A Post marketing study to see safety and efficacy of combination of Amitriptyline and Chlordiazepoxide in management of depression with co-morbid anxiety
- Conditions
- Anxiety disorder, unspecified,
- Registration Number
- CTRI/2021/03/031971
- Lead Sponsor
- Dr Reddys Laboratories Ltd
- Brief Summary
This multicentric single arm post marketing surveillance study would be performed in patients of anxiety comorbid with depression, who have been newly prescribed FDC of Amitriptyline and Chlordiazepoxide tablets of Dr. Reddy’s Laboratories Ltd. All the enrolled patients will be followed up for 60 day and will be assessed for HAM-A and HAM-D assessment. Patients will be encouraged to report adverse events throughout the study period. All the data generated will be analysed using appropriate statistical test.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 375
Patient with anxiety comorbid with depression Newly Prescribed with Libotryp or Libotryp DS as per clinical discretion of investigator.
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 Libido Incidence of any of the following event | Sedative effects or Anticholinergic side effects | or Dizziness or Decrease in Libido or AE or SAE at Day 30 and Day 60 after study using study medication
- Secondary Outcome Measures
Name Time Method To passively evaluate Safety reports such as adverse drug reactions, laboratory parameters, ECG (if available) To evaluate Efficacy as change in Hamilton Anxiety Score (HAM-A) and Hamilton Depression Score (HAM-D) score
Trial Locations
- Locations (6)
Chopda Medicare and Research Centre Pvt limited Magnum Heart institute
🇮🇳Nashik, MAHARASHTRA, India
Dr D Y Patil Medical College hospital and research centre
🇮🇳Pune, MAHARASHTRA, India
K.S. Hegde Medical Academy
🇮🇳Kannada, KARNATAKA, India
Life Care Clinic
🇮🇳Salem, TAMIL NADU, India
Lokmanya Tilak Muncipal Medical college and general hospital
🇮🇳Mumbai, MAHARASHTRA, India
Sahyadri Super specialty hospital
🇮🇳Pune, MAHARASHTRA, India
Chopda Medicare and Research Centre Pvt limited Magnum Heart institute🇮🇳Nashik, MAHARASHTRA, IndiaUmesh NagapurkarPrincipal investigator9823146088umeshanjali@gmail.com