Intranasal administration of ketamine to treat depression

Abstract

Methods and compositions for the treatment of treatment-resistant depression are described. More specifically, the invention demonstrates that intranasal administration of ketamine is effective to ameliorate the symptoms of depression in a patient who has not responded to an adequate trial of one antidepressant in the current episode and has recurrent or chronic depressive symptoms (>2 years).

1 .- 56 . (canceled) 
     
     
         57 . Method for treating a patient afflicted with a peak episode of extreme Major Depressive Disorder (MDD) which comprises intranasally administering to the patient an effective amount for alleviating said peak episode of MDD of an intra-nasal composition consisting of (2-(2-chlorophenyl)-2-(methylamino-cyclohexanone) and one or more pharmaceutically acceptable excipients and, further administering a second composition containing a conventional pharmaceutical antidepressant agent. 
     
     
         58 . The method of  claim 57  wherein the patient's symptoms of the peak episode of extreme Major Depressive Disorder (MDD) are alleviated within hours after intranasal administration. 
     
     
         59 . The method of  claim 58  wherein the patient's symptoms of the peak episode of extreme Major Depressive Disorder (MDD) are alleviated within 2 hours after intranasal administration. 
     
     
         60 . The method of  claim 57 , which comprises intranasally administering between about 0.01 and 3.0 mg/kg of body weight of (2-(2-chlorophenyl)-2(methylamino-cyclohexanone). 
     
     
         61 . The method of  claim 60  which comprises intranasally administering between about 0.01 and 1.0 mg/kg of body weight of (2-(2-chlorophenyl)-2 (methylamino-cyclohexanone). 
     
     
         62 . The method of  claim 57  wherein the conventional antidepressant is a member selected from the group consisting of lithium, a pharmaceutical antidepressant, an anticonvulsant, a mood stabilizer, an antipsychotic agent and a benzodiazepine. 
     
     
         63 . The method of  claim 57  wherein the conventional antidepressant is a member selected from the group consisting of a biogenic amine, a non-selective reuptake inhibitor, a serotonin selective reuptake inhibitor, a monoamine oxidase inhibitor and an atypical antidepressant. 
     
     
         64 . The method of  claim 63  wherein the serotonin selective reuptake inhibitor comprises fluoxetine. 
     
     
         65 . The method of  claim 57 , which comprises administering a single dose of (2-(2-chlorophenyl)-2(methylamino-cyclohexanone). 
     
     
         66 . The method of  claim 57  wherein the (2-(2-chlorophenyl)-2(methylamino-cyclohexanone) is administered with an inhaler. 
     
     
         67 . The method of  claim 66  wherein the intra-nasal composition is administered as a spray. 
     
     
         68 . The method of  claim 57 , which comprises administering multiple doses of the (2-(2-chlorophenyl)-2(methylamino-cyclohexanone).