Indian Journal of Private Psychiatry

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VOLUME 19 , ISSUE 1 ( January-June, 2025 ) > List of Articles

RESEARCH ARTICLE

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

Anu Kant Mital, Manushree Gupta, Nilesh Shah, Sathianathan R, SVB Gupta, Manjula S, Krishna Kumar M

Keywords : Additive effects, Anxiety, Clonazepam, Fixed-dose combination, Propranolol

Citation Information : Mital AK, Gupta M, Shah N, R S, Gupta S, S M, M KK. 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. Ind J Priv Psychiatry 2025; 19 (1):11-16.

DOI: 10.5005/jp-journals-10067-0177

License: CC BY-NC 4.0

Published Online: 19-02-2025

Copyright Statement:  Copyright © 2025; The Author(s).


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.


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