Clinical trial on Neurapas versus placebo in patients with mild to moderate depressive symptoms: a placebo-controlled, randomised double-blind studyPhase IV: Clinical trial

Author(s): GESSNER, B., SCHAITON, W., WELLEMS, M.

Abstract: In a double-blind, placebo controlled clinical trial, the efficacy and tolerance of 8 weeks" treatment with Neurapas tablets for moderate to severe depressive symptoms was investigated in 30 patients per group. The basic parameters from the doctor's and patients' assessments of therapeutic progress were used for the purposes of analysis. Tolerance was determined on the basis of adverse drug reactions (ADRs), dose changes and drop-outs as well as general clinical findings, the vital parameters blood pressure and pulse and laboratory tests.Descriptive statistical analysis revealed an extensive improvement in depressive symptoms over the period of treatment with Neurapas tablets. Although the situation also improved on placebo, the difference from placebo was pronounced to varying degrees in favour of Neurapas tablets according to all scales, even after taking into account the pretreatment situation. It was not the size of the difference which mattered but the fact that the results on all the scales tended in the same direction.In terms of the change in condition based on the Clinical Global Impression (CGI) and the DSI index from the Depression Status Inventory (DSI), the difference in all the measurements was validated at a significance level of p < 0.05. Patient completion forms underlined the efficacy of the active drug in comparison with placebo. The sets of questions designed to assess the efficacy of the medication were clearly answered in favour of Neurapas tablets. The vital parameters blood pressure and pulse as well as the laboratory parameters remained within the normal range during treatment with Neurapas tablet or placebo. There were no systematic changes. There were no serious side-effects or drop-outs in the group receiving Neurapas tablets.The double-blind design excludes the possibility of any subjective influence on individual measurements in favour of either of the medications. The evidence of efficacy obtained from the trial should be seen as valid since the results on several scales as well as the doctor's and patients' assessments coincide.The effects of Neurapas tablets compared with placebo in the treatment of moderate to severe depressive symptoms, which were previously observed in an open treatment study, are proved by the present trial and the efficacy of this treatment versus placebo is validated under double-blind, controlled study conditions.

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