Methods, system, and kit for monitoring, diagnosing, and treating impulsive aggression

Patent metadata

Field	Value
Publication number	US-2022016128-A1
Application number	US-202117489619-A
Country	US
Kind code	A1
Filing date	Sep 29, 2021
Priority date	Apr 29, 2016
Publication date	Jan 20, 2022
Grant date	—

Abstract

The present disclosure relates to the treatment of impulsive aggression with molindone as an add-on therapy where patients are already receiving treatment for the underlying disease or disorder, e.g. attention deficit hyperactivity disorder (ADHD), bipolar disorder, autism, Tourette's syndrome or post traumatic stress disorder (PTSD), using evidence-based impulsive aggression testing methodologies and systems.

First claim

1 . A method of treating a patient having impulsive aggression (IA) by administering an impulsive aggression intervention, comprising:
(a) monitoring the patient for one or more aggressive episodes by:
providing the patient or a caregiver of the patient with a questionnaire to determine a pre-intervention baseline cumulative score of the patient,
initiating an impulsive aggression intervention treatment, and
providing the patient or the caregiver with the questionnaire to determine a post-intervention cumulative score of the patient; and either
(b) continuing to administer the impulsive aggression intervention treatment if the post-intervention cumulative score is lower than the pre-intervention baseline cumulative score; or (c) varying the impulsive aggression intervention treatment if the post-intervention cumulative score is not lower than the pre-intervention baseline cumulative score.

2 - 7 . (canceled)

8 . The method of claim 1 wherein the pre-intervention baseline cumulative score is calculated by monitoring the patient having impulsive aggression for one or more aggressive episodes prior to administration of the impulsive aggression intervention treatment.

9 . The method of claim 1 , wherein the questionnaire comprises a diary used by the patient or the caregiver to report each of the one or more aggressive episodes as observed.

10 . The method of claim 9 , wherein the questionnaire further prompts the caregiver to review each of the one or more aggressive episodes reported for a day and enter any aggressive episodes that were not previously reported.

11 . The method of claim 1 , wherein each of the one or more aggressive episodes is characterized by one or more behaviors from a group of behaviors comprising yelling, screaming, threatening, scratching, throwing, slamming, hitting self, arguing, cursing, name calling, shoving, hair pulling, fighting, hitting others, and kicking others; and wherein each of the one or more behaviors are coded as observed (coded 1) or not observed (coded 0) based on answers from the patient or the caregiver.

12 . The method of claim 11 , wherein a frequency of one or more behaviors over a fixed period of time is calculated to generate a score.

13 . The method of claim 12 , wherein the fixed period of time is a day, a week, a month, or a year.

14 . The method of claim 12 , wherein the pre-intervention baseline cumulative score is calculated based on two scores, each representing the frequency of the one or more behaviors provided in the questionnaire; and wherein the post-intervention cumulative score is calculated based on two scores, each representing the frequency of the one or more behaviors provided in the questionnaire.

15 . The method of claim 14 , wherein the pre-intervention baseline cumulative first score is calculated based on the frequency of a group of behaviors consisting of: yelling, screaming, threatening, scratching, throwing, slamming, and hitting self; and wherein the pre-intervention baseline cumulative second score is calculated based on the frequency of a group of behaviors consisting of: arguing, cursing, name calling, shoving, hair pulling, fighting, hitting others, and kicking others.

16 . The method of claim 1 , wherein the pre-intervention baseline cumulative score and the post-intervention cumulative score is calculated as a weighted score.

17 . The method of claim 1 , wherein the pre-intervention baseline cumulative score and the post-intervention cumulative score is calculated as an unweighted score.

18 . The method of claim 1 , wherein the impulsive aggression intervention treatment administered is selected from behavioral therapy or administration of molindone.

19 . The method of claim 18 , wherein the impulsive aggression intervention treatment is administration of molindone according to a dose or dose regimen.

20 . The method of claim 19 , wherein the dose of molindone is between about 3 mg and about 36 mg.

21 . The method of claim 20 , wherein the dose of molindone is about 18 mg.

22 . The method of claim 20 , wherein the dose of molindone is about 36 mg.

23 . The method of claim 19 , wherein continued administration of the impulsive aggression intervention comprises maintaining, increasing, or lowering the dose of molindone.

24 . The method of claim 1 , wherein the patient is a child or an adolescent.

25 . The method of claim 24 , wherein the child is between the ages of about 6 to about 12.

26 . The method of claim 24 , wherein the adolescent is between the ages of about 12 to about 17.

27 . The method of claim 1 wherein the patient having impulsive aggression has impulsive aggression associated with a primary condition.

28 . The method of claim 27 , wherein the primary condition is attention deficit hyperactivity disorder (ADHD), bipolar disorder, autism, Tourette's syndrome, or post-traumatic stress disorder (PTSD).

29 - 94 . (canceled)

95 . The method of claim 1 , wherein the impulsive aggression intervention treatment initiated is a secondary treatment.

96 . The method of claim 13 , wherein the fixed period of time is a week or seven days.

97 . The method of claim 14 , wherein the post-intervention cumulative first score is calculated based on the frequency of a group of behaviors consisting of: yelling, screaming, threatening, scratching, throwing, slamming, and hitting self; and wherein the post-intervention cumulative second score is calculated based on the frequency of a group of behaviors consisting of: arguing, cursing, name calling, shoving, hair pulling, fighting, hitting others, and kicking others.

98 . The method of claim 19 , wherein the dose of molindone is between about 12 mg and about 36 mg.

99 . The method of claim 20 , wherein the dose of molindone is about 12 mg.

Assignees

• Supernus Pharmaceuticals Inc

Inventors

• Stocks Jennifer Dugan
• Evans Christopher
• Hwang Seung
• Dallabrida Susan M

Classifications

• A61P25/18

  Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia · CPC title

• A61P25/14

  for treating abnormal movements, e.g. chorea, dyskinesia · CPC title

• G16H10/20

  for electronic clinical trials or questionnaires · CPC title

• A61P25/20

  Hypnotics; Sedatives · CPC title

• G16H50/30

  for calculating health indices; for individual health risk assessment · CPC title