Treatment for Neurological and Mental Disorders

• US 20110053956A1
• Filed: 11/09/2010
• Published: 03/03/2011
• Est. Priority Date: 05/30/2008
• Status: Abandoned Application

• Current Assignee: PsychoGenics Inc.
• Original Assignee: PsychoGenics Inc.
• Inventors: Leahy, Emer, Day, Mark
• Application Number:
  US12/942,408
• Publication Number:
  US 20110053956A1
• Time in Patent Office: Days
• US Class Current: 514/254.11
• CPC Class Codes: A61K 31/496 Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61P 25/00 Drugs for disorders of the nervous system
• CPC Class Codes: A61P 25/14 for treating abnormal movements, e.g. chorea, dyskinesia
• CPC Class Codes: A61P 25/16 Anti-Parkinson drugs
• CPC Class Codes: A61P 25/18 Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
• CPC Class Codes: A61P 25/22 Anxiolytics
• CPC Class Codes: A61P 25/24 Antidepressants
• CPC Class Codes: A61P 25/28 for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
• CPC Class Codes: A61P 25/30 for treating abuse or dependence
• CPC Class Codes: A61P 25/36 Opioid-abuse
• CPC Class Codes: A61P 5/38 of the suprarenal hormones
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

Methods for treating neurological or mental disorders in humans and the symptoms associated therewith are provided by administering eltoprazine and/or related compounds. In some embodiments, specific symptoms are treated by administering eltoprazine and/or a related compound in an effective amount to ameliorate the symptoms. Of particular significance are symptoms that are associated with cognitive dysfunction where eltoprazine will improve the symptoms and the disorder associated with that symptom. Of particular interest are non-ADHD-associated inattention, hyperactivity and impulsiveness. The methods provided herein are especially useful for improving functional recovery after CNS injury such as stroke where improved cognitive function will facilitate the acquisition of learning and memory of rehabilitative tasks.

Claims

1. A method of treating symptoms of schizophrenia unassociated with aggression, comprising administering to an individual in need thereof an effective amount of eltoprazine or a pharmaceutically acceptable addition salt thereof, in combination with an antipsychotic agent.

3. The method according to claim 1 or 2, wherein the symptoms comprise one or more deficits in cognitive functioning.

4. The method according to claim 1 or 2, wherein the symptoms comprise one or more of the positive symptoms of schizophrenia.

5. The method according to claim 1 or 2, wherein the symptoms comprise one or more of the negative symptoms of schizophrenia.

6. The method according to claim 1 or 2, wherein eltoprazine is administered at a dose from about 0.1 mg/day to about 20 mg/day.

7. The method according to claim 1 or 2, wherein eltoprazine is administered at a dose from about 0.1 mg/day to about 10 mg/day.

8. The method according to claim 1 or 2, wherein eltoprazine is administered at a dose from about 1.0 mg/day to about 10 mg/day.

9. The method according to claim 1 or 2, wherein eltoprazine is administered at a dose from about 1.0 mg/day to about 5 mg/day.

10. The method according to claim 1 or 2, wherein eltoprazine is administered at a dose of about 2.5 mg/day.

11. The method according to claim 1 or 2, wherein eltoprazine is administered at a dose of about 5 mg/day.

12. The method according to claim 1 or 2, wherein eltoprazine is administered at a dose of about 10 mg/day.

13. The method according to claim 1 or 2, wherein eltoprazine is administered at a dose of about 20 mg/day.

14. The method according to claim 1 or 2, wherein eltoprazine is administered twice per day, and wherein said administrations are equal in amount.

15. The method according to claim 12, wherein eltoprazine is administered twice per day, and wherein about 5 mg is administered in the beginning half of the day, and about 5 mg is administered in the latter half of the day.

16. The method according to claim 13, wherein eltoprazine is administered twice per day, and wherein about 10 mg is administered in the beginning half of the day, and about 10 mg is administered in the latter half of the day.

17. The method according to claim 1 or 2, wherein eltoprazine is administered in a controlled release or sustained release dosage form.

18. The method according to claim 17, wherein eltoprazine is administered subcutaneously.

2. A method of treating symptoms of schizophrenia unassociated with aggression, comprising administering to an individual in need thereof an effective amount of eltoprazine or a pharmaceutically acceptable addition salt thereof, in combination with a 5-HT_1a receptor agonist.

19. A method of treating suicidality, comprising administering to an individual in need thereof an effective amount of eltoprazine or a pharmaceutically acceptable addition salt thereof, in combination with an antipsychotic agent or a 5-HT_1a receptor agonist.

20. A method of treating symptoms of schizophrenia unassociated with aggression, comprising administering to an individual in need thereof an effective amount of eltoprazine or a pharmaceutically acceptable addition salt thereof, wherein said eltoprazine is administered at a dose from about 0.1 mg/day to about 20 mg/day.

21. The method according to claim 20, wherein the symptoms comprise one or more deficits in cognitive functioning.

22. The method according to claim 20, wherein the symptoms comprise one or more of the positive symptoms of schizophrenia.

23. The method according to claim 20, wherein the symptoms comprise one or more of the negative symptoms of schizophrenia.

24. The method according to claim 20, wherein eltoprazine is administered at a dose from about 0.1 mg/day to about 10 mg/day.

25. The method according to claim 20, wherein eltoprazine is administered at a dose from about 1.0 mg/day to about 10 mg/day.

26. The method according to claim 20, wherein eltoprazine is administered at a dose from about 1.0 mg/day to about 5 mg/day.

27. The method according to claim 20, wherein eltoprazine is administered at a dose of about 2.5 mg/day.

28. The method according to claim 20, wherein eltoprazine is administered at a dose of about 5 mg/day.

29. The method according to claim 20, wherein eltoprazine is administered at a dose of about 10 mg/day.

30. The method according to claim 20, wherein eltoprazine is administered at a dose of about 20 mg/day.

31. The method according to claims 20, wherein eltoprazine is administered twice per day, and wherein said administrations are equal in amount.

32. The method according to claim 29, wherein about 5 mg of eltoprazine is administered in the beginning half of the day, and about 5 mg of eltoprazine is administered in the latter half of the day.

33. The method according to claim 30, wherein about 10 mg of eltoprazine is administered in the beginning half of the day, and about 10 mg of eltoprazine is administered in the latter half of the day.

34. The method according to claim 20, wherein eltoprazine is administered in a delayed release dosage form.

35. The method according to claim 34, wherein eltoprazine is administered subcutaneously.

36. A method of treating suicidality, comprising administering to an individual in need thereof an effective amount of eltoprazine or a pharmaceutically acceptable addition salt thereof, wherein said eltoprazine is administered at a dose from about 0.1 mg/day to about 20 mg/day.