Safety and effectiveness of fixed dose combination of amitriptyline and chlordiazepoxide (Libotryp® and Libotryp-DS®) in the management of depression with co-morbid anxiety: protocol and design of a prospective, single arm, multi-centric, PMS study

Abstract

Background: Depression and anxiety are most disabling psychiatric conditions and add significantly to global health-related burden. Lifetime prevalence of major depression and anxiety disorders are very common and many times they can co-exist in the same time frame. The outcomes are poorer in such situations and compliance to medication is key to improve prognosis. A combination of tricyclic antidepressants and benzodiazepine is more practical in terms of compliance, and advantageous than that of a single class of drugs for the management of depression with co-morbid anxiety. This study will evaluate the safety and effectiveness of a fixed dose combination of amitriptyline and chlordiazepoxide as a part of post marketing surveillance. Methods: This is a prospective, single-arm, multi-centre, study which enrols patients who have been initiated with FDC of amitriptyline and chlordiazepoxide (Libotryp^®: amitriptyline 12.5 mg and chlordiazepoxide 5 mg or libotryp-DS^®: amitriptyline 25 mg and chlordiazepoxide 10 mg) tablets for the treatment of depression with co-morbid anxiety. A total of 375 patients will be enrolled and clinical assessments for safety will be done at follow up visits; assessments for effectiveness will be done using Hamilton Depression Rating Scale (HDRS or HAM-D) and Hamilton Anxiety Rating Scale (HARS or HAM-A). Conclusions: This study will provide more evidence on safety and usefulness of FDC of amitriptyline and chlordiazepoxide for the treatment of depression with co-morbid anxiety from Indian context. Trial registration: Trial registration number is CTRI/2021/03/031971.