A Study to Evaluate the Safety, Efficacy and Tolerability of Clonazepam 0.25 mg and Clonazepam 0.25mg with Propranolol 10/20 mg in Patients With Anxiety disorders
- Conditions
- Anxiety Disorders
- Registration Number
- CTRI/2017/12/010962
- Lead Sponsor
- Micro Labs Limited
- Brief Summary
This is A randomized, double-blind, multicentric, active controlled Phase IV clinical study to evaluate the Safety, Efficacy and Tolerability of fixed dose combination of Clonazepam 0.25 mg and Propranolol 10/20 mg in patients with anxiety disorders.
The total sample size of trial is 150. The total duration of study is 8 week.
The clinical efficacy will be tested by the following parameter (Primary Outcome)
ï‚· Change in the score on the Hamilton Rating Scale for Anxiety (HAM-A) at the end of treatment(8th week) as compared to baseline
The clinical safety and efficacy will be tested by the following parameter
ï‚· Percentage of patients having a 50% reduction in the HAM-A total score at the end of the study (8th week) as compared to baseline
ï‚· Degree of improvement in the mean CGI-S (global severity of the CGI scale) score at the end of study (8th week) as compared to baseline.
ï‚· Safety and tolerability of the study drug will be assessed by monitoring vital signs, physical examination, ECG, clinically significant changes in laboratory parameters and adverse events
The safety of the drug(s) during the study will be monitored by adverse effect monitoring during patient visits or through telephonic information in between visits, & laboratory investigations.
The compliance will also be monitored by pill-counting the left over medication during patient visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 150
- Patients between 18- 65 years of age 2.
- Patients with established diagnosis of Anxiety (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM V) 3.
- Total Hamilton Rating Scale for Anxiety (HAM-A) score ≥17 4.
- CGI-S score greater than 4 in the week prior to inclusion of the study.
- Willingness and able to give informed consent and comply with requirements for participation in the study.
- 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, hyper thyroidism, myasthenia gravis, diabetes mellitus, 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 who have a history of hypersensitivity to clonazepam and/or Propranolol and/or any components of the formulations 7.
- Patients with any other serious concurrent illness or malignancy 8.
- 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 Anxiety (HAM-A) at the end of treatment(8th week) as compared to baseline Baseline to week 8
- Secondary Outcome Measures
Name Time Method Degree of improvement in the mean CGI-S (global severity of the CGI scale) score at the end of study (8th week) as compared to baseline. Baseline to week 8 Percentage of patients having a 50% reduction in the HAM-A total score at the end of the study (8th week) as compared to baseline
Trial Locations
- Locations (8)
Chhatrapati Shivaji Maharaj Hospital
🇮🇳Thane, MAHARASHTRA, India
Indira Gandhi Institute of Medical Sciences
🇮🇳Patna, BIHAR, India
LTMMC & LTMGH Sion Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Manobal Klinik
🇮🇳Delhi, DELHI, India
Rajiv Gandhi Institute of Medical Sciences and Government General Hospital, Srikakulam
🇮🇳Srikakulam, ANDHRA PRADESH, India
Spandana Nursing Home
🇮🇳Rural, KARNATAKA, India
Sri Ramachandra Medical College and Research Institute
🇮🇳Chennai, TAMIL NADU, India
VNMC & Safdarjung Hospital
🇮🇳Delhi, DELHI, India
Chhatrapati Shivaji Maharaj Hospital🇮🇳Thane, MAHARASHTRA, IndiaDr Anu Kant MitalPrincipal investigator9820164327akmital@gmail.com