Trial Outcomes & Findings for Caplyta in Borderline Personality Disorder (NCT NCT05356013)

Caplyta in Borderline Personality Disorder

A clinician-administered scale assessing borderline personality disorder symptom severity (total scores range from 0-36). Higher scores indicate more severe symptoms.

A clinician-administered behavior rating scale measuring four types of aggressive behavior that will be assessed at all 9 visits. The subsets range on a scale from 0-4 with 0 indicating no aggression present. This scale tracks changes in level of aggression over time. The total weighted sum of the sections of the scale is recorded. Higher total scores indicate higher aggression levels.

A clinician-administered, 11 item scale that assesses manic symptoms at baseline and over time. Higher total scores indicate higher severity of manic symptoms. This scale is used to rate the severity of manic abnormality in the patient. Subsets of the scale range from 0-4 with 0 indicating no severity. This scale will be assessed at all visits.

A self-report scale assessing Borderline Personality severity that will be assessed at all 5 visits. This scale is assessing severity and change in BPD symptoms. Scoring is done by counting the number of yes's. A score of 8 or more is indicative of a diagnosis of borderline personality disorder.

A self rated scale used to measure severity and change. The first 12 items of the scale are on a scale from 1-5, with 5 meaning that the item caused extreme distress, severe difficulties in relationships, and/or kept them 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. This scale will be assessed at all visits.

A self-report assessment of impulsivity that will be assessed at baseline and Visit 5. All items are added to result in a total score. Higher total scores indicate higher impulsiveness.

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.

A clinician-administered assessment of depression that will be assessed at all study visits. Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms.

A clinician-administered assessment of anxiety that will be assessed at all study visits. Changes in scores from baseline to final visit will be assessed. Higher scores indicate higher levels of anxiety, with 0 being no symptoms of anxiety.

A self-report assessment of patient perceived quality of life that will be assessed at baseline and visit 5. Higher scores indicate a higher quality of life, whereas lower scores indicate a lower quality of life.

Subjects will complete the SDS at all visits. The change in scores from baseline to study completion 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.