Method of treating schizophrenia or schizophreniform disorder

Abstract

Described herein are compositions which include digestive enzymes which are formulated to reduce one or more symptoms of a neuropsychiatric disorder. Also described herein is a method for treating an individual with a neuropsychiatric disorder using digestive enzymes and their derivatives to alleviate the symptoms of neuropsychiatric disorders. The method comprises administering to the individual an effective amount of digestive enzymes that are either naturally- or recombinantly-derived, or their derivatives, in an amount effective to reduce one or more symptoms of the neuropsychiatric disorder.

What is claimed is: 
     
         1 . A method for preventing or treating a patient exhibiting one or more symptoms of a neuropsychiatric disorder comprising administering a therapeutically effective amount of a composition comprising digestive enzymes to the individual, wherein one or more symptoms of said neuropsychiatric disorder are treated. 
     
     
         2 . The method of  claim 1 , wherein the neuropsychiatric disorder is a schizophreniform disorder or a mild anxiety state. 
     
     
         3 . The method of  claim 2 , wherein said schizophreniform disorder is schizophrenia or psychosis. 
     
     
         4 . A method for preventing or treating one or more symptoms of schizophrenia or psychosis in a patient administering a therapeutically effective amount of a composition comprising digestive enzymes to the individual, wherein said one or more symptoms of schizophrenia or psychosis are treated. 
     
     
         5 . The method of  claim 1 , wherein the one or more symptoms are selected from the group consisting of one or more positive symptoms, one or more negative symptoms, one or more symptoms of cognitive impairment, and a combination thereof. 
     
     
         6 . The method of  claim 4 , wherein the one or more symptoms are selected from the group consisting of one or more positive symptoms, one or more negative symptoms, one or more symptoms of cognitive impairment, and a combination thereof. 
     
     
         7 . The method of any one of  claims 1  to  6 , wherein said one or more symptoms are reduced in severity or duration by about 2%, about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 90%, about 95%, or about 100%. 
     
     
         8 . The method of  claim 7  wherein said composition is administered until one or more symptoms are partially or completely reduced. 
     
     
         9 . The method of  claim 7 , wherein said composition is administered 1, 2, 3 or 4 times a day until one or more symptoms are partially or completely reduced. 
     
     
         10 . The method of  claim 7 , wherein said composition is administered 1, 2, 3 or 4 times a week until one or more symptoms are partially or completely reduced. 
     
     
         11 . The method of  claim 7 , wherein said method further comprises administering one or more additional agents. 
     
     
         12 . The method of  claim 11 , wherein said one or more agents is an antipsychotic medication. 
     
     
         13 . The method of  claim 12 , wherein said antipsychotic medication is a dopamine antagonist or a serotonin antagonist. 
     
     
         14 . The method of any one of  claims 7 , wherein said method further comprises psychotherapy, vocational rehabilitation, social rehabilitation, or a combination thereof. 
     
     
         15 . The method of  claims 5  or  6 , wherein the one or more positive symptoms comprise hallucinations, delusions, disorganized thought, disorganized speech, movement disorders, bizarre behavior, or a combination thereof. 
     
     
         16 . The method of  claims 5  or  6 , wherein the one or more negative symptoms comprise loss of motivation, restricted range of emotional experience and expression, reduced hedonic capacity, affective flattening, alogia, avolition, or a combination thereof. 
     
     
         17 . The method of  claims 5  or  6 , wherein the one or more symptoms of cognitive impairment comprise poor executive function, inability to use learned information, difficulty paying attention and/or focusing, or a combination thereof. 
     
     
         18 . The method of  claims 1  or  4 , wherein the composition comprising digestive enzymes comprises amylases, lipases, proteases, or a combination thereof. 
     
     
         19 . The method of  claim 18 , wherein the composition further comprises chymotrypsin, trypsin, pancreatin, papain, or a combination thereof. 
     
     
         20 . The method of  claim 18 , wherein the digestive enzymes are derived from a source selected from the group consisting of animal enzymes, plant enzymes, synthetic enzymes, and a combination thereof. 
     
     
         21 . The method of  claim 20 , wherein the animal enzyme is derived from a mammal. 
     
     
         22 . The method of  claim 21 , wherein the mammal is a pig. 
     
     
         23 . The method of  claim 20 , wherein the animal enzyme is derived from a pancreas. 
     
     
         24 . The method of  claims 1  or  4 , wherein the compositions comprising digestive enzymes are manufactured using a technology selected from the group consisting of enteric coating, lipid encapsulation, direct compression, dry granulation, wet granulation, and a combination thereof. 
     
     
         25 . The method of  claim 24 , wherein the composition is administered orally. 
     
     
         26 . The method of  claim 24 , wherein said composition is a dosage formulation selected from the group consisting of pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, and a combination thereof. 
     
     
         27 . The method of  claim 18 , wherein the total amount of protease in said composition is from about 10,000 to about 1,500,000 U.S.P. units/dose. 
     
     
         28 . The method of  claim 27 , wherein the total amount of protease in said composition is about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 25,000; about 30,000; about 40,000; about 50,000; about 65,000; about 75,000; about 100,000; about 140,000; about 140,400; about 150,000; about 200,000; about 250,000; about 300,000; about 350,000; about 400,000; about 450,000; about 465,000; about 500,000; about 550,000; about 600,000; about 650,000; about 700,000; about 750,000; about 800,000; about 850,000; about 900,000; about 950,000; about 1,000,000; about 1,050,000; about 1,100,000; about 1,150,000; about 1,200,000; about 1,250,000; about 1,300,000; about 1,350,000; about 1,400,000; about 1,450,000; or about 1,500,000; about 1,200,000; about 1,250,000; about 1,300,000; about 1,350,000; about 1,400,000; about 1,450,000; or about 1,500,000 U.S.P. units/dose. 
     
     
         29 . The method of  claim 18 , wherein the total amount of amylase in said composition is from about 1,000 to about 15,000,000 U.S.P. units/dose. 
     
     
         30 . The method of  claim 29 , wherein the total amount of amylase in said composition is about 1,000; about 3,000; about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 25,000; about 30,000; about 40,000; about 50,000; about 65,000; about 75,000; about 100,000; about 144,000; about 500,000; about 1,000,000; about 2,000,000; about 3,000,000; about 4,000,000; about 5,000,000; about 6,000,000; about 7,000,000; about 8,000,000; about 9,000,000; about 10,000,000; about 11,000,000; about 12,000,000; about 13,000,000; about 14,000,000; and about 15,000,000 U.S.P. units/dose. 
     
     
         31 . The method of  claim 18 , wherein the total amount of lipase in said composition is from about 1,500 to about 282,000 U.S.P. units/dose. 
     
     
         32 . The method of  claim 31 , wherein the total amount of lipase in said composition is about 1,500; about 1,880; about 2,000; about 3,000; about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 23,000; about 23,040; about 25,000; about 30,000; about 40,000; about 50,000; about 65,000; about 75,000; about 100,000; about 125,000; about 150,000; about 200,000; about 250,000; and about 282,000 U.S.P. units/dose. 
     
     
         33 . A composition comprising digestive enzymes for use in the prevention or treatment of one or more symptoms of a neuropsychiatric disorder. 
     
     
         34 . The composition of  claim 33 , wherein the neuropsychiatric disorder is a schizophreniform disorder or a mild anxiety state. 
     
     
         35 . The composition of  claim 34 , wherein said schizophreniform disorder is schizophrenia or psychosis. 
     
     
         36 . A composition comprising digestive enzymes for use in the prevention or treatment of one or more symptoms of schizophrenia or psychosis. 
     
     
         37 . The composition of  claims 33  or  36 , wherein the one or more symptoms are selected from the group consisting of one or more positive symptoms, one or more negative symptoms, one or more symptoms of cognitive impairment, and a combination thereof. 
     
     
         38 . The composition of  claim 37 , wherein the one or more positive symptoms comprise hallucinations, delusions, disorganized thought, disorganized speech, movement disorders, bizarre behavior, or a combination thereof. 
     
     
         39 . The composition of  claim 37 , wherein the one or more negative symptoms comprise loss of motivation, restricted range of emotional experience and expression, reduced hedonic capacity, affective flattening, alogia, avolition, or a combination thereof. 
     
     
         40 . The composition of  claim 37 , wherein the one or more symptoms of cognitive impairment are comprise poor executive function, inability to use learned information, difficulty paying attention and/or focusing, or a combination thereof. 
     
     
         41 . The composition of  claims 33  or  36 , wherein the composition comprising digestive enzymes comprises amylases, lipases, proteases, or a combination thereof. 
     
     
         42 . The composition of  claim 41 , wherein the composition further comprises chymotrypsin, trypsin, pancreatin, papain, and a combination thereof. 
     
     
         43 . The composition of  claims 33  or  36 , wherein the digestive enzymes are derived from a source selected from the group consisting of animal enzymes, plant enzymes, synthetic enzymes, and a combination thereof. 
     
     
         44 . The composition of  claim 43 , wherein the animal enzyme is derived from a mammal. 
     
     
         45 . The composition of  claim 44 , wherein the mammal is a pig. 
     
     
         46 . The composition of  claim 43 , wherein the animal enzyme is derived from a pancreas. 
     
     
         47 . The composition of  claims 33  or  36 , wherein the compositions comprising digestive enzymes are manufactured using a technology selected from the group consisting of enteric coating, lipid encapsulation, direct compression, dry granulation, wet granulation, and a combination thereof. 
     
     
         48 . The composition of  claim 47 , wherein the composition is formulated for oral administration. 
     
     
         49 . The composition of  claim 47 , wherein said composition is a dosage formulation selected from the group consisting of pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, and a combination thereof. 
     
     
         50 . The composition of  claim 41 , wherein the total amount of protease in said composition is from about 10,000 to about 1,500,000 U.S.P. units/dose. 
     
     
         51 . The composition of  claim 50 , wherein the total amount of protease in said composition is about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 25,000; about 30,000; about 40,000; about 50,000; about 65,000; about 75,000; about 100,000; about 140,000; about 140,400; about 150,000; about 200,000; about 250,000; about 300,000; about 350,000; about 400,000; about 450,000; about 465,000; about 500,000; about 550,000; about 600,000; about 650,000; about 700,000; about 750,000; about 800,000; about 850,000; about 900,000; about 950,000; about 1,000,000; about 1,050,000; about 1,100,000; about 1,150,000; about 1,200,000; about 1,250,000; about 1,300,000; about 1,350,000; about 1,400,000; about 1,450,000; or about 1,500,000; about 1,200,000; about 1,250,000; about 1,300,000; about 1,350,000; about 1,400,000; about 1,450,000; or about 1,500,000 U.S.P. units/dose. 
     
     
         52 . The composition of  claim 41 , wherein the total amount of amylase in said composition is from about 1,000 to about 15,000,000 U.S.P. units/dose. 
     
     
         53 . The composition of  claim 52 , wherein the total amount of amylase in said composition is about 1,000; about 3,000; about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 25,000; about 30,000; about 40,000; about 50,000; about 65,000; about 75,000; about 100,000; about 144,000; about 500,000; about 1,000,000; about 2,000,000; about 3,000,000; about 4,000,000; about 5,000,000; about 6,000,000; about 7,000,000; about 8,000,000; about 9,000,000; about 10,000,000; about 11,000,000; about 12,000,000; about 13,000,000; about 14,000,000; and about 15,000,000 U.S.P. units/dose. 
     
     
         54 . The composition of  claim 41 , wherein the total amount of lipase in said composition is from about 1,500 to about 282,000 U.S.P. units/dose. 
     
     
         55 . The composition of  claim 54 , wherein the total amount of lipase in said composition is about 1,500; about 1,880; about 2,000; about 3,000; about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 20,000; about 23,000; about 23,040; about 25,000; about 25,000; about 30,000; about 40,000; about 50,000; about 65,000; about 75,000; about 100,000; about 125,000; about 150,000; about 200,000; about 250,000; and about 282,000 U.S.P. units/dose. 
     
     
         56 . Use of a composition of any one of  claims 33 - 55  in the formulation of a medicament for the treatment of one or more symptoms of a neuropsychiatric disorder. 
     
     
         57 . The use of  claim 56 , wherein the neuropsychiatric disorder is a schizophreniform disorder or a mild anxiety state. 
     
     
         58 . The use of  claim 57 , wherein said schizophreniform disorder is schizophrenia or psychosis. 
     
     
         59 . The use of  claim 56 , wherein the one or more symptoms are selected from the group consisting of one or more positive symptoms, one or more negative symptoms, one or more symptoms of cognitive impairment, and a combination thereof. 
     
     
         60 . The use of  claim 59 , wherein the one or more positive comprise hallucinations, delusions, disorganized thought, disorganized speech, movement disorders, bizarre behavior, or a combination thereof. 
     
     
         61 . The use of  claim 59 , wherein the one or more negative symptoms comprise loss of motivation, restricted range of emotional experience and expression, reduced hedonic capacity, affective flattening, alogia, avolition, or a combination thereof. 
     
     
         62 . The use of  claim 59 , wherein the one or more symptoms of cognitive impairment comprise poor executive function, inability to use learned information, difficulty paying attention and/or focusing, or a combination thereof. 
     
     
         63 . The use of  claim 56 , wherein the composition comprising digestive enzymes comprises amylases, lipases, proteases, or a combination thereof. 
     
     
         64 . The use of  claim 63 , wherein the composition further comprises chymotrypsin, trypsin, pancreatin, papain, and a combination thereof. 
     
     
         65 . The use of  claim 56 , wherein the digestive enzymes are derived from a source selected from the group consisting of animal enzymes, plant enzymes, synthetic enzymes, and a combination thereof. 
     
     
         66 . The use of  claim 65 , wherein the animal enzyme is derived from a mammal. 
     
     
         67 . The use of  claim 66 , wherein the mammal is a pig. 
     
     
         68 . The use of  claim 65  wherein the animal enzyme is derived from a pancreas. 
     
     
         69 . The use of  claim 56 , wherein the compositions comprising digestive enzymes are manufactured using a technology selected from the group consisting of enteric coating, lipid encapsulation, direct compression, dry granulation, wet granulation, and a combination thereof. 
     
     
         70 . The use of  claim 69 , wherein the composition is formulated for oral administration. 
     
     
         71 . The use of  claim 69 , wherein said composition is a dosage formulation selected from the group consisting of pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, and a combination thereof. 
     
     
         72 . The use of  claim 63 , wherein the total amount of protease in said composition is from about 10,000 to about 1,500,000 U.S.P. units/dose. 
     
     
         73 . The use of  claim 72 , wherein the total amount of protease in said composition is about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 25,000; about 30,000; about 40,000; about 50,000; about 65,000; about 75,000; about 100,000; about 140,000; about 140,400; about 150,000; about 200,000; about 250,000; about 300,000; about 350,000; about 400,000; about 450,000; about 465,000; about 500,000; about 550,000; about 600,000; about 650,000; about 700,000; about 750,000; about 800,000; about 850,000; about 900,000; about 950,000; about 1,000,000; about 1,050,000; about 1,100,000; about 1,150,000; about 1,200,000; about 1,250,000; about 1,300,000; about 1,350,000; about 1,400,000; about 1,450,000; or about 1,500,000; about 1,200,000; about 1,250,000; about 1,300,000; about 1,350,000; about 1,400,000; about 1,450,000; or about 1,500,000 U.S.P. units/dose. 
     
     
         74 . The use of  claim 63 , wherein the total amount of amylase in said composition is from about 1,000 to about 15,000,000 U.S.P. units/dose. 
     
     
         75 . The use of  claim 74 , wherein the total amount of amylase in said composition is about 1,000; about 3,000; about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 25,000; about 30,000; about 40,000; about 50,000; about 65,000; about 75,000; about 100,000; about 144,000; about 500,000; about 1,000,000; about 2,000,000; about 3,000,000; about 4,000,000; about 5,000,000; about 6,000,000; about 7,000,000; about 8,000,000; about 9,000,000; about 10,000,000; about 11,000,000; about 12,000,000; about 13,000,000; about 14,000,000; and about 15,000,000 U.S.P. units/dose. 
     
     
         76 . The use of  claim 63 , wherein the total amount of lipase in said composition is from about 1,500 to about 282,000 U.S.P. units/dose. 
     
     
         77 . The use of  claim 76 , wherein the total amount of lipase in said composition is about 1,500; about 1,880; about 2,000; about 3,000; about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 20,000; about 23,000; about 23,040; about 25,000; about 25,000; about 30,000; about 40,000; about 50,000; about 65,000; about 75,000; about 100,000; about 125,000; about 150,000; about 200,000; about 250,000; and about 282,000 U.S.P. units/dose. 
     
     
         78 . The use of  claim 56 , wherein said one or more symptoms are reduced in severity or duration by about 2%, about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 90%, about 95%, or about 100%. 
     
     
         79 . Use of a composition of any one of  claims 33 - 55  in the formulation of a medicament for the treatment of one or more symptoms of schizophrenia or psychosis. 
     
     
         80 . The use of  claim 79 , wherein the one or more symptoms are selected from the group consisting of one or more positive symptoms, one or more negative symptoms, one or more symptoms of cognitive impairment, and a combination thereof. 
     
     
         81 . The use of  claim 80 , wherein the one or more positive comprise hallucinations, delusions, disorganized thought, disorganized speech, movement disorders, bizarre behavior, or a combination thereof. 
     
     
         82 . The use of  claim 80 , wherein the one or more negative symptoms comprise loss of motivation, restricted range of emotional experience and expression, reduced hedonic capacity, affective flattening, alogia, avolition, or a combination thereof. 
     
     
         83 . The use of  claim 80 , wherein the one or more symptoms of cognitive impairment comprise poor executive function, inability to use learned information, difficulty paying attention and/or focusing, or a combination thereof. 
     
     
         84 . The use of  claim 79 , wherein the composition comprising digestive enzymes comprises amylases, lipases, proteases, or a combination thereof. 
     
     
         85 . The use of  claim 84 , wherein the composition further comprises chymotrypsin, trypsin, pancreatin, papain, and a combination thereof. 
     
     
         86 . The use of  claim 79 , wherein the digestive enzymes are derived from a source selected from the group consisting of animal enzymes, plant enzymes, synthetic enzymes, and a combination thereof. 
     
     
         87 . The use of  claim 86 , wherein the animal enzyme is derived from a mammal. 
     
     
         88 . The use of  claim 87 , wherein the mammal is a pig. 
     
     
         89 . The use of  claim 86 , wherein the animal enzyme is derived from a pancreas. 
     
     
         90 . The use of  claim 79 , wherein the compositions comprising digestive enzymes are manufactured using a technology selected from the group consisting of enteric coating, lipid encapsulation, direct compression, dry granulation, wet granulation, and a combination thereof. 
     
     
         91 . The use of  claim 90 , wherein the composition is administered orally. 
     
     
         92 . The use of  claim 90 , wherein said composition is a dosage formulation selected from the group consisting of pills, tablets, capsules, microcapsules, mini-capsules, time released capsules, mini-tabs, sprinkles, and a combination thereof. 
     
     
         93 . The use of  claim 84 , wherein the total amount of protease in said composition is from about 10,000 to about 1,500,000 U.S.P. units/dose. 
     
     
         94 . The use of  claim 93 , wherein the total amount of protease in said composition is about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 25,000; about 30,000; about 40,000; about 50,000; about 65,000; about 75,000; about 100,000; about 140,000; about 140,400; about 150,000; about 200,000; about 250,000; about 300,000; about 350,000; about 400,000; about 450,000; about 465,000; about 500,000; about 550,000; about 600,000; about 650,000; about 700,000; about 750,000; about 800,000; about 850,000; about 900,000; about 950,000; about 1,000,000; about 1,050,000; about 1,100,000; about 1,150,000; about 1,200,000; about 1,250,000; about 1,300,000; about 1,350,000; about 1,400,000; about 1,450,000; or about 1,500,000; about 1,200,000; about 1,250,000; about 1,300,000; about 1,350,000; about 1,400,000; about 1,450,000; or about 1,500,000 U.S.P. units/dose. 
     
     
         95 . The use of  claim 84 , wherein the total amount of amylase in said composition is from about 1,000 to about 15,000,000 U.S.P. units/dose. 
     
     
         96 . The use of  claim 95 , wherein the total amount of amylase in said composition is about 1,000; about 3,000; about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 25,000; about 30,000; about 40,000; about 50,000; about 65,000; about 75,000; about 100,000; about 144,000; about 500,000; about 1,000,000; about 2,000,000; about 3,000,000; about 4,000,000; about 5,000,000; about 6,000,000; about 7,000,000; about 8,000,000; about 9,000,000; about 10,000,000; about 11,000,000; about 12,000,000; about 13,000,000; about 14,000,000; and about 15,000,000 U.S.P. units/dose. 
     
     
         97 . The use of  claim 84 , wherein the total amount of lipase in said composition is from about 1,500 to about 282,000 U.S.P. units/dose. 
     
     
         98 . The use of  claim 97 , wherein the total amount of lipase in said composition is about 1,500; about 1,880; about 2,000; about 3,000; about 5,000; about 7,500; about 10,000; about 15,000; about 20,000; about 20,000; about 23,000; about 23,040; about 25,000; about 25,000; about 30,000; about 40,000; about 50,000; about 65,000; about 75,000; about 100,000; about 125,000; about 150,000; about 200,000; about 250,000; and about 282,000 U.S.P. units/dose. 
     
     
         99 . The use of  claim 79 , wherein said one or more symptoms are reduced in severity or duration by about 2%, about 5%, about 10%, about 15%, about 20%, about 25%, about 30%, about 35%, about 40%, about 45%, about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 90%, about 95%, or about 100%.