NCT06505668 Effect of Atenolol Versus Ivabradine on HRV in TRS Patients on Clozapine With Tachycardia: A Randomised Control Trial.
| NCT ID | NCT06505668 |
| Status | Recruiting |
| Phase | — |
| Sponsor | All India Institute of Medical Sciences, Bhubaneswar |
| Condition | Treatment Resistant Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-08-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-08-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, constipation, orthostasis, tachycardia. There are many factors that have impacted the use of clozapine in TRS patients including physician hesitation, patient denial, stopping of drug due to Adverse drug reactions. Although Tachycardia should not be the reason to stop clozapine, but data shows that it leads to discontinuation of drugs in significant patient population. If patient on clozapine develops tachycardia; first orthostasis, myocarditis and systemic infection should be ruled out. Tachycardia traditionally have been treated with B1 adrenergic blockers such as Atenolol. But the problem with beta blocker medications is that significant proportion develops hypotension. Recently developed Ivabradine slows heart rate via I(f) current, and is not associated with much cardiac adverse effects. Recent Clinical trials have been carried out to show its effects on Clozapine associated tachycardia which shows promising results. Some studies suggest using Ivabradine in patient population that have contraindication for beta blockers. Although both of these drugs are used widely in clinical practice, but as Ivabradine is relatively new drug there have been no head-to-head comparison with Atenolol. A recent meta-analysis tried to compare treatment efficacy in these patients, but found no studies that met their inclusion criteria. This current study attempts to make such comparison and guide further research.
Eligibility 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.
Contact & Investigator
Biswa Ranjan Mishra, MD
PRINCIPAL INVESTIGATOR
Professor and Head, Department of Psychiatry
Frequently Asked Questions
Who can join the NCT06505668 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Treatment Resistant Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06505668 currently recruiting?
Yes, NCT06505668 is actively recruiting participants. Contact the research team at brm1678@gmail.com for enrollment information.
Where is the NCT06505668 trial being conducted?
This trial is being conducted at Bhubaneswar, India.
Who is sponsoring the NCT06505668 clinical trial?
NCT06505668 is sponsored by All India Institute of Medical Sciences, Bhubaneswar. The principal investigator is Biswa Ranjan Mishra, MD at Professor and Head, Department of Psychiatry. The trial plans to enroll 40 participants.
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