Comparing Atenolol and Ivabradine for Heart Rate Issues in Schizophrenia Patients on Clozapine
Effect Of Atenolol Versus Ivabradine On Heart Rate Variability In Treatment Resistant Schizophrenia Patients On Clozapine With Tachycardia: A Randomized Control Trial.
This study is testing whether Atenolol or Ivabradine can better help people with schizophrenia who are on clozapine and have a fast heart rate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences, Bhubaneswar Academic / other |
| Locations | 1 site (Bhubaneswar, Odisha) |
| Trial ID | NCT06505668 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Atenolol and Ivabradine on heart rate variability in patients with treatment-resistant schizophrenia who are experiencing tachycardia while on clozapine. The study aims to determine which medication is more effective in managing tachycardia without causing significant adverse effects. Patients aged 18 to 60 with a baseline heart rate over 100 beats per minute will be enrolled, and those with contraindications to either medication will be excluded. The trial will provide insights into safer management strategies for heart rate issues in this vulnerable patient population.
Who should consider this trial
Good fit: Ideal candidates are patients aged 18 to 60 diagnosed with treatment-resistant schizophrenia who are currently receiving clozapine and have a heart rate exceeding 100 beats per minute.
Not a fit: Patients already on Atenolol or Ivabradine, or those with contraindications to these medications, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a safer treatment option for managing tachycardia in patients with treatment-resistant schizophrenia on clozapine.
How similar studies have performed: While the use of beta-blockers for tachycardia is common, the specific comparison of Atenolol and Ivabradine in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: All patients coming for treatment at the Out-patient department and In-patient department of the Department of Psychiatry fulfilling the following are included: 1. Patients diagnosed with TRS (TRRIP consensus) receiving clozapine. 2. Aged between 18 to 60 years of either sex 3. Having baseline heart rate of \>100/minute. 4. Written informed consent from Legally Authorized representative. Exclusion Criteria: Patients with any one of the following are excluded from the study: 1. Already receiving Atenolol or Ivabradine. 2. Patients having any contraindication to using Atenolol or Ivabradine. 3. Receiving any other medication other than Clozapine known to cause autonomic dysregulation. 4. Active substance use. 5. Serious medical or neurological comorbidity.
Where this trial is running
Bhubaneswar, Odisha
- All India Institute of Medical Sciences — Bhubaneswar, Odisha, India (Recruiting)
Study contacts
- Principal investigator: Biswa Ranjan Mishra, MD — Professor and Head, Department of Psychiatry
- Study coordinator: Biswa R Mishra, MD, DPM
- Email: brm1678@gmail.com
- Phone: 9438884220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.