Monika Dominiak
Institute of Psychiatry and Neurology, PolandTitle: Results of interim analysis of a multicentre, randomised, double-blind, placebo-controlled study evaluating the efficacy and safety of low-dose acetylsalicylic acid as an add-on treatment in patients with bipolar disorder
Abstract
Introduction: Bipolar disorder (BD) affects 2-3% of the population. The mechanisms underlying this disorder are still unclear. It has been suggested that they may be linked to disturbances in immune-modulating processes. Studies with low-dose acetylsalicylic acid (ASA) yielded initial encouraging results, but as yet no firm conclusions can be drawn.
Aim: The study aimed at the evaluation the efficacy and safety of low-dose ASA (150mg/d) as an add-on treatment in BD over a period of 12 months.
Materials and methods: The study is conducted at the Institute of Psychiatry and Neurology in Warsaw and three other centres in Poland. A total of 100 patients are planned. Patients are randomly assigned to placebo or ASA 150mg/d groups. The efficacy of therapy is assessed: (1) in the short term (after 2 months) - treatment of a bipolar depression; and (2) in the long term - over a 12-month period. Assessment tools include the Hamilton Depression Scale (HAMD-17, Young Mania Rating Scale (YMRS), General Clinical Impression Scale (CGI-I) and Global Assessment of Functioning (GAF). The safety of the therapy is monitored throughout the study by means of physical parameters and results of laboratory tests.
Results: We present the results of an interim analysis that was performed by an external company, without unblinding the study. Results on a group of 25 patients indicate the safety for an average of six months. The efficacy in the treatment of bipolar depression indicates a beneficial effect of ASA as an add-on treatment as measured by HAMD-17 ( F=9.6 (1,18); p=0.006), as well by GAF (F=10.9 (1,18); p=0.003). Evaluation of the long-term efficacy of ASA will be performed after another 6 months.
Conclusions: Preliminary results indicate that ASA 150mg/d as an add-on treatment is effective in both reducing depressive symptoms and improving overall functioning. Further research is needed to assess its efficacy and safety in long-term use.
Biography
Monika Dominiak – MD, PhD, MBA. Assistant Professor in the Department of Pharmacology at the Institute of Psychiatry and Neurology in Warsaw, Poland. Member of Polish Psychiatric Association. Principal investigator in project financed by Polish Medical Research Agency “A multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of low-dose acetylsalicylic acid as an add-on treatment to standard therapy in patients with bipolar affective disorder”. Research interests include diagnosis and treatment of affective disorders and the application of new technologies in psychiatry. Author of dozens of publications that has been cited over 300 times, her total impact factor over 100, and publication h-index is 10.
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