Efficacy, Safety and Tolerability of Clonazepam 0.25 mg and Propranolol 10/20 mg Fixed-dose Combination among Anxiety Disorder Patients: A Randomized, Double-blind, Multicentric, Active-controlled, Phase IV Study
Year: 2025
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Background and aim: Although monotherapy of anti-anxiety drugs is effective in controlling anxiety, due to the progressive nature of the disease, it is often associated with a lack of effectiveness over time.So, this study was carried out to assess the efficacy, safety, and tolerability of clonazepam 0.25 mg and propranolol 10/20 mg fixed-dose combination among anxiety disorder patients.Materials and methods: This was a randomized, double-blind, multicenter, actively-controlled, phase IV study conducted among individuals having established diagnosis of anxiety, total Hamilton Rating Scale for Anxiety (HAM-A) score ≥17, Clinical Global Impressions Severity (CGI-S) score >4 in the week prior to inclusion.The study participants were randomized to receive either the test or the reference drug once daily for 8 weeks.At the last study visit, the degree of a patient's anxiety was assessed by using the HAM-A and CGI-S scores.Results: At week 8, it was observed that there was a decrease in HAM-A score in all the groups.Between the group analysis, at visit 3, there was a reduction in the HAM-A score compared with the randomization visit.The investigator-rated scale and patient-rated global improvement were highest in group B followed by group C compared with group A. Also, there was a notable reduction in group A at week 8 in the CGI-S score as compared with baseline in group B. Conclusion: The combination of clonazepam and propranolol was effective, safe, and well-tolerated.Hence, it can be a significant armamentarium in anxiety disorder management.Clinical significance: The clonazepam 0.25 mg and propranolol 10/20 mg fixed-dose combination showed a significant decrease in the HAM-A score across patients with anxiety disorders and was found to be clinically effective, safe, and well-tolerated.
Authors: Rajesh Kumar, Nilesh Shah, Anu Kant Mital, Manushree Gupta, Sathianathan R, SVB Gupta, Manjula S, Krishna Kumar M
Institutions: Sri Ramachandra Institute of Higher Education and Research, Indira Gandhi Institute of Medical Sciences, Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Rajiv Gandhi Medical College, Safdarjang Hospital, Vardhman Mahavir Medical College & Safdarjung Hospital
Language: English
Subfield: Experimental and Cognitive Psychology
Field: Psychology
Domain: Social Sciences
Open Access status: diamond
OpenAlex ID: W4407815550