Method of treating metabolic disorders and depression with dopamine receptor agonists

Abstract

This invention relates to methods and formulations for treating metabolic disorders and depression. In some embodiments, the methods comprise administering a dopamine receptor agonist and an anti-depressant.

1 . A method of treating a metabolic disorder and depression comprising administering to a patient in need thereof a therapeutically effective amount of one or more dopamine receptor agonists. 
   
   
       2 . The method of  claim 1 , wherein the dopamine receptor agonist is administered daily at a pre-determined time of day. 
   
   
       3 . The method of  claim 2 , wherein the pre-determined time of day is in the morning. 
   
   
       4 . The method of  claim 3 , wherein the pre-determined time of day is upon waking. 
   
   
       5 . The method of  claim 4 , wherein the metabolic disorder is Type 2 diabetes and/or cardiovascular disease. 
   
   
       6 . The method of  claim 1 , wherein the dopamine receptor agonist is at least one of a dopamine D1 receptor agonist or a dopamine D2 receptor agonist. 
   
   
       7 . The method of  claim 1 , wherein the dopamine receptor agonist is an ergot-related compound. 
   
   
       8 . The method of  claim 1  wherein the dopamine receptor agonist is selected from the group consisting of lisuride, terguride, dihydroergotoxine (hydergine), and bromocriptine. 
   
   
       9 . A method of treating a metabolic disorder and depression comprising administering to a patient in need thereof a therapeutically effective combination of a dopamine receptor agonist and an anti-depressant, wherein the dopamine receptor agonist is administered at a first predetermined time of day in the morning and the anti-depressant is administered at a second predetermined time of day in the evening. 
   
   
       10 . The method of  claim 9 , wherein the anti-depressant is a serotonin enhancer or prolactin enhancer. 
   
   
       11 . The method of  claim 9 , wherein the first pre-determined time of day is upon waking. 
   
   
       12 . The method of  claim 11 , wherein the first pre-determined time of day is within 0400 to 1200 hours. 
   
   
       13 . The method of  claim 9 , wherein the second pre-determined time of day is within 1-2 hours prior to bedtime. 
   
   
       14 . The method of  claim 13 , wherein the second pre-determined time of day is within 2000 to 2400 hours. 
   
   
       15 . The method of any one of  claims 9 , wherein the anti-depressant is administered in a sub-threshold amount. 
   
   
       16 . A dosage form comprising a first active agent and a second active agent, wherein said first active agent is an anti-depressant, said second active agent is a dopamine agonist, said first active agent is substantially released within 2 hours following administration of said dosage form and said second active agent is released substantially within the period within 2 hours of waking when said dosage is administered at bedtime.