Objectives: Endoxifen is a protein kinase C inhibitor. The objective of the present phase III study was to demonstrate the safety and efficacy of endoxifen in treating bipolar I disorder (BPD I) patients. Methods:A multicenter, double-blind, active-controlled study was conducted using a daily dose of 8 mg endoxifen compared to 1000 mg divalproex, the current standard treatment, in patients with BPD I acute manic episodes with/without How to cite this article: Ahmad A, Sheikh S, Khan MA, et al.Endoxifen: A new, protein kinase C inhibitor to treat acute and mixed mania associated with bipolar I disorder. Bipolar
Background:Informed consent forms are required in all clinical trials which are approved by an independent Ethics Committee before practical use in the trials. However, how much the average subject actually understands of the information contained in these informed consent forms is uncertain.Aim:In a cross sectional study, the translated informed consent forms used in psychiatric clinical trials were assessed with respect to their ease of readability.Materials and Methods:We analyzed 30 informed consent forms translated from English to Hindi used in multinational and multicentre psychiatric clinical trials sponsored by different sponsors. We examined consent forms for readability scores and factors that might relate to readability.Results:The mean readability score for the informed consent forms, determined by the Flesch-Kincaid Grade Level Index (FKGL) was grade levels of 13.66. The ease of readability assessed by the Flesch Reading Ease Score (FRES) was 46.08 suggesting significant complexity of the texts. These values carry even more significance when the average years of schooling for India as a whole are 6.2 years.Conclusion:Our results show that the most informed consent forms were too complex to understand by an average adult subject. We suggest reducing this complexity and increasing the ease of readability so those average subjects receive the intended information as exactly as it could be. This can be achieved by few simple measures like improving the deficiencies in translation processes, encouraging the investigators to participate while preparing these forms, and enhanced understanding of the site specific requirements, namely culture, language (dialect), general literacy rate, etc.
About 30 to 46% of patients with major depressive disorder (MDD) fail to fully respond to initial antidepressants. Treatment-resistant depression (TRD) is a severely disabling disorder with no proven treatment options; novel treatment methods like rTMS can be used as augmentation to ongoing pharmacotherapy or as a solitary method of treatment. To evaluate the utility of repetitive transcranial magnetic stimulation as an augmenting method in TRD. In an open-label study, 21 patients with DSM-IV MDD without psychotic features who had failed to respond to an adequate trial of at least 2 antidepressants were given rTMS therapy for 4 weeks, keeping the dose of pre-existing antidepressants unchanged. High-frequency (10 Hz) stimulations were delivered over left dorsolateral prefrontal cortex at intensity of 110% of patient's motor threshold. Treatment response was defined as a reduction in score on the Hamilton Rating Scale for Depression (HAM-D) from baseline to end of treatment. Secondary efficacy measures included scores on the Clinical Global Impressions-Change and -Severity scales. At the end of 4 weeks, 19 patients completed the 4-week study and were assessed. In ITT analysis, the mean HAM-D17 scores were reduced from 30.80±5.00 to 19.00±6.37 (t=8.27, P<0.001). Only four patients reported headache, but there was no discontinuation due to adverse effects. The study indicates the potential utility of rTMS as an augmenting agent in TRD. Adequately powered, randomized controlled trials are necessary to evaluate the role of rTMS in TRD.
Background:About 30–46% of patients with major depressive disorder (MDD) fail to fully respond to initial antidepressants. Treatment-resistant depression is a severely disabling disorder with no proven treatment options; novel treatment methods, such as repetitive transcranial magnetic stimulation (rTMS) can be used as augmentation to ongoing pharmacotherapy or as a solitary method of treatment.Aim:To evaluate the utility of rTMS as an augmenting method in treatment-resistant depression.Materials and Methods:In an open-label study, 21 patients with DSM-IV MDD without psychotic features who had failed to respond to an adequate trial of at least 2 antidepressants were given rTMS therapy for 4 weeks keeping the dose of pre-existing antidepressants unchanged. High-frequency (10 Hz) stimulations were delivered over left dorsolateral prefrontal cortex at an intensity of 110% of the patient's motor threshold. Treatment response was defined as a reduction in score on the Hamilton Rating Scale for Depression (HAM-D) from baseline to end of treatment. Secondary efficacy measures included scores on the Clinical Global Impressions-Change and -Severity scales.Results:At the end of 4 weeks, 19 patients completed the 4 weeks study and were assessed. In ITT analysis the mean HAM-D17 scores were reduced from 30.80±5.00 to 19.00±6.37 (t=8.27, P<0.001). Only 4 patients reported headache but there was no discontinuation due to adverse effects.Conclusions:The study indicates the potential utility of rTMS as an augmenting agent in treatment-resistant depression. Adequately powered, randomized controlled trials are necessary to evaluate the role of rTMS in treatment-resistant depression.
We reviewed Ghosh et al. 1 letter based on our active-controlled, double-blind, and randomized trial 2 that demonstrated the therapeutic benefit of Endoxifen in patients with bipolar I disorder. The author's reservations about the sample size estimation, statistical analysis, and missing data handling on the published article are unfounded. The clinical study design, conduct, and analysis were done under required regulatory and Good Clinical Practice guidelines. The non-inferiority margin was chosen based on consideration of our prior study. 3
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