A Novel Drug for Borderline Personality Disorder

Launched by THE ALFRED · Mar 26, 2014

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication for people with Borderline Personality Disorder (BPD), a serious mental health condition that affects emotions and relationships. BPD can cause intense mood swings, impulsive actions, and difficulties in maintaining stable relationships. Unfortunately, there are currently no specific medications that effectively treat BPD, and many patients struggle with existing treatment options. The trial is looking to see if a drug, which has been approved for Alzheimer’s disease and has shown promise in treating other psychiatric conditions, can help patients with BPD when added to their current treatment.

To participate in the study, individuals aged 18 to 65 who have been diagnosed with BPD may be eligible, provided they meet certain criteria. Participants will be randomly assigned to receive either the trial medication or a placebo (a non-active pill) for 12 weeks. Throughout the trial, researchers will assess how well the medication works by monitoring changes in symptoms. It's important for potential participants to know that they should not start any new therapy or medications during the trial period and that certain medical conditions or medications may exclude them from joining.

Gender

ALL

Eligibility criteria

• • Inclusion criteria
• Participants will be eligible to proceed in the study if they meet all of the following criteria (as determined in the screening session):
• • 1. Men and women aged between 18-65 years of age
• • 2. A diagnosis of BPD according to the Diagnostic Interview for Borderline patients or the Zanarini Rating Scale for Borderline Personality Disorder
• • 3. Proficient in reading and writing English
• • Exclusion criteria
• Potential participants who meet the criteria for any of the following will be excluded from participating in the study:
• • 1. Clinical evidence of CNS pathology, neurological disorder, head injury, epileptic seizures or convulsions.
• • 2. Currently pregnant or breastfeeding
• • 3. A current DSM-IV-TR diagnosis of substance abuse or dependence disorder, or another Axis I disorder including a past or current diagnosis of schizophrenia, delusional (paranoid) disorder, schizoaffective disorder, bipolar I (mixed, manic, depressed or euthymic) or psychotic depression. Individuals with bipolar II will be included
• • 4. Clinically significant and active evidence of liver or kidney disease, hematological, respiratory, endocrine or cardiovascular disease.
• • 5. Use of prescription drugs that may cause relevant drug interactions with the study drug according to the summary of product characteristics: NMDAR antagonists (amantadine, ketamine, dextromethorphan), L-Dopa, dopamine agonists and cholinergic agonists.
• • 6. Commencing new psychotherapy/ new medication during the trial period.
• • 7. History of mental retardation or documented IQ below 75