EVALUATION OF NON-ADHERENCE IN CLINICAL TRIALS OF ANTIDEPRESSANTS FOR MAJOR DEPRESSION DISORDER: A SYSTEMATIC REVIEW AND METAANALYSIS.

Abstract

Major depression disorder is a serious mental issue which affects the physical and mental well-being of affected persons. Hence, there is a need to develop antidepressants to treat major depression disorder. However, medicine non-adherence is a major challenge in major depression disorder drug development. Similarly, medication adherence is an essential aspect of the success of antidepressant development. Adherence/non-adherence data informs the interpretation of antidepressant clinical results, reducing clinical risks and realising antidepressant benefits in clinical trials. However, adherence prevalence is a crucial aspect of clinical research, existing evidence points to underreporting adherence assessment methods and outcomes in published clinical trials. Also, RCTs that report adherence measures and outcomes fail to provide adequate methodology regarding adherence measures and outcomes. To improve the completeness and quality of the information in antidepressant clinical trials, this research examined medication adherence prevalence in RCTs, measures of adherence/non-adherence, and clinical and cost impacts of non-adherence. A systematic review and meta-analysis methodology was adopted. Meta-analysis findings affirm that medication adherence prevalence in clinical trials for antidepressant development is 72.2%, translating to a 27.8% non-adherence level. Qualitative findings from the studies established direct and indirect non-adherence measures of adherence, including self-report measures and the use of questionnaires. Impacts of non-adherence include disease relapse and recurrence (clinical impact) and increased clinical trial costs. Keywords: Major depression disorder, Antidepressant clinical trials, Non-adherence, Adherence, Adherence prevalence.