边缘性人格障碍中的Caplyta

安慰剂比较：安慰剂

从研究的第一周开始，所有被随机分配到安慰剂组的受试者将接受与实验药物相同的安慰剂药丸。 将每两周对受试者进行一次观察，持续 8 周。 研究结束后（第 8 周），将停止服药。

药品：安慰剂

不含药物的药丸。

其他名称：

• 没有其他名字

实验性的：Caplyta

从研究的第一周开始，所有被随机分配到 Caplyta 的受试者将接受 42mg/天的剂量。 将每两周对受试者进行一次观察，持续 8 周。 不允许更改和减少剂量。 研究结束后（第 8 周），将停止服药。

药品：Caplyta

非典型抗精神病药

其他名称：

• 苯丙酮

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.

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.

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.

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.

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.

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.

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.

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.

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.

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. 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.

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