Status:
RECRUITING
Effect of Atenolol Versus Ivabradine on HRV in TRS Patients on Clozapine With Tachycardia: A Randomised Control Trial.
Lead Sponsor:
All India Institute of Medical Sciences, Bhubaneswar
Conditions:
Treatment Resistant Schizophrenia
Clozapine Adverse Reaction
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Clozapine is the only drug approved for Treatment Resistant Schizophrenia. However, it has been associated with many adverse drug reactions including agranulocytosis, myocarditis, sialorrhea, constipa...
Detailed Description
Schizophrenia is a severe debilitating mental disorder characterised by distortions of thinking, perception and blunt affect. It poses a major healthcare burden with the prevalence of 1% worldwide. As...
Eligibility Criteria
Inclusion
- All patients coming for treatment at the Out-patient department and In-patient department of the Department of Psychiatry fulfilling the following are included:
- Patients diagnosed with TRS (TRRIP consensus) receiving clozapine.
- Aged between 18 to 60 years of either sex
- Having baseline heart rate of \>100/minute.
- Written informed consent from Legally Authorized representative.
Exclusion
- Patients with any one of the following are excluded from the study:
- Already receiving Atenolol or Ivabradine.
- Patients having any contraindication to using Atenolol or Ivabradine.
- Receiving any other medication other than Clozapine known to cause autonomic dysregulation.
- Active substance use.
- Serious medical or neurological comorbidity.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06505668
Start Date
August 1 2023
End Date
June 30 2025
Last Update
July 17 2024
Active Locations (1)
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1
All India Institute of Medical Sciences
Bhubaneswar, Odisha, India, 751019