Caplyta for Borderline Personality Disorder
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Chicago
Must not be taking: New psychotropics
Disqualifiers: Schizophrenia, Bipolar I, Substance use, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?The primary objective of the proposed study is to evaluate the safety and efficacy of Caplyta (lumateperone) in adults with borderline personality disorder (BPD). Sixty subjects with BPD will be randomized in a 1:1 fashion to either Caplyta (42mg/day) or matching placebo for 8 weeks of active treatment. The hypothesis to be tested is that Caplyta will result in greater rates of reduction in symptoms of BPD compared to placebo (improvement in symptoms will be indicated by lower scores on established outcome measures of BPD symptoms that have been used in prior studies).
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot start any new psychotropic medications within 3 months before the study begins.
How does the drug Caplyta differ from other drugs for borderline personality disorder?
Caplyta is unique because it is an atypical antipsychotic that has been primarily used for treating schizophrenia and bipolar depression, and its use for borderline personality disorder is novel. Unlike other treatments that focus on mood stabilization or antidepressant effects, Caplyta may offer a different mechanism of action by targeting both dopamine and serotonin receptors, which could address a broader range of symptoms in borderline personality disorder.
12345Eligibility Criteria
This trial is for adults aged 18-65 in the Chicagoland area who have been diagnosed with Borderline Personality Disorder (BPD). Participants must be able to understand and sign a consent form.Inclusion Criteria
You have been diagnosed with BPD as your main medical condition.
You understand the information provided in the consent form and can sign it.
You are between 18 and 65 years old, regardless of gender.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either Caplyta (42mg/day) or placebo for 8 weeks
8 weeks
5 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests Caplyta (lumateperone) at 42mg/day against a placebo over an 8-week period. The goal is to see if Caplyta can better reduce BPD symptoms compared to the placebo, as measured by established outcome measures.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CaplytaExperimental Treatment1 Intervention
All subjects who are randomized to Caplyta will receive 42mg/day starting the first week of the study. Subjects will be seen every two weeks for 8 weeks. Dosage changes and reductions will not be permitted. After study conclusion (week 8), the dose will be discontinued.
Group II: PlaceboPlacebo Group1 Intervention
All subjects who are randomized to Placebo will receive an identical placebo pill to the experimental drug starting the first week of the study. Subjects will be seen every two weeks for 8 weeks. After study conclusion (week 8), the dose will be discontinued.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Chicago Medical CenterChicago, IL
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Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
Intra-Cellular Therapies, Inc.Industry Sponsor
References
The successful pharmacological treatment of adolescents and young adults with borderline personality disorder: a preliminary open trial of flupenthixol. [2018]Borderline personality disorder is a significantly disabling disturbance often arising in adolescents or young adults. In the absence of demonstrated effective treatments in this population, this open prospective study evaluated the effect of low dose (3 mg per day) flupenthixol in 13 rigorously diagnosed adolescents with borderline personality disorder. Therapeutic outcome over eight weeks of treatment assessed across measures of impulsivity, depression/dysphoria, general psychopathology and global functioning showed significant improvement in all spheres. These findings suggest that low dose flupenthixol may have a role to play in the short-term treatment of this population.
Pharmacotherapy of borderline personality disorder. Alprazolam, carbamazepine, trifluoperazine, and tranylcypromine. [2022]Sixteen female outpatients with borderline personality disorder and prominent behavioral dyscontrol, but without a current episode of major depression, were studied in a double-blind, crossover trial of placebo and the following four active medications: alprazolam (average dose, 4.7 mg/d); carbamazepine (average dose, 820 mg/d); trifluoperazine hydrochloride (average dose, 7.8 mg/d); and tranylcypromine sulfate (average dose, 40 mg/d). Each trial was designed to last six weeks. Tranylcypromine and carbamazepine trials had the highest completion rates. Physicians rated patients as significantly improved relative to placebo while receiving tranylcypromine and carbamazepine. Patients rated themselves as significantly improved relative to placebo only while receiving tranylcypromine. Patients who tolerated a full trial of trifluoperazine showed improvement, those receiving carbamazepine demonstrated a marked decrease in the severity of behavioral dyscontrol, and those receiving alprazolam had an increase in the severity of the episodes of serious dyscontrol. As an adjunct to psychotherapy, pharmacotherapy can produce modest but clinically important improvement in the mood and behavior of patients with borderline personality disorder. As a research tool, patterns of pharmacological response may provide clues to biological mechanisms underlying dysphoria and behavioral dyscontrol.
Pharmacological interventions for borderline personality disorder. [2022]Drugs are widely used in borderline personality disorder (BPD) treatment, chosen because of properties known from other psychiatric disorders ("off-label use"), mostly targeting affective or impulsive symptom clusters.
Update on pharmacotherapy of borderline personality disorder. [2019]Pharmacotherapy is a very common form of treatment for borderline personality disorder or its concomitant disorders. This paper reviews all the open-label and placebo-controlled trials of second generation medications studied in samples of well-defined borderline patients. Most of the medications studied in double-blind, placebo-controlled trials were efficacious. Most of these medications were also useful in treating symptoms of affective dysregulation and impulsive aggression, which have been suggested to be the core dimensions of psychopathology of underlying borderline personality disorder. Taken together, the results of these studies suggest that the choice of medication can be guided as much by tolerability and safety as by symptom presentation. It also suggests that the common practice of polypharmacy, which has no empiric support, may be unnecessary for most patients with borderline personality disorder.
Efficacy and tolerability of pharmacotherapies for borderline personality disorder. [2021]Borderline personality disorder is a pervasive pattern of instability of interpersonal relationships, affects and self-image, as well as marked impulsivity. Although psychotherapy is needed to attain lasting improvements in a patient's personality and overall functioning, practice guidelines state that pharmacotherapy is indicated to manage state symptoms and trait vulnerabilities. Three psychopathological dimensions are the main targets for pharmacotherapy of borderline personality disorder: affective dysregulation, impulsive-behavioural dyscontrol and cognitive-perceptual symptoms. Guidelines recommend the use of antidepressant agents and mood stabilizers for affective dysregulation and impulsive-behavioural dyscontrol, and antipsychotics for cognitive-perceptual symptoms. This review aims to report and discuss data from clinical trials, reviews and meta-analyses concerning drug efficacy and tolerability in the treatment of borderline personality disorder. Investigations that considered antidepressant agents mainly focused on SSRIs, which are recommended as first-line treatments for affective instability and impulse dyscontrol. Both open-label and randomized controlled studies have been performed, predominantly concerning the efficacy of fluoxetine and fluvoxamine. Other classes of antidepressants, such as TCAs and MAOIs, were investigated as alternative treatments for borderline personality disorder, but the risk of adverse effects and toxicity is a limitation to their use in clinical practice. Increasing amounts of data have recently been collected on the use of mood stabilizers to control mood instability and impulsivity in patients with borderline personality disorder. More substantial data were derived from controlled trials of valproate semisodium, although other drugs such as lithium, carbamazepine, oxcarbazepine and lamotrigine were tested with promising results. Several first-generation antipsychotics were studied in open-label and controlled trials, with good effects on behavioural dyscontrol and psychotic-like symptoms. Selection biases and heterogeneity of drugs and methods somewhat limited the value of these results. More recent investigations have examined atypical antipsychotics, with most of these studies being open-label trials with small sample sizes; however, a few controlled studies have been performed using olanzapine, showing improvements in impulsivity, anger and hostility. In conclusion, a large number of different drugs have been evaluated in the treatment of patients with borderline personality disorder. Initial findings are encouraging for many of these drugs. However, data need to be replicated in further controlled studies with head-to-head comparisons and long-term follow-ups. Many questions remain to be answered.