IDRA-21 as a nootropic drug for the treatment of mental illness and improvement of cognitive functions. In experimental studies, the effectiveness of IDRA-21 in animals with models of depression, stress and anxiety is shown. IDRA-21 clinical study was conducted in accordance with the Eureppean Medicines Agency – EMA requirements and included the following steps:
1) demonstration of efficacy relative to placebo;
2) comparison of efficacy with that of others used in the clinic nootropic drugs;
3) demonstrating the effectiveness of Pi (for the relapse prevention);
4) demonstration of a favorable benefit / risk ratio.
At the first stage, 6 short-term randomized, placebo-controlled studies were performed. The remarkable superiority of IDRA-21 over placebo is shown in 3 of them. Along with nootropic effect, the presence of anxiolytic action in IDRA-21 was confirmed.
In 2 of the 3 studies, where there was no statistically significant difference between IDRA-21 and placebo, similar results were obtained for the active reference drugs (piracetam and nootropil), which is probably due to the unusually high frequency of responders in the placebo group (47- 58%). This problem is often encountered in the study of nootropics, as evidenced by the results of a meta-analysis that showed the ineffectiveness of the most commonly used medications in patients with mild and moderate depression. The positive effect of placebo in a significant number of subjects in the study, which is not the case in real medical practice.
To minimize the risk of adverse effect of placebo on the results of studies of IDRA-21, the criteria for including patients were significantly tightened; in subsequent studies included only patients with moderate and severe depression. As a result of 2 key, IDRA-21 was used at a daily dose of 25-50 mg, it was unequivocally demonstrated to be effective (49.1 and 54.3%) compared with placebo, despite the high response rate in the The latter group (approximately 35%).
In other phase III studies, IDRA-21 in a dose of 25-50 mg was compared with others used nootropics – piracetam (50-100 mg) and nootropil (75-150 mg). IDRA-21 is shown at least comparable to these drugs effectiveness. In the HAM-D and CGI-I scores (improvement), which, according to the protocols, were secondary endpoints in these studies, IDRA-21 was superior in performance to both comparators.
The efficacy of IDRA-21 has been demonstrated both in general in all participants, and in patients with the most severe depression. IDRA-21 in comparison groups. Another advantage of IDRA-21 over other drugs was a rapid therapeutic effect development (1-2 weeks). In particular, the advantage of IDRA-21 was the observation of an IDRA-21 before nootropil in improving the falling asleep process and the sleep quality, from the first week of treatment and for 6 weeks, was demonstrated using a special questionnaire for assessing sleep. The results of a meta-analysis of 6 short-term pre-registration studies also showed a statistically significant advantage of IDRA-21 before placebo and became the basis for resolving its medical application in the European Union and United States. In another meta-analysis, which included only 3 studies with positive results, it was shown that the superiority of IDRA-21 over placebo increases with the severity of depression. This allowed us to conclude that the drug is particularly effective in patients with weakened cognitive functions.
The results of a recently published 8-week randomized double-blind study, IDRA-21 is superior in effectiveness to fluoxetine. However, as indicated above, with the correct methodology of the study, IDRA-21 demonstrates the efficacy in patients with milder forms of the disease. IDRA-21 efficacy at doses of 25 and
50 mg/day for both severe and moderate depression. If you’re looking for the best place to buy IDRA-21 nootropic drug online, visit RC’s online store to place an order.
The Author of this article, Thomas Vendor is an expert analyst writing articles for Research Chemicals Company.