A Comparative Study to Assess the Efficacy and Safety of Combination Capsules of Paroxetine and Clonazepam in comparison to Paroxetine in patients suffering from Co-morbid Depression and Anxiety.

ABSTRACT

Depression and anxiety disorders are distinct illnesses that often coexist. Patients suffering from both disorders have more psychological, physical, and social impairment than do patients suffering from either illness alone. An open label comparative multicentric study was conducted to assess the efficacy and safety of therapy with fixed dose combination capsules of Paroxetine (25 mg) controlled release (CR) and Clonazepam (0.5 mg) in comparison to Paroxetine (25 mg) controlled release (CR) tablets in Indian patients suffering from co-morbid depression and anxiety. Patients between 18-65 years of age and established diagnosis of co-morbid depression and anxiety (as per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]) with a total Hamilton Rating Scale for Depression (HAM-D) score 14 and total Hamilton Rating Scale for Anxiety (HAM-A) score 12 were screened for enrolment in the study after taking their informed consent. The primary efficacy variables were the change in the score on the Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) at the end of treatment as compared to baseline. There was a significant decline in the mean HAM-D score from 21.4 ± 2.5 (range 17-27) at baseline to 11.7 ± 1.8 (range 8-15) at the end of the treatment in Group A and from 20.4 ± 2.1 (range 16-23) at baseline to 12.0 ± 1.1 (range 10-14) at the end of the treatment in Group B. In conclusion, we found that the fixed dose combination capsules of Paroxetine (25 mg) controlled release (CR) and Clonazepam (0.5 mg) are more effective and equally well tolerated as Paroxetine (25 mg) controlled release (CR) tablets in the management of patients with co-morbid depression and anxiety at our centre.