A Post marketing study to see safety and efficacy of combination of Amitriptyline and Chlordiazepoxide in management of depression with co-morbid anxiety
Phase 4
- Conditions
- Health Condition 1: F419- Anxiety disorder, unspecified
- Registration Number
- CTRI/2021/03/031971
- Lead Sponsor
- Dr Reddys Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patient with anxiety comorbid with depression
Newly Prescribed with Libotryp or Libotryp DS as per clinical discretion of investigator
Exclusion Criteria
Patients who is not able to understand the nature of study and willing to provide written informed consent.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To actively surveil safety of FDC of Amitriptyline and Chlordiazepoxide tablets in management of depression with co-morbid anxiety in India in terms of Sedative effects and Anticholinergic side effects and Dizziness and Decrease in LibidoTimepoint: Incidence of any of the following event <br/ ><br>Sedative effects or Anticholinergic side effects <br/ ><br> or Dizziness or Decrease in Libido or AE or SAE at Day 30 and Day 60 after study using study medication <br/ ><br>
- Secondary Outcome Measures
Name Time Method To passively evaluate Safety reports such as adverse drug reactions, laboratory parameters, ECG (if available) <br/ ><br>To evaluate Efficacy as change in Hamilton Anxiety Score (HAM-A) and Hamilton Depression Score (HAM-D) score <br/ ><br>Timepoint: Proportion of patients showing at least 50% decrease in baseline HAM-D and HAM-A scores at end of 30 days of therapy <br/ ><br>2.Proportion of patients showing at least 50% decrease in baseline HAM-D and HAM-A scores at end of 60 days of therapy <br/ ><br>