Actively Recruiting
Effect of Atenolol Versus Ivabradine on Heart Rate Variability in Treatment Resistant Schizophrenia Patients Taking Clozapine with Tachycardia: A Randomized Control Trial
Led by All India Institute of Medical Sciences, Bhubaneswar · Updated on 2024-07-17
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of Atenolol and Ivabradine on heart rate variability (HRV) in patients with Treatment Resistant Schizophrenia (TRS) who are taking clozapine and experiencing tachycardia. Clozapine is the only approved drug for TRS but can cause serious side effects including tachycardia, which may lead to stopping the medication. The study addresses the need to find effective treatments for clozapine-induced tachycardia by comparing these two drugs, as no direct comparison has been done before. Participants will be randomly assigned to receive either Atenolol 25mg once daily or Ivabradine 5mg twice daily for two months. Both drugs are being studied for their impact on heart rate and autonomic nervous system function in this patient group. The trial will measure changes in heart rate variability, blood pressure, pulse rate, and observe any adverse reactions during the treatment period. During the study, participants will undergo monitoring of heart rate variability using frequency and time domain measurements, blood pressure checks, and assessments of symptom severity using the PANSS scale. Safety and side effects will be tracked over the two months of treatment. The primary focus is to evaluate how each drug affects heart rate variability, an important marker of autonomic function, to help guide future management of tachycardia in TRS patients on clozapine.
CONDITIONS
Brief Title
Effect of Atenolol Versus Ivabradine on HRV in TRS Patients on Clozapine With Tachycardia: A Randomised Control Trial.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with Treatment Resistant Schizophrenia receiving clozapine
- Aged between 18 to 60 years
- Baseline heart rate greater than 100 beats per minute
- Written informed consent from a legally authorized representative
You will not qualify if you...
- Currently receiving Atenolol or Ivabradine
- Any contraindication to using Atenolol or Ivabradine
- Receiving any other medication besides Clozapine that causes autonomic dysregulation
- Active substance use
- Serious medical or neurological illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 months
Participants receive either Atenolol or Ivabradine to assess their effects on heart rate variability over 2 months.
Regular visits during the 2 months of treatment
Trial Site Locations
Total: 1 location
1
All India Institute of Medical Sciences
Bhubaneswar, Odisha, India, 751019
Actively Recruiting
Research Team
B
Biswa R Mishra, MD, DPM
A
Amit Bahmnia, MBBS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here