US 201401.00249A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2014/0100249 A1 Sears et al. (43) Pub. Date: Apr. 10, 2014 (54) THERAPEUTIC TREATMENT A63/37 (2006.01) A613 L/45 (2006.01) (71) Applicants: Douglas Sears, Oak Park, CA (US); A613 L/4458 (2006.01) Michael Reilly, Oak Park, CA (US) (52) U.S. Cl. CPC ............... A61K 45/06 (2013.01); A61 K3I/451 (72) Inventors: Douglas Sears, Oak Park, CA (US); (2013.01): A613 L/4458 (2013.01); A61 K Michael Reilly, Oak Park, CA (US) 3 1/137 (2013.01); A61 K31/165 (2013.01) USPC .......................................................... S14/325 (21) Appl. No.: 14/046,528 (57) ABSTRACT (22) Filed: Oct. 4, 2013 This invention discloses a treatment for a patient receiving O O medication to treat an attention deficit disorder Such as Related U.S. Application Data ADHD wherein the treatment results in a loss of appetite and (60) Provisional application No. 61/744,948, filed on Oct. impairment of the patient's attentiveness. The treatment com 9, 2012, now abandoned. bines a treatment for an attention deficit disorder with an appetite stimulant, wherein the appetite stimulant increases Publication Classification the caloric intake of a patient, which can increase the patients attentiveness. The combination treatment can be given for an (51) Int. Cl. indefinite, including, without limitation, life-long, to allow a A6 IK 45/06 (2006.01) patient to maintain normal caloric intake during treatment for A6 IK3I/65 (2006.01) an attention deficit disorder. 8aasaias: Patent Application Publication Apr. 10, 2014 Sheet 1 of 22 US 2014/010O249 A1 Figure i: improvement in Atiention with increased Caiotic intake 8aakast Patent Application Publication Apr. 10, 2014 Sheet 2 of 22 US 2014/010O249 A1 Figure 2: Impact of Combination Treatment of Weight Mean Slope with combination tx " a 13.97 g/day & Faie A & Patients & Pace Xie Katie E. & 8: F 's, 8:3 •. ate :- year Siope before combination tx at 3,46 gfday & -30% : -3.3% frastnert say Patent Application Publication Apr. 10, 2014 Sheet 3 of 22 US 2014/010O249 A1 Figure 3: Impact of Combination Treatinent or Height in pact of Cypra on height -35%. -- X-Sesses. x8x serias S. Sees: s:xx-x-Series: - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -20%---------------------------------------------- Patent Application Publication Apr. 10, 2014 Sheet 4 of 22 US 2014/010O249 A1 Figure 4: Change in Weight and ieight for Patiant A 338 18% f8. 18% 338 M8-3age is ti:isit : M8-ia:g: Ex weight : {x}% Patent Application Publication Apr. 10, 2014 Sheet 5 of 22 US 2014/010O249 A1 Figure 5: ADID Sensitivity (CGE-S} for Patient A 3 388 R&R 3. As s s 88: 83 Patent Application Publication Apr. 10, 2014 Sheet 6 of 22 US 2014/010O249 A1 figure 6: Change in Height and Weight of Patient B x Cage it waight x8x{iage in height. 88: 3:38 X 8:8 388 Ereatentisy Patent Application Publication Apr. 10, 2014 Sheet 7 of 22 US 2014/010O249 A1 Figure 7: Ai f: E Sensitivity (CG-S) for Patient A a. 3 a: 8. 8. 388 8. 33 treatsasi & Patent Application Publication Apr. 10, 2014 Sheet 8 of 22 US 2014/010O249 A1 Figure 8. Change in Height and Weight for Patient C 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 8 a 1838, :-y/ - - - - - - - - - - - - - -i - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - ×(8::::::::: weig: 8 - M8-C83:g: iaixeg: ;: 8 ava 100% x&&.------------------------------- f . * f 8:8%.38 -------------------------------------------------&-------------------y ; --------------------------------------------------------- % ; 8 96% ir\X8. - - - - - - -f- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8 3:38. -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3 28 38 a. S: G Patent Application Publication Apr. 10, 2014 Sheet 9 of 22 US 2014/010O249 A1 Figure 9: ADHD Sensitivity (CGi-S) for Patient C 3 :--------------------------------------------------------------------------------------------------------------------------------------------------------------------------- 2 :. 38 33 &3 is: Sis R Treatisant Day Patent Application Publication Apr. 10, 2014 Sheet 10 of 22 US 2014/010O249 A1 Figure : ). Change in Weight and Height of Patient C x8:::::ge is: weight 3 SC a: s: 83 38 2. : 83 Patent Application Publication Apr. 10, 2014 Sheet 11 of 22 US 2014/010O249 A1 Figure it: AIEEE Sensitivity (CGi-S) for Patient D 8. 283 8. S8. 8 88: 3.3 33 8. Patent Application Publication Apr. 10, 2014 Sheet 12 of 22 US 2014/010O249 A1 Figure 2: Change in hieight and Weight of Patient E X8. a: treatinent tay Patent Application Publication Apr. 10, 2014 Sheet 13 of 22 US 2014/010O249 A1 Figure 3: Ai iD Sensitivity (CGI-S for Patient E 2 : 4 irr; 233 &R 8X 88: i 3. 8 restset sy Patent Application Publication Apr. 10, 2014 Sheet 14 of 22 US 2014/010O249 A1 Figure 4: Change in Weight atti Eeight if Patient F Msw83::::::: weight s S. : RS: S. &B treatset sy Patent Application Publication Apr. 10, 2014 Sheet 15 of 22 US 2014/010O249 A1 Figure 5: ADHD Sensitivity (CG1-S for Patient F :- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8 S3 383 S38 88: s 3:33 Patent Application Publication Apr. 10, 2014 Sheet 16 of 22 US 2014/010O249 A1 Figure 6: Weight and Height Change of Patient G X Charge: weig: x Chaige ::::gigit reatnet sy Patent Application Publication Apr. 10, 2014 Sheet 17 of 22 US 2014/010O249 A1 Figure 7: AID}} E Sensitivity (CGi-S) for Patient G 83 8 388 3. 88: 883 88 83 Patent Application Publication Apr. 10, 2014 Sheet 18 of 22 US 2014/010O249 A1 Figure 8: Weight aris Height Change of Patient H X sixarge is weig: 8x88&tige it i:ight Patent Application Publication Apr. 10, 2014 Sheet 19 of 22 US 2014/010O249 A1 Figure 9: ADHD Sensitivity (CGI-S) for Patient H treatest Easy Patent Application Publication Apr. 10, 2014 Sheet 20 of 22 US 2014/010O249 A1 Figure 20; impact Of Combination Treatment or AIDHB Severty (CG-S) gss s: s : i.e. & Sier *:::Rie: 3 38: 83 s: treatinert Day retative to Etitiatio of Corioitatio 3'x Patent Application Publication Apr. 10, 2014 Sheet 21 of 22 US 2014/010O249 A1 Figure 2 : impact of Treatment on ADHD Severity (CGi-S) 3. 8. & 8: 8:38: x 8:38:3i: x Patent Application Publication Apr. 10, 2014 Sheet 22 of 22 US 2014/010O249 A1 Figure 22: impact of Treatment on improvement in ADHR (CGi-I) impact of Treatmenton improvementin ADHD (CG-I) & 88: 888:38.3: 3 & US 2014/010O249 A1 Apr. 10, 2014 THERAPEUTIC TREATMENT impulsively, reduced salary, poorer work performance scores, more frequent job changes, three times more likely to be 0001. This application claims the benefit of priority to unemployed, lower occupational attainment than patient IQ U.S. Provisional Patent Application 61/744.948, filed on Oct. would predict. Other functional impacts include a two times 4, 2012, which is hereby incorporated by reference in its more likely chance to be arrested, three times more likely to entirety. be convicted, fifteen times more likely to be incarcerated, a greater tendency toward antisocial/criminal behaviour, a BACKGROUND lower household income, higher accident claims and higher 0002 To treat psychological and/or neurological disor cost of accidents. (Goodman D. W. Primary Psychiatry: 17, 2 ders, including without limitation, attention deficit disorder, 2010) migrane, anti-serotonergic side effects, narcolepsy, excessive 0006 Various drugs and methods have been used to treat sleepiness associated with shift work, obstructive sleep apnea ADHD, including amphetamine and methylphenidate based as an adjunct to continuous positive airways pressure drugs. While these drugs are generally effective in treating (“CPAP), exogenous obesity, disruptive behaviour disorder ADHD, the side effects suffered by the children taking them including oppositional defiant disorder (“ODD) and conduct can include loss of appetite resulting in weight loss, insomnia, disorder (“CD), obesity, depression, neural insult, fatigue, drug dependence and loss of attentiveness. lethargy, binge eating disorder, Schizophrenia, sleep cycle 0007. With regard to treatments for ADHD, one option disorder, disease related fatigue in depression and fibromy generally followed by clinicians is to prescribe the use of algia, cocaine addiction, Parkinson's Disease, combat and short-acting stimulants. These are often used as an initial non-combat related PTSD, tic, and any other psychological treatment in small children (<16 kg), but these drugs have the and/or neurological syndrome it is common to prescribe to a disadvantage of requiring that they be administered twice a patient a therapeutic regimen that includes an amphetamine day (“b.i.d.) or three times a day (“t.i.d.) to provide control and/or methylphenidate. An attention deficit disorder for over a child’s ADHD symptoms throughout day. Longer act which these therapeutics are generally prescribed is attention ing stimulants offer greater convenience, confidentiality, and deficit hyperactivity