is a standard measure that is an 11-item rating scale used by healthcare providers to assess the scope and severity of manic symptoms.
After two weeks, patients who demonstrated an inadequate response (Y-MRS total score 16 and 35% improvement on the Y-MRS total score) to lithium or valproate alone received ABILIFY as adjunctive therapy with a starting dose of 15 mg/day, and the option to increase to 30 mg/day or reduce to 10 mg/day as early as day four.
The Y-MRS, or Young-Mania Rating Scale, and the MADRS, or Montgomery-sberg Depression Rating Scale, are diagnostic questionnaires used to measure the severity of manic and depressive episodes, respectively.
The key outcome measures included change from baseline in the Y-MRS
Total Score response rate (based on greater than/equal to 50% decreases in Y-MRS
) and remission rate (based on Y-MRS
Total Score less than/equal to 12).
Patients demonstrating an inadequate response (Y-MRS
Total Score greater than or equal to 16 and less than or equal to 25% improvement on the Y-MRS
Total Score) to lithium or valproate were randomized to receive either adjunctive ABILIFY (15 mg/day or an increase to 30 mg/day as early as day seven based on clinical response) or adjunctive placebo.
In the active-controlled study, ABILIFY demonstrated comparable symptom improvement (as measured by improvement in Y-MRS
score) and a significantly higher response rate compared to that of haloperidol (50% vs.
Response rate was determined by the percentage of patients who exhibited a 50% or greater improvement from baseline on the Y-MRS
score and who were still on treatment at Week 12.