The present disclosure provides methods of
dose initiation of
aripiprazole therapy. In particular, the present disclosure relates to the use of
aripiprazole for the preparation of an
aripiprazole intramuscular (IM) depot formulation for use in a
dose initiation method for aripiprazole treatment of a patient in need thereof wherein the aripiprazole intramuscular (IM) depot formulation comprises 300 mg or 400 mg of aripiprazole, the method comprises: administering to the patient two separate injections of the aripiprazole intramuscular (IM) depot formulation at separate injection sites selected from the group consisting of the gluteus site, the deltoid site, and the gluteus site and the deltoid site, wherein each injection comprises 300 mg or 400 mg of aripiprazole; and administering a single
dose of oral aripiprazole, wherein the step of administering two separate injections and oral single dose is performed on the first day of the treatment. The present invention provides the following advantages: (1) the therapeutic aripiprazole
plasma concentration is achieved on the first day of treatment; (2) the consistent clinical effect in the whole administration interval is supported; (3) producing aripiprazole
plasma concentrations similar to the currently approved (traditional) starting
regimen, thus producing similar safety profiles; and (4) providing a new onset selection that eliminates the need for supplementation of 14-day
oral tablets, potentially reducing compliance-related treatment insufficiency during the onset phase of treatment.