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| Name | Class |
|---|---|
| Intra-Cellular Therapies, Inc. | INDUSTRY |
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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).
Borderline personality disorder (BPD) is a serious, difficult to treat, psychiatric disorder that causes significant emotional distress, as well as resulting in significant economic burden to health care systems. A variety of psychotherapies, particularly dialectical behavior therapy (DBT) and systems training for emotional predictability and problem solving (STEPPS), have shown benefit in reducing many of the core symptoms of BPD. Healthcare systems, however, often lack the funding and appropriate expertise to implement these treatments, and finding trained DBT or STEPPS therapists has been difficult for many people with BPD. While research on the use of medication is ongoing, no drug has yet been approved in the United States or elsewhere for the treatment of BPD. Antidepressants, anti-convulsants, and second generation antipsychotics have all been examined, but current medication options for BPD often provide only partial relief and may have pronounced side effects.
BPD is characterized by a pervasive pattern of severe psychopathological symptoms with instability of affect regulation, impulse control, and aggression. Dysfunctions in the serotoninergic, dopaminergic, and glutamatergic systems have been demonstrated in-and considered as possible causes for-symptoms associated with the disorder. Caplyta (lumateperone) therefore has distinctive properties that make it a promising option for patients with BPD. Caplyta is a mechanistically novel agent as it simultaneously modulates serotonin, dopamine, and glutamate, the key neurotransmitters implicated in BPD. Specifically, Caplyta acts as a potent serotonin 5-HT2A receptor antagonist, a dopamine D2 receptor pre-synaptic partial agonist and post-synaptic antagonist, a D1 receptor-dependent modulator of glutamate, and a serotonin reuptake inhibitor. In addition, because of low rates of side effects, Caplyta should be a well-tolerated and in fact desired medication approach to BPD.
The aim of the present study is to examine the efficacy and safety of Caplyta vs. placebo in adults with BPD, as indicated by a score of at least 9 on the Zanarini Rating Scale for Borderline Personality Disorder ("Zanarini scale"), a scale of illness severity, at the baseline visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 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. |
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| Caplyta | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caplyta | Drug | Atypical antipsychotic |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score | The ZAN-BPD is a clinician-administered scale assessing borderline personality disorder symptom severity (total scores range from 0-36). Higher scores indicate more severe symptoms. The ZAN-BPD will be administered at all 5 visits, but only the change from baseline to visit 5 at week 8 will be reported. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Modified Overt Aggression Scale (MOAS) Total Score | The MOAS is a clinician-administered behavior rating scale measuring four types of aggressive behavior. The MOAS will be administered at all 5 visits, but only the change from baseline to visit 5 at week 8 will be reported. The total weighted scores range from 0-40, with 0 indicating no aggression. Higher total scores indicate higher aggression levels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon E Grant, MD, JD, MPH | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medical Center | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 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. Placebo: Pill that contains no medicine. |
| FG001 | Caplyta | 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. Caplyta: Atypical antipsychotic |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 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. Placebo: Pill that contains no medicine. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score | The ZAN-BPD is a clinician-administered scale assessing borderline personality disorder symptom severity (total scores range from 0-36). Higher scores indicate more severe symptoms. The ZAN-BPD will be administered at all 5 visits, but only the change from baseline to visit 5 at week 8 will be reported. | The number of participants who completed the trial is less than the number of subjects who were enrolled. | Posted | Mean | Standard Deviation | Score on a scale | 8 weeks |
|
Adverse event data were collected from the Screening Visit to Visit 5 (8 weeks).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 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. Placebo: Pill that contains no medicine. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anorectal fissure | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jon E. Grant | University of Chicago | 7738341325 | jgrant4@bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 11, 2024 | Apr 1, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001883 | Borderline Personality Disorder |
| ID | Term |
|---|---|
| D010554 | Personality Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000705749 | lumateperone |
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| Placebo | Drug | Pill that contains no medicine. |
|
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| 8 weeks |
| Change in Young Mania Rating Scale (YMRS) Total Score | The YMRS is a clinician-administered, 11-item scale assessing manic symptoms at baseline and over time. The YMRS will be administered at all 5 visits, but only the change from baseline to visit 5 at week 8 will be reported. Higher total scores (ranging from 0-60) indicate higher severity of manic symptoms. This scale is used to rate the severity of manic abnormality in participants. | 8 weeks |
| Change in Zanarini Rating Scale for Borderline Personality Disorder Self-Report Version (ZAN-BPD-SRV) Total Score | The ZAN-BPD-SRV is a self-report scale assessing borderline personality severity that will be assessed at all 5 visits. However, only the change from baseline to visit 5 at week 8 will be reported. Scoring is done by counting the number of yes's. Total scores range from 0-36, with higher scores indicating more severe symptoms. A score of 8 or more is indicative of a diagnosis of borderline personality disorder. | 8 weeks |
| Change in Borderline Evaluation of Severity Over Time (BEST) Total Score | The BEST is a self-rated scale used to measure severity and change. The first 12 items of the scale are scored on a scale from 1-5, with 5 meaning that the item caused extreme distress, severe difficulties in relationships, and/or kept the participant from getting things done. The lowest rating (1) means it caused little or no problems. Items 13-15 (positive behaviors) are rated according to frequency. The BEST will be administered at all 5 visits, but only the change from baseline to visit 5 at week 8 will be reported. | 8 weeks |
| Change in Barratt Impulsiveness Scale (BIS-11) Total Score | This BIS-11 is a self-report assessment of impulsivity that will be assessed at baseline and Visit 5. The change from baseline to visit 5 at week 8 will be reported. All items are added to result in a total score ranging from 30-120. Higher total scores indicate higher impulsiveness. | 8 weeks |
| Minnesota Impulsive Disorders Interview (MIDI) | The MIDI is a clinical interview that screens for a variety of impulsive disorders, including buying disorder, kleptomania, trichotillomania, intermittent explosive disorder, pyromania, gambling disorder, compulsive sexual behavior, and binge eating disorder. | 8 weeks |
| Change in Hamilton Depression Rating Scale (HAM-D) Total Score | The HAM-D is a clinician-administered assessment of depression that will be assessed at all 5 study visits. However, only the change from baseline to visit 5 at week 8 will be reported. Higher total scores (ranging from 0-52) indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms. | 8 weeks |
| Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score | The HAM-A is a clinician-administered assessment of anxiety that will be assessed at all 5 study visits. However, only the change from baseline to visit 5 at week 8 will be reported. Higher total scores (ranging from 0-56) indicate higher levels of anxiety, with 0 being no symptoms of anxiety. | 8 weeks |
| Change in Quality of Life Inventory (QOLI) Total Weighted Satisfaction Score | The QOLI is a self-report assessment of patient perceived quality of life that will be assessed at baseline and visit 5. The change in total weighted satisfaction scores from baseline to visit 5 at week 8 will be reported. Higher scores (ranging from -96 to 96) indicate a higher quality of life, whereas lower scores indicate a lower quality of life. | 8 weeks |
| Change in Sheehan Disability Scale (SDS) Total Score | Subjects will complete the SDS at all 5 visits. The change in total scores (ranging from 0-30) from baseline to visit 5 at week 8 will be assessed. The scale itself assesses the level of disability from borderline personality disorder (or target disorder) with higher scores indicating a more debilitating disorder. | 8 weeks |
| Caplyta |
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. Caplyta: Atypical antipsychotic. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score | The ZAN-BPD is a clinician-administered scale assessing borderline personality disorder symptom severity (total scores range from 0-36). Higher scores indicate more severe symptoms. | Mean | Standard Deviation | Units on a scale |
|
| OG001 | Caplyta | 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. Caplyta: Atypical antipsychotic. |
|
|
| Secondary | Change in Modified Overt Aggression Scale (MOAS) Total Score | The MOAS is a clinician-administered behavior rating scale measuring four types of aggressive behavior. The MOAS will be administered at all 5 visits, but only the change from baseline to visit 5 at week 8 will be reported. The total weighted scores range from 0-40, with 0 indicating no aggression. Higher total scores indicate higher aggression levels. | The number of participants who completed the trial is less than the number of subjects who were enrolled. | Posted | Mean | Standard Deviation | Score on a scale | 8 weeks |
|
|
|
| Secondary | Change in Young Mania Rating Scale (YMRS) Total Score | The YMRS is a clinician-administered, 11-item scale assessing manic symptoms at baseline and over time. The YMRS will be administered at all 5 visits, but only the change from baseline to visit 5 at week 8 will be reported. Higher total scores (ranging from 0-60) indicate higher severity of manic symptoms. This scale is used to rate the severity of manic abnormality in participants. | The number of participants who completed the trial is less than the number of subjects who were enrolled. | Posted | Mean | Standard Deviation | Score on a scale | 8 weeks |
|
|
|
| Secondary | Change in Zanarini Rating Scale for Borderline Personality Disorder Self-Report Version (ZAN-BPD-SRV) Total Score | The ZAN-BPD-SRV is a self-report scale assessing borderline personality severity that will be assessed at all 5 visits. However, only the change from baseline to visit 5 at week 8 will be reported. Scoring is done by counting the number of yes's. Total scores range from 0-36, with higher scores indicating more severe symptoms. A score of 8 or more is indicative of a diagnosis of borderline personality disorder. | The number of participants who completed the trial is less than the number of subjects who were enrolled. Additionally, some subjects did not complete this self-report form at the end of the trial. | Posted | Mean | Standard Deviation | Score on a scale | 8 weeks |
|
|
|
| Secondary | Change in Borderline Evaluation of Severity Over Time (BEST) Total Score | The BEST is a self-rated scale used to measure severity and change. The first 12 items of the scale are scored on a scale from 1-5, with 5 meaning that the item caused extreme distress, severe difficulties in relationships, and/or kept the participant from getting things done. The lowest rating (1) means it caused little or no problems. Items 13-15 (positive behaviors) are rated according to frequency. The BEST will be administered at all 5 visits, but only the change from baseline to visit 5 at week 8 will be reported. | Not Posted | Aug 2026 | 8 weeks | Participants |
| Secondary | Change in Barratt Impulsiveness Scale (BIS-11) Total Score | This BIS-11 is a self-report assessment of impulsivity that will be assessed at baseline and Visit 5. The change from baseline to visit 5 at week 8 will be reported. All items are added to result in a total score ranging from 30-120. Higher total scores indicate higher impulsiveness. | Not Posted | Aug 2026 | 8 weeks | Participants |
| Secondary | Minnesota Impulsive Disorders Interview (MIDI) | The MIDI is a clinical interview that screens for a variety of impulsive disorders, including buying disorder, kleptomania, trichotillomania, intermittent explosive disorder, pyromania, gambling disorder, compulsive sexual behavior, and binge eating disorder. | Not Posted | Aug 2026 | 8 weeks | Participants |
| Secondary | Change in Hamilton Depression Rating Scale (HAM-D) Total Score | The HAM-D is a clinician-administered assessment of depression that will be assessed at all 5 study visits. However, only the change from baseline to visit 5 at week 8 will be reported. Higher total scores (ranging from 0-52) indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms. | The number of participants who completed the trial is less than the number of subjects who were enrolled. | Posted | Mean | Standard Deviation | Score on a scale | 8 weeks |
|
|
|
| Secondary | Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score | The HAM-A is a clinician-administered assessment of anxiety that will be assessed at all 5 study visits. However, only the change from baseline to visit 5 at week 8 will be reported. Higher total scores (ranging from 0-56) indicate higher levels of anxiety, with 0 being no symptoms of anxiety. | The number of participants who completed the trial is less than the number of subjects who were enrolled. | Posted | Mean | Standard Deviation | Score on a scale | 8 weeks |
|
|
|
| Secondary | Change in Quality of Life Inventory (QOLI) Total Weighted Satisfaction Score | The QOLI is a self-report assessment of patient perceived quality of life that will be assessed at baseline and visit 5. The change in total weighted satisfaction scores from baseline to visit 5 at week 8 will be reported. Higher scores (ranging from -96 to 96) indicate a higher quality of life, whereas lower scores indicate a lower quality of life. | The number of participants who completed the trial is less than the number of subjects who were enrolled. Additionally, some subjects did not complete this self-report form at the end of the trial. | Posted | Mean | Standard Deviation | Score on a scale | 8 weeks |
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|
|
| Secondary | Change in Sheehan Disability Scale (SDS) Total Score | Subjects will complete the SDS at all 5 visits. The change in total scores (ranging from 0-30) from baseline to visit 5 at week 8 will be assessed. The scale itself assesses the level of disability from borderline personality disorder (or target disorder) with higher scores indicating a more debilitating disorder. | The number of participants who completed the trial is less than the number of subjects who were enrolled. Additionally, some subjects did not complete this self-report form at the end of the trial. | Posted | Mean | Standard Deviation | Score on a scale | 8 weeks |
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| 0 |
| 31 |
| 1 |
| 31 |
| 16 |
| 31 |
| EG001 | Caplyta | 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. Caplyta: Atypical antipsychotic. | 0 | 29 | 0 | 29 | 14 | 29 |
| Hyperthyroidism | Endocrine disorders | Non-systematic Assessment |
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| Drowsiness | Nervous system disorders | Non-systematic Assessment |
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| Fatigue | Nervous system disorders | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Hot flash | Endocrine disorders | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| Insomnia | Nervous system disorders | Non-systematic Assessment |
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| Depressed mood | Psychiatric disorders | Non-systematic Assessment |
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| Tremor | Nervous system disorders | Non-systematic Assessment |
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