ACCELERATED RECOVERY FROM ISCHEMIC STROKE WITH INDELOXAZINE HYDROCHLORIDE - RESULTS OF A DOUBLE-MASKED CLINICAL-STUDY IN KOREA

The efficacy and tolerability of indeloxazine hydrochloride, a new non anticholinergic antidepressant, were evaluated in 65 Korean patients w ith ischemic stroke 1 to 3 months after the occurrence of stroke. Thir ty-two patients received an oral dose of indeloxazine 20 mg, three tim es daily, for 3 months, whereas 33 patients (the control group) receiv ed the same dosing regimen using identical placebo tablets, Three mont hs after administering drug, both groups shelved significant improveme nt in Mini Mental State Examination scares, subjective symptoms, neuro logic symptoms, and activities of daily living scores compared with ba seline. Thus the disturbances observed after stroke were gradually eli minated spontaneously, However, a months after drug administration, to tal mental symptoms including emotional disturbance, spontaneity, impa ired intelligence and mental function, abnormal behavior, and sleep di sturbance were significantly improved in the indeloxazine-treated grou p, but not in the placebo-treated group compared with baseline, In par ticular, a significant difference was seen in improvement in mental sy mptoms such as spontaneity and impaired intelligence and mental functi on between the two groups. Two indeloxazine- and three placebo-treated patients withdrew from the study because of adverse effects, although objective evidence of adverse effects was lacking, These results sugg est that indeloxazine may help accelerate the rehabilitation of patien ts with ischemic stroke by improving mental symptoms.