A clinical trial to study the effects of two drugs, fixed dose combination capsules of Paroxetine hydrochloride controlled release (CR) & Clonazepam and Paroxetine hydrochloride controlled release (CR) tablets in patients with co-morbid depression & anxiety
- Conditions
- Health Condition 1: null- Co-morbid depression and anxietyHealth Condition 2: F411- Generalized anxiety disorderHealth Condition 3: F339- Major depressive disorder, recurrent, unspecified
- Registration Number
- CTRI/2009/091/000162
- Lead Sponsor
- Cadila Healthcare Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1.Patients between 18-65 years of age
2.Patients with established diagnosis of co-morbid depression & anxiety (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition DSM-IV) with a total Hamilton Rating Scale for Depression (HAM-D) score more than and or equal to 14 and total Hamilton Rating Scale for Anxiety (HAM-A) score more than and or equal to 12
3.Informed consent of the patient or relative
1.Pregnancy and/or lactation
2.Patients with a history of mania, schizophrenia, seizures, narrow angle glaucoma, pre-existing CNS depression or coma, respiratory depression, acute pulmonary insufficiency, myasthenia gravis or sleep apnoea, chronic pulmonary insufficiency and/or muscle weakness
3.Patients with suicidal tendencies
4.Patients operating hazardous machinery, including automobiles
5.Patients with renal and/or hepatic insufficiency
6.Patients taking a mono amine oxidase inhibitor (MAOI), or within 14 days of discontinuing treatment with MAOI
7.Patients who have a history of hypersensitivity to Paroxetine and/or clonazepam and/or any components of the formulations
8.Patients with any other serious concurrent illness or malignancy
9.Patients with continuing history of alcohol and/or drug abuse
10.Participation in another clinical trial in the past 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 baselineTimepoint: 4-12 weeks
- Secondary Outcome Measures
Name Time Method (1)% of patients having a 50% reduction in the HAM-D and HAM-A total score at the end of the study as compared to baseline <br/ ><br>(2)% of patients having a total HAM-D and HAM-A score each of 7 at the end of the study. <br/ ><br>(3)% of patients having an assessment of 1 for ?very much improved? or 2 for ?much improved? in the global change score (CGI-I) assessment at each follow-up visit. <br/ ><br>(4)Degree of improvement in the mean CGI-S (global severity of the CGI scale) score as compared to baseline.Timepoint: 4-12 weeks