(12) Patent Application Publication (10) Pub. No.: US 2016/0000815 A1 BIRD (43) Pub

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(12) Patent Application Publication (10) Pub. No.: US 2016/0000815 A1 BIRD (43) Pub US 2016.0000815A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2016/0000815 A1 BIRD (43) Pub. Date: Jan. 7, 2016 (54) COMPOSITIONS AND METHODS FOR Publication Classification TREATING PSYCHATRIC DISORDERS (51) Int. Cl. (71) Applicant: GOSFORTH CENTRE (HOLDINGS) A613 L/7048 (2006.01) PTY LTD., Maroochydore (AU) A613 L/4458 (2006.01) A613 L/466 (2006.01) (72) Inventor: Philip BIRD, Maroochydore (AU) A63/37 (2006.01) A613 L/19 (2006.01) (52) U.S. Cl. (21) Appl. No.: 14/679,559 CPC ........... A6 IK3I/7048 (2013.01); A61 K3I/I37 (2013.01); A61 K3I/19 (2013.01); A61 K 31/4166 (2013.01); A61 K3I/4458 (2013.01) (22) Filed: Apr. 6, 2015 (57) ABSTRACT Methods of treating psychiatric disorders are provided which Related U.S. Application Data include administration of one or more anti-epileptic agents (63) Continuation of application No. 13/057,628, filed on and, optionally, one or more a psychostimulants. Also pro May 6, 2011, now abandoned, filed as application No. vided are pharmaceutical compositions comprising, in com PCT/AU2009/001000 on Aug. 6, 2009. bination, one or more anti-epileptic agents and one or more psychostimulants. Psychiatric disorders include those asso (30) Foreign Application Priority Data ciated with impaired cognitive processing, degenerative dis orders such as Mild Cognitive Impairment, Parkinson's dis Aug. 6, 2008 (AU) ................................ 20O8904O16 ease, dementia, non-compliance with therapeutic regimes Aug. 6, 2008 (AU) ................................ 20O8904O21 and eating disorders, although without limitation thereto. US 2016/0000815 A1 Jan. 7, 2016 COMPOSITIONS AND METHODS FOR SUMMARY OF THE INVENTION TREATING PSYCHATRC DSORDERS 0004. The present inventor has extended initial observa tions in treating ADHD and certain other DSM-IV-TR disor FIELD OF THE INVENTION ders with anti-epileptic agents, alone or in combination with 0001 THIS INVENTION relates to therapy of psychiatric a psychoStimulant, to treatment of other psychiatric disor disorders using anti-epileptic agents, alone or in combination ders. Particularly, although not exclusively, the present inven with a psychoStimulant. In particular, the invention relates to tion addresses a significant need for effective treatment methods and compositions for treating psychiatric disorders options for therapy of psychiatric disorders with an underly associated with impaired, abnormal or reduced cognitive pro ing defect or abnormality in cognitive processes associated cessing, particularly that which enables higher executive with higher order executive functioning. functioning. 0005. In a first aspect the invention provides a method of treating a psychiatric disorder other than epilepsy, bipolar BACKGROUND OF THE INVENTION disorder or attention deficit hyperactivity disorder (ADHD), in a subject in need thereof, including the step of administer 0002 Cognitive processing enables humans to selectively ing to the Subject one or more anti-epileptic agents, or phar attend, filter, reflect and prioritise incoming information and maceutically acceptable salt thereof, to thereby treat the psy integrate this with thoughts and ideas. These processes are chiatric disorder, wherein the amount of anti-epileptic agent particularly important for higher executive function. Execu is sub-therapeutic for mood stabilization treatment of epi tive functions are necessary for goal-directed behavior. They lepsy or epileptic symptoms. include the ability to initiate and stop actions, to monitor and 0006. In a second aspect, the invention provides one or change behavior as needed, and to plan future behavior when more anti-epileptic agents, or pharmaceutically acceptable faced with novel tasks and situations. Executive functions salt thereof, for use in treating a psychiatric disorder other include a set of cognitive abilities that control and regulate than epilepsy, bipolar disorder or attention deficit hyperactiv other abilities and behaviours, to allow humans to anticipate ity disorder (ADHD), wherein the amount of anti-epileptic outcomes and adapt to changing situations. Further, the abil agent is sub-therapeutic for mood Stabilization treatment of ity to form new concepts and think abstractly is often consid epilepsy or epileptic symptoms. ered a component of executive function. In particular, this includes the cognitive functions of sequencing, organising 0007 Preferably, the psychiatric disorder of the first and and integrating Social information and appears to be used second aspects is not a DSM-IV-TR Communication Disor during the complex interpersonal interaction which forms the der, Pervasive Development Disorder or Anxiety Disorder. basis of human social communication and interaction. Defec 0008. In a third aspect, the invention provides a method of tive or abnormal cognitive processing can therefore become treating a psychiatric disorder other than epilepsy, bipolar apparent in behaviours that are controlled by higher executive disorder or attention deficit hyperactivity disorder (ADHD), functioning. Defects in cognitive processing may result in in a subject in need thereof, including the step of administer hyper-focusing on a specific topic during conversation and/or ing to the Subject one or more anti-epileptic agents, or phar an inability to process simultaneously the multiple lines of maceutically acceptable salt thereof, and one or more psy thought that usually and automatically take place in normal chostimulants, orpharmaceutically acceptable salt thereof, to Social interaction. Instead the individual may select a pre thereby treat the psychiatric disorder, wherein the amount of ferred, more comfortable, and probably more familiar topic. anti-epileptic agent is Sub-therapeutic for mood stabilization As a consequence, resistance to or difficulty in following the treatment of epilepsy or epileptic symptoms. natural flow of conversation is apparent. 0009. In a fourth aspect, the invention provides one or 0003. Furthermore, compliance with pharmacotherapy is more anti-epileptic agents, or pharmaceutically acceptable a long standing and difficult problem with individuals both salt thereof, and one or more psychoStimulants, or pharma with and without attention and concentration impairment. ceutically acceptable salt thereof, in combination for use in Reduced compliance affects and potentially limits the effi treating a psychiatric disorder other than epilepsy, bipolar cacy of all interventions, frequently being the most limiting disorder or attention deficit hyperactivity disorder (ADHD), factor in providing Sustained psychotherapeutic benefit. For wherein the amount of anti-epileptic agent is Sub-therapeutic example, the 12 month compliance rate for use of psycho for mood stabilization treatment of epilepsy or epileptic stimulants in adults is approximately 33%. The core areas of symptoms. impairment appear to be in the sequence and organisation of 0010. In one embodiment of the aforementioned aspects, thoughts. This is seen clinically with adults with a diagnosis the psychiatric disorder is associated with an impairment or of attention deficit hyperactivity disorder (ADHD); a DSM deficiency in higher order executive functioning. IV-TR disorder as described in the Fourth Edition of the 0011. In another embodiment of the aforementioned Diagnostic and Statistical Manual of Mental Disorders aspects, the psychiatric disorder is not a developmental dis (American Psychiatric Association, 2000), and Snyder, Nuss order or a disorder usually diagnosed in infancy, childhood or baum, & Robins (Eds.), 2006, ibid (especially Box 2) and adolescence. Weiss & Murray, 2003 and most commonly treated with 0012. In yet another embodiment of the aforementioned psychostimulants. The initial and at times dramatic improve aspects, the psychiatric disorder is a degenerative disorder. ment frequently gives way to a returning disorganisation, and 0013. In still yet another embodiment of the aforemen non-adherence with medication and an eventual cessation of tioned aspects, the psychiatric disorder is a psychotic disor treatment. Unless there is a concurrent improvement in the der. automatic and effortless ability to process Social information, 0014. In still yet another embodiment of the aforemen the gains in motivation provided by the stimulant will inevi tioned aspects, the psychiatric disorder is associated with tably wane resulting in the associated return of symptoms. reduced adherence, or non-compliance, with a medication US 2016/0000815 A1 Jan. 7, 2016 regime that includes the administration of a therapeutic agent (a) from about 0.1 mg to 50 mg sodium valproate, or a deriva other than, or in addition to, a psychoStimulant. tive thereof, and from 0.1 to 20 mg dextroamphetamine sul 0.015. In a further embodiment of the aforementioned phate; (b) from about 1 mg to 400 mg sodium valproate, or a aspects, the psychiatric disorder is an eating disorder. derivative thereof, and from 1 to 200 mg dextroamphetamine 0016. In certain particular embodiments, the psychiatric Sulphate; (c) from about 0.5 mg to 80 mg topiramate and from disorder is selected from the group consisting of degenera 1 to 400 mg methylphenidate; (d) from about 0.5 mg to 80 mg tive disorders and/or movement disorders such as Parkinson's topiramate and from 1 to 200 mg dextroamphetamine Sul disease, dementia and Mild Cognitive Impairment; addiction; phate; (e) from about 0.25 mg to 80 mg phenytoin and from 1 reduced adherence, or non-compliance, with a medication to 400 mg methylphenidate,
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