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

Caplyta in Borderline Personality Disorder

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 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 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 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 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. Items 13-15 are rated 1-5 with 5 indicating more frequent symptoms. The scale ranges from 12-72 with higher scores indicating more severe symptoms. The score for items 1-12 are added together, the score from items 13-15 are then subtracted, and then 15 is added to obtain the total score. The BEST will be administered at all 5 visits, but only the change from baseline to visit 5 at week 8 will be reported.

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.

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, binge eating disorder, and compulsive exercise. The results of the MIDI at baseline will be reported.

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 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 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.

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.