Effect Of Atenolol Versus Ivabradine On Heart Rate Variability In Treatment Resistant Schizophrenia Patients On Clozapine With Tachycardia: A Randomized Control Trial.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
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⁃ 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.

Locations
Other Locations
India
All India Institute of Medical Sciences
RECRUITING
Bhubaneswar
Contact Information
Primary
Biswa R Mishra, MD, DPM
brm1678@gmail.com
9438884220
Backup
Amit Bahmnia, MBBS
amitbahmnia@gmail.com
9996445295
Time Frame
Start Date: 2023-08-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 40
Treatments
Active_comparator: Atenolol 25mg
Patients will be receiving Atenolol 25mg OD for 2 months.
Active_comparator: Ivabradine 10mg
Patients will be receiving Ivabradine 10mg (5mg BD) for 2 months.
Sponsors
Leads: All India Institute of Medical Sciences, Bhubaneswar

This content was sourced from clinicaltrials.gov