Method for treating post-traumatic stress disorder

Abstract

The present disclosure provides compositions containing ketamine and methods of using those compositions for the treatment of post-traumatic stress disorder. Also provided herein is a pharmaceutical composition that comprises esketamine and a pharmaceutically acceptable carrier, excipient or diluent, for use in treatment of PTSD. In some aspects, the pharmaceutical composition is for intranasal or intravenous administration. In some aspects, the pharmaceutical composition is for use in a method of treating PTSD in a subject. In some aspects, the pharmaceutical composition is for use in a method of treating major depressive disorder in a subject that is co-morbid with the PTSD.

1 . A method of treating post-traumatic stress disorder (PTSD) comprising treating a human individual suffering from PTSD with a therapeutically effective amount of ketamine. 
     
     
         2 . The method of  claim 1 , wherein the effective amount of ketamine is a dose of about 0.01 to about 2.0 mg of ketamine per kilogram of body weight of the patient (mg/kg) to treat the PTSD. 
     
     
         3 . The method of  claim 2 , wherein the dose is about 0.05 to about 0.5 mg/kg of ketamine. 
     
     
         4 . The method of  claim 2 , wherein the dose is less than about 0.5 mg/kg, less that about 0.4 mg/kg or less than about 0.3 mg/kg of ketamine. 
     
     
         5 . The method of  claim 1 , wherein the therapeutically effective amount of ketamine is a sub-anesthetic amount of ketamine for the individual. 
     
     
         6 . The method of  claim 1 , wherein the therapeutically effective amount of ketamine is a sub-analgesic amount of ketamine for the individual. 
     
     
         7 . The method of  claim 1 , wherein the individual is treated with ketamine via intravenous or intranasal administration. 
     
     
         8 . The method of  claim 7 , wherein the individual is treated intranasally with ketamine, substantially only via the nasal respiratory epithelium, compared to treatment via the nasal olfactory epithelium. 
     
     
         9 . The method of  claim 7 , wherein the individual is treated intranasally with ketamine, substantially only via the nasal olfactory epithelium, compared to treatment via the nasal respiratory epithelium. 
     
     
         10 . The method of  claim 1 , wherein the individual is treated with a single dose of the therapeutically effective amount of ketamine. 
     
     
         11 . The method of  claim 1 , wherein the individual is treated with multiple doses of the therapeutically effective amount of ketamine. 
     
     
         12 . The method of  claim 11 , wherein the individual is treated with at least one dose of the therapeutically effective amount of ketamine per week for a period of two or more weeks. 
     
     
         13 . The method of  claim 1 , further comprising administering a second agent to treat the PTSD. 
     
     
         14 . The method of  claim 8 , wherein the second active agent is an anti-depressant. 
     
     
         15 . The method of  claim 13 , wherein the second active agent is paroxetine, sertraline, lithium, riluzole, prazosin, lamotrigine, or ifenprodil. 
     
     
         16 . The method of  claim 13 , wherein the second agent is used as adjunctive therapy to ketamine treatment. 
     
     
         17 . The method of  claim 13 , wherein the treatment comprises a phase wherein treatment with the second agent takes place after treatment with ketamine as ceased. 
     
     
         18 . The method of  claim 13 , wherein the treatment comprises a phase where treatment with ketamine and treatment with the second agent overlap. 
     
     
         19 . A method of dosing treatment of PTSD with ketamine comprising treating an individual suffering from PTSD with one or more doses comprising a first amount of ketamine to treat PTSD and thereafter treating the individual with one or more doses comprising a second amount of ketamine to maintain treatment of the PTSD, where the second amount of ketamine is lower than the first amount of ketamine. 
     
     
         20 . The method of  claim 19 , wherein the second amount of ketamine is an amount that is at most one-half, one-quarter, or one-tenth the amount of the first amount of ketamine. 
     
     
         21 . The method of  claim 1 , further comprising treating major depressive disorder that is co-morbid with the PTSD. 
     
     
         22 . The method of  claim 1 , wherein the ketamine is administered in a composition comprising a pharmaceutically acceptable carrier, excipient or diluent. 
     
     
         23 . A pharmaceutical composition comprising ketamine and a pharmaceutically acceptable carrier, excipient or diluent, for use in treatment of PTSD. 
     
     
         24 . The pharmaceutical composition of  claim 23  that is for intranasal or intravenous administration. 
     
     
         25 . A method of treating PTSD comprising treating a human individual suffering from PTSD with a therapeutically effective amount of esketamine. 
     
     
         26 . The method of  claim 25 , wherein the esketamine is administered in an amount in the range of from about 0.01 mg/kg to about 1.5 mg/kg. 
     
     
         27 . The method of  claim 25 , wherein the esketamine is administered in an amount in the range of from about 0.01 mg/kg to about 0.75 mg/kg. 
     
     
         28 . The method of  claim 25 , wherein the esketamine is administered in an amount in the range of from about 0.05 mg/kg to about 0.5 mg/kg. 
     
     
         29 . The method of  claim 25 , wherein the esketamine is administered in an amount of about 0.2 mg/kg or in an amount of about 0.4 mg/kg. 
     
     
         30 . The method of  claim 25 , wherein the esketamine is administered intravenously. 
     
     
         31 . The method of  claim 25 , wherein the esketamine is administered intranasally. 
     
     
         32 . The method of  claim 24 , further comprising treating major depressive disorder that is co-morbid with the PTSD. 
     
     
         33 . A pharmaceutical composition comprising esketamine and a pharmaceutically acceptable carrier, excipient or diluent, for use in treatment of PTSD. 
     
     
         34 . The pharmaceutical composition of  claim 33  that is for intranasal or intravenous administration. 
     
     
         35 . The pharmaceutical composition of  claim 33  that is for use in a method of treating PTSD in a subject. 
     
     
         36 . The pharmaceutical composition of  claim 35  that is for use in a method of treating major depressive disorder in a subject that is co-morbid with the PTSD. 
     
     
         37 . The method of  claim 1 , wherein the ketamine is esketamine. 
     
     
         38 . The method of  claim 1 , wherein the total dose of ketamine is about 25 mg. 
     
     
         39 . The method of  claim 1 , wherein the total dose of ketamine is about 50 mg. 
     
     
         40 . The method of  claim 1 , wherein the total dose of ketamine is about 75 mg. 
     
     
         41 . The method of  claim 1 , wherein the total dose of ketamine is about 100 mg. 
     
     
         42 . The method of  claim 1 , wherein the total dose of ketamine is about 1.1 mg/kg. 
     
     
         43 . The method of  claim 38 , wherein the ketamine is esketamine. 
     
     
         44 . A method of treating PTSD comprising administering to a patient in need of such treatment an effective amount for treating PTSD of ketamine or esketamine.