Pawel Mierzejewski
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
To be updated.
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