Abstract
PurposeA substantial proportion of patients with major depressive disorder (MDD) does not respond or cannot tolerate to currently available treatments. This study was to assess the safety and tolerability of Remote Limb Ischemic Preconditioning (RLIPC) as an adjunctive therapy in patients with MDD.Patients and MethodsEnrolled patients underwent RLIPC, five cycles of simultaneous bilateral arm ischemia, 5 min and followed by reperfusion of each cycle, and once daily for eight consecutive weeks. Depression and anxiety severity, and quality of life were assessed every 2 weeks. Descriptive analysis was used for safety and tolerability data.ResultsThirty-seven participants completed at least one RLIPC. Twenty-four of them (64.9%) completed the study. Twelve patients prematurely discontinued the study due to poor adherence, and one due to a mild side effect. The changes in HRSD-17, GAD-7 and QOL-6 total scores from baseline to the endpoint were significant from the end of second week treatment onwards. The responder and remission rates were 59.46% (22/37) and 54.05% (20/37) at the endpoint, respectively.ConclusionRLIPC was safe and well tolerated, and may be effective in reducing depressive symptoms in patients with MDD. Large studies are warranted to test its efficacy and safety as monotherapy or adjunctive therapy in the treatment of MDD.
Highlights
Major depressive disorder (MDD) is one of the most common mental disorders in the general population and a major public health problem across the world
We conducted a proof of concept study to assess the safety and tolerability of Remote Limb Ischemic Preconditioning (RLIPC) as an adjunctive therapy in patients with MDD who were treated with an antidepressant for a current depressive episode
Patients who met the following criteria were enrolled into the study: 1) age of 18–65 years old; 2) diagnosed with MDD according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5); 3) a score of ≥14 on the 17- item Hamilton Rating Scale for Depression (HRSD-17) at the screening visit; 4) had the capacity for the informed consent for the study
Summary
Enrolled patients underwent RLIPC, five cycles of simultaneous bilateral arm ischemia, 5 min and followed by reperfusion of each cycle, and once daily for eight consecutive weeks.
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