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject has primary diagnosis of Borderline Personality Disorder(BPD).
- Subject has Symptomatology of BPD for at least 1 year.
- Subject understands the study procedures and voluntarily agree to participate.
- Subject is able to read, understand and complete questionnaires.
- Subject agrees to use (2)acceptable forms of contraception throughout the study.
- Patient must have a screening SCL 90-R score of > 120 (range 0-360).
Who cannot join
- Subject is not pregnant or breast feeding.
- Subject is unlikely to adhere to the study procedures and restrictions.
- Patient has failed treatment due to lack of efficacy of monoamine oxidase inhibitor(MAOI) medication.
- Patient anticipates need for surgery during the study.
- Patient has another predominant personality disorder other than BPD.
- Subject has an active history of substance abuse or dependence, e.g.,Positive Drug screen
Show all 14Show fewer
- Subject has other health issues which could interfere with study interpretation.
- Subject reports recent suicide attempts or homicide attempts in the past 3 months.
- Subject must be substance abuse or dependence clean for (1) year.
- Subject has a history of a primary malignancy < 5 yrs.
- Subject has a medical condition(s)that are excluded, per Protocol, or are unstable.
- Subject has abnormal screening laboratory values, per Protocol, or other clinically significant, unexplained laboratory abnormality.
- Subject is currently participating or has participated in a study within 30 days.
- Patient has donated blood products or has had phlebotomy of > 300 ml within 8 weeks.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mood and Anxiety Research, Inc
Fresno, California, 93720
About this study
Official title: A Phase III Randomized Double-blind, 12 Week, Placebo Controlled Trial of Transdermal Selegiline in Borderline Personality Disorder (BPD) to Evaluate Efficacy and Safety
Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder.
Read the detailed description
Borderline Personality Disorder (BPD) is a chronic disorder occurring in 2-3% of the population. BPD is accompanied by high levels of co-existing psychiatric and physical disorders. One key predictor is persistent and recurring major depressive disorder.
Since BPD is most closely linked with mood disorders and depression in particular, the use of antidepressant medications to treat the disorder is logical. However, to date, there are no FDA approved treatments for BPD. The American Psychiatric Association's Treatment Guidelines for Borderline Personality Disorder recommend antidepressants as a primary treatment of the disorder.
Earlier trials using antidepressants that increase certain brain chemicals, such as, serotonin and noradrenalin have shown efficacy in controlling the mood swings of the illness for many people. These studies also document efficacy in controlling physical disorders, including headaches, migraines, irritable bowel, neurodermatitis (skin rash), fibromyalgia, premenstrual syndrome, and tempomandibular joint dysfunction (TMJ).
group of antidepressants known as monoamine oxidase inhibitors (MAOIs) have also been shown to be effective in BPD patients. The oral form of these medications was accompanied by dietary restrictions, potential drug interactions, blood pressure changes and weight gain.
Selegiline, a MAOI antidepressant, was put into a skin patch delivery system (transdermal) that reduced the side-effect profile. Trials without placebo control showed many individuals with BPD benefit from the selegiline skin patch. This trial will look at individuals on the selegiline and placebo to make sure the selegiline is or is not effective in treating BPD.
- Conditions
- Borderline Personality Disorder
- Being tested
- Selegiline, Placebo (for Selegiline)
- Keywords
- Depression, Anxiety, Headaches, Migraines, Irritable Bowel Syndrome IBS, Neurodermatitis, Fibromyalgia, Premenstrual Syndrome PMS, Temporomandibular Joint Dysfunction TMJ
- Medical subject headings
- Borderline Personality Disorder, Depression, Anxiety Disorders, Headache, Migraine Disorders, Irritable Bowel Syndrome, Neurodermatitis, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SelegilineDrug
Also called Emsam
The Study Drug known as either selegiline 12 mg patch or matching placebo patch will be administered daily beginning at Visit 2 for the duration of 12 weeks.
Placebo (for Selegiline)Drug
Transdermal Placebo patch manufactured to mimic Transdermal Selegiline 12 mg. patch
| Study group | Role | What they receive |
|---|---|---|
| Selegiline | Experimental | Transdermal Selegiline 12 mg patch Apply (1) patch daily Receives: Drug: Selegiline |
| Placebo (for Selegiline) | Placebo comparator | Transdermal Placebo patch Apply (1) patch daily Receives: Drug: Placebo (for Selegiline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale
The study subject will complete the SCL 90-R questionnaire at each visit on arrival at the office prior to meeting with the research staff. This will serve as the primary efficacy measure of outcome for the study. This instrument has been utilized in clinical trials since the early 1960s, and has a good ability to measure overall levels of psychological and physical functioning in this patient group.
Measured: Weeks 1-12
Secondary outcomes (4)
Secondary Efficacy Measurement: Change in Hamilton Depression Inventory 17 Questions (HAM-D)
Clinician will administer the HAM-D scale to subject at each visit to assess any changes in their overall symptoms, functioning social and daily life.
Measured: Weeks 1 - 12
Clinical Global Impression of Change- Clinician (CGIc)
Clinician will assess any improvement in their overall symptoms, functioning social and daily life beginning at week 3(Visit 3)through week 12 (Visit 6).
Measured: Weeks 3-12
Clinical Global Impression Change- Patient (CGIp)
Patient will assess any improvement in their overall symptoms, functioning social and daily life beginning at week 3(Visit 3)through week 12 (Visit 6).
Measured: Weeks 3 -12
Sheehan Disability Scale (SDS)
Patient will assess any improvement in their overall functioning in their work / school, social and daily life at 3 time points
Measured: Weeks 1, 4, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startOct 2012
- Primary completionMar 2015
- Study completionMar 2015
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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mood and Anxiety Research, Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul J Markovitz, MD, PhD, Study director, Mood and Anxiety Research, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912391
- Sponsor's protocol ID
- PJM-01
- Other IDs
- WV26504-4245
- Status last verified
- Oct 2015
- First submitted
- 16 Jul 2013
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
PubMed 36375174
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Double-blind, 12 Week, Placebo Controlled Trial of Transdermal Selegiline in Borderline Personality Disorder (BPD) to Evaluate Efficacy and Safety
- ClinicalTrials.gov ID
- NCT01912391
- Acronym / sponsor ID
- PJM-01
- Conditions
- Borderline Personality Disorder
- Keywords
- Depression, Anxiety, Headaches, Migraines, Irritable Bowel Syndrome IBS, Neurodermatitis, Fibromyalgia, Premenstrual Syndrome PMS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mood and Anxiety Research, IncUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 31 Jul 2013 (estimated)
- 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.
Selegiline is superior to placebo in improving psychological and physical functioning in patients with Borderline Personality Disorder.
Detailed description
Borderline Personality Disorder (BPD) is a chronic disorder occurring in 2-3% of the population. BPD is accompanied by high levels of co-existing psychiatric and physical disorders. One key predictor is persistent and recurring major depressive disorder.
Since BPD is most closely linked with mood disorders and depression in particular, the use of antidepressant medications to treat the disorder is logical. However, to date, there are no FDA approved treatments for BPD. The American Psychiatric Association's Treatment Guidelines for Borderline Personality Disorder recommend antidepressants as a primary treatment of the disorder.
Earlier trials using antidepressants that increase certain brain chemicals, such as, serotonin and noradrenalin have shown efficacy in controlling the mood swings of the illness for many people. These studies also document efficacy in controlling physical disorders, including headaches, migraines, irritable bowel, neurodermatitis (skin rash), fibromyalgia, premenstrual syndrome, and tempomandibular joint dysfunction (TMJ).
group of antidepressants known as monoamine oxidase inhibitors (MAOIs) have also been shown to be effective in BPD patients. The oral form of these medications was accompanied by dietary restrictions, potential drug interactions, blood pressure changes and weight gain.
Selegiline, a MAOI antidepressant, was put into a skin patch delivery system (transdermal) that reduced the side-effect profile. Trials without placebo control showed many individuals with BPD benefit from the selegiline skin patch. This trial will look at individuals on the selegiline and placebo to make sure the selegiline is or is not effective in treating BPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selegiline | Experimental | Drug: SelegilineTransdermal Selegiline 12 mg patch Apply (1) patch daily |
| Placebo (for Selegiline) | Placebo comparator | Drug: Placebo (for Selegiline)Transdermal Placebo patch Apply (1) patch daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has primary diagnosis of Borderline Personality Disorder(BPD).
- Subject has Symptomatology of BPD for at least 1 year.
- Subject understands the study procedures and voluntarily agree to participate.
- Subject is able to read, understand and complete questionnaires.
- Subject agrees to use (2)acceptable forms of contraception throughout the study.
Key exclusion criteria (14 listed)
- Subject is not pregnant or breast feeding.
- Subject is unlikely to adhere to the study procedures and restrictions.
- Patient has failed treatment due to lack of efficacy of monoamine oxidase inhibitor(MAOI) medication.
- Patient anticipates need for surgery during the study.
- Patient has another predominant personality disorder other than BPD.
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 |
|---|---|---|
| SelegilineAlso: EmsamThe Study Drug known as either selegiline 12 mg patch or matching placebo patch will be administered daily beginning at Visit 2 for the duration of 12 weeks. | Drug | Selegiline |
| Placebo (for Selegiline)Transdermal Placebo patch manufactured to mimic Transdermal Selegiline 12 mg. patch | Drug | Placebo (for Selegiline) |
Primary outcome
Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale
Time frame: Weeks 1-12
The study subject will complete the SCL 90-R questionnaire at each visit on arrival at the office prior to meeting with the research staff. This will serve as the primary efficacy measure of outcome for the study. This instrument has been utilized in clinical trials since the early 1960s, and has a good ability to measure overall levels of psychological and physical functioning in this patient group.
4 secondary outcomes
Secondary Efficacy Measurement: Change in Hamilton Depression Inventory 17 Questions (HAM-D)
Time frame: Weeks 1 - 12
Clinical Global Impression of Change- Clinician (CGIc)
Time frame: Weeks 3-12
Clinical Global Impression Change- Patient (CGIp)
Time frame: Weeks 3 -12
Sheehan Disability Scale (SDS)
Time frame: Weeks 1, 4, 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
- Derived from this study: PubMed 36375174Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
Related trials for Borderline Personality Disorder
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Ketamine Infusion for Symptomatic Improvement in Severe Borderline Personality Disorder
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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. This study is not recruiting at the moment.
Paul J Markovitz, MD, PhD study director
Mood and Anxiety Research, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Selegiline in people with Borderline Personality Disorder, run by Mood and Anxiety Research, Inc at 1 site in United States.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Measurement: Changes in the Hopkins Symptom Checklist 90-Revised (SCL 90-R) scale (time frame: Weeks 1-12). 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 NCT01912391, 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 8 Oct 2015.