Combination Therapy for Bipolar Disorder

Abstract

Treatment regimens for mood disorders that include administration of buprenorphine, alone or in combination with additional pharmacological agents are described. Specifically, treatment regimens that alleviate racing thoughts associated with bipolar disorder, and pharmaceutical compositions and kits for use therein are described. Dosing regimens, compositions, and kits including buprenorphine for treating mania associated with opioid withdrawal are also described.

1 - 29 . (canceled) 
     
     
         30 . A composition comprising (i) buprenorphine or a pharmaceutically acceptable salt thereof and (ii) a second active agent in a single dosage form, wherein the second active agent comprises an antipsychotic agent, an atypical antipsychotic agent, an antiepileptic agent, lithium, a P-450 CYP3A4 inhibitor, a P-450 CYP2D6 inhibitor, salts and acids thereof, and combinations thereof. 
     
     
         31 - 35 . (canceled) 
     
     
         36 . The composition of  claim 30 , wherein the second active agent comprises an atypical antipsychotic. 
     
     
         37 . The composition of  claim 36 , wherein the atypical antipsychotic is selected from the group consisting of aripriprazole, arisuipride, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone, and combinations thereof. 
     
     
         38 - 51 . (canceled) 
     
     
         52 . A method for treating a bipolar condition and subtypes thereof in a subject, the subject experiencing at least one episode of racing thoughts, comprising administering buprenorphine or a pharmaceutically acceptable salt thereof to the subject to alleviate the racing thoughts. 
     
     
         53 . The method of  claim 52 , wherein the bipolar condition is bipolar I disorder. 
     
     
         54 . The method of  claim 52 , wherein the bipolar condition is bipolar II disorder. 
     
     
         55 . The method of  claim 52 , wherein the bipolar condition is mixed bipolar disorder. 
     
     
         56 - 59 . (canceled) 
     
     
         60 . The method of  claim 52 , further comprising administering an opioid antagonist. 
     
     
         61 . The method of  claim 60 , wherein the opioid antagonist comprises naloxone. 
     
     
         62 . The method of  claim 61 , wherein the buprenorphine and naloxone are administered together in a unit dose. 
     
     
         63 - 64 . (canceled) 
     
     
         65 . The method of  claim 52 , further comprising administering a second active agent to the subject. 
     
     
         66 . The method of  claim 65 , wherein the second active agent is selected from the group consisting of antipsychotic agents, atypical antipsychotic agents, antiepileptic agents, lithium, and salts and acids thereof. 
     
     
         67 . The method of  claim 66 , wherein the second active agent comprises an atypical antipsychotic agent selected from the group consisting of aripriprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone, arisulpride, and combinations thereof. 
     
     
         68 - 83 . (canceled) 
     
     
         84 . The method of  claim 52 , wherein about 2.0 mg of buprenorphine is administered to the subject. 
     
     
         85 . The method of  claim 52 , wherein about 8.0 mg of buprenorphine is administered to the subject. 
     
     
         86 . A kit for treating a bipolar condition and subtypes thereof comprising: a plurality of buprenorphine dosage forms; at least one second dosage form comprising a second active agent; a housing; and instructions for taking the dosage forms for racing thoughts associated with the depressed phase of the bipolar condition or subtype thereof, and according to a predetermined dosing regimen, wherein the housing is configured to organize the dosage forms according to the predetermined dosing regimen. 
     
     
         87 - 94 . (canceled) 
     
     
         95 . The kit of  claim 86 , wherein the second active agent is selected from the group consisting of antipsychotic agents, atypical antipsychotic agents, antiepileptic agents, lithium, and salts and acids thereof. 
     
     
         96 . The kit of  claim 95 , wherein the second active agent comprises an atypical antipsychotic agent selected from the group consisting of aripriprazole, olanzapine, paliperidone, quetiapine, risperidone, ziprasidone, arisulpride, and combinations thereof. 
     
     
         97 . (canceled) 
     
     
         98 . The kit of  claim 86 , comprising a plurality of second dosage forms. 
     
     
         99 - 123 . (canceled) 
     
     
         124 . The kit of  claim 98 , wherein the housing is configured to organize the buprenorphine dosage forms and second dosage forms into morning dosage forms and evening dosage forms. 
     
     
         125 - 129 . (canceled)