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 nonanticholinergic antidepressant, were evaluated in 65 Korean patients with ischemic stroke 1 to 3 months after the occurrence of stroke. Thirty-two patients received an oral dose of indeloxazine 20 mg, three times daily, for 3 months, whereas 33 patients (the control group) received the same dosing regimen using identical placebo tablets, Three months after administering drug, both groups shelved significant improvement in Mini Mental State Examination scares, subjective symptoms, neurologic symptoms, and activities of daily living scores compared with baseline. Thus the disturbances observed after stroke were gradually eliminated spontaneously, However, a months after drug administration, total mental symptoms including emotional disturbance, spontaneity, impaired intelligence and mental function, abnormal behavior, and sleep disturbance were significantly improved in the indeloxazine-treated group, but not in the placebo-treated group compared with baseline, In particular, a significant difference was seen in improvement in mental symptoms such as spontaneity and impaired intelligence and mental function 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 suggest that indeloxazine may help accelerate the rehabilitation of patients with ischemic stroke by improving mental symptoms.