Gaboxadol for reducing risk of suicide and rapid relief of depression

Abstract

Methods and compositions are disclosed for rapidly reducing the risk of suicide in patients suffering from acute suicidality and rapidly relieving mood symptoms in major depression and treatment-resistant depression using a novel therapeutic regimen comprising a single or intermittent administration of a high dose of gaboxadol, or a pharmaceutically acceptable salt thereof, to the subject in need thereof.

1 - 24 . (canceled) 
     
     
         25 . A method of treating a human patient with depression, said method comprising the following steps in the order stated:
 (a) orally administering to the human patient gaboxadol or a pharmaceutically acceptable salt thereof, followed by a wash-out period of 3 or more days during which no gaboxadol or pharmaceutically acceptable salt thereof is administered to the patient; and   (b) orally administering gaboxadol or a pharmaceutically acceptable salt thereof after said wash-out period.   
     
     
         26 . The method of  claim 25 , wherein the amount of gaboxadol or pharmaceutically acceptable salt thereof administered in step (a) is in a range of about 50 mg to about 150 mg. 
     
     
         27 . The method of  claim 25 , where the wash-out period is 3, 4, 5, 6, or 7 days. 
     
     
         28 . The method of  claim 25 , wherein the human patient has major depressive disorder. 
     
     
         29 . The method of  claim 25 , wherein the human patient has treatment-resistant depression. 
     
     
         30 . The method of  claim 25 , wherein the method further comprises, within 12 hours prior to step (a), an initial step of administering gaboxadol or a pharmaceutically acceptable salt thereof. 
     
     
         31 . The method of  claim 30 , wherein the human patient has major depressive disorder. 
     
     
         32 . The method of  claim 30 , wherein the human patient has treatment-resistant depression. 
     
     
         33 . The method of  claim 30 , wherein the initial step of administering gaboxadol or a pharmaceutically acceptable salt thereof is within 6 hours prior to step (a). 
     
     
         34 . The method of  claim 33 , wherein the method further comprises, after said initial step and before step (a), a step of performing a clinical test that demonstrates that the patient had an insufficient response to said initial step. 
     
     
         35 . The method of  claim 34 , wherein the human patient has major depressive disorder. 
     
     
         36 . The method of  claim 34 , wherein the human patient has treatment-resistant depression. 
     
     
         37 . The method of  claim 34 , wherein the clinical test is a neurological test that the patient is subjected to within 180 minutes after said initial step. 
     
     
         38 . The method of  claim 37 , wherein the neurological test is electroencephalography, and wherein an insufficient response is an electroencephalogram power density increase of less than 30% over a baseline measurement recorded prior to said initial step. 
     
     
         39 . The method of  claim 38 , wherein the electroencephalogram power density is recorded at a sampling rate of 0.25 Hz to about 8.0 Hz. 
     
     
         40 . The method of  claim 38 , wherein the electroencephalogram power density is recorded at a sampling rate of 4.75 Hz to about 8.0 Hz. 
     
     
         41 . The method of  claim 37 , wherein the neurological test is whole head magnetoencephalography, and wherein the insufficient response is characterized by a planar gradiometer increase of less than +3 in a combined delta, theta, and alpha activity. 
     
     
         42 . The method of  claim 25 , wherein step a) further comprises administering ketamine to the patient. 
     
     
         43 . The method of  claim 26 , wherein the human patient has major depressive disorder. 
     
     
         44 . The method of  claim 26 , wherein the human patient has treatment-resistant depression. 
     
     
         45 . A method of reducing risk of suicide in a human patient, said method comprising the following steps in the order stated:
 (a) orally administering to the patient gaboxadol or a pharmaceutically acceptable salt thereof, followed by a wash-out period of 3 or more days during which no gaboxadol or pharmaceutically acceptable salt thereof is administered to the patient; and   (b) orally administering gaboxadol or a pharmaceutically acceptable salt thereof after said wash-out period.   
     
     
         46 . The method of  claim 45 , wherein the amount of gaboxadol or pharmaceutically acceptable salt thereof administered in step (a) is in a range of about 50 mg to about 150 mg. 
     
     
         47 . The method of  claim 45 , wherein the method further comprises, within 12 hours prior to step (a), an initial step of administering gaboxadol or a pharmaceutically acceptable salt thereof. 
     
     
         48 . The method of  claim 47 , wherein the method further comprises, after said initial step and before step (a), a step of performing a clinical test that demonstrates that the patient had an insufficient response to said initial step.