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A clinical trial to study the effect of Escitalopram with and without Mindfulness-based therapy in patients who develop depression and anxiety after suffering from a heart attack

Efficacy of Escitalopram With and Without Mindfulness Based Therapy for managing post Myocardial Infarction Depression and Anxiety- a Randomized Control Trial - Nil

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063401
Enrollment
60
Registered
2024-03-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I219- Acute myocardial infarction, unspecified

Interventions

Intervention1: Tablet Escitalopram and Mindfulness-Based Therapy: Treatment Arm 2: Tablet Escitalopram 5–10 MG to be administered daily per orally + Mindfulness-Based Therapy to be followed daily for

Sponsors

Neha Mittal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Those with written informed consent. 2. Age group between 18 to 65 years of age. 3. All genders. 4.Ability to attend all required study visits. 5.Patients with recent diagnosis of Myocardial Infarction. 6.Admitted to Cardiology Unit of KIMS, Bhubaneswar. 7.Patients who are medically stable and planned for discharge

Exclusion criteria

Exclusion criteria: 1.Patients with diagnosis of Depression or Anxiety before the myocardial infarction 2.Patients with a major mental illness, like schizophrenia or bipolar disorder. 3.Patients currently on any psychotropic drugs. 4.Patients with Prominent Cognitive Impairment with a score less than 24 on screening Folstein Mental Status Exam. 5.Patients with a Comorbid Medical illness that is likely to interfere in assessment. 6.Persons with cancers and other debilitating diseases, or with life expectancy less than one year 7.Patients with Active Dependence (Except Tobacco). 8.Uncontrolled hypertension, or carotid artery stenosis; and acute medical or psychiatric symptoms likely to interfere with study participation.

Design outcomes

Primary

MeasureTime frame
1.Treatment response will be defined as 50 % reduction in HAM-D scores for patients with Depression 2.Treatment response will be defined as 50 % reduction in HAM-A scores for patients with Anxiety Timepoint: Time of discharge, 4 weeks after discharge and 8 weeks after discharge

Secondary

MeasureTime frame
Incidence of depressive or anxiety symptoms as measured by Hospital Anxiety and Depression Scale in 4 and 8 weeks follow upTimepoint: Time of discharge, 4 weeks after discharge and 8 weeks after discharge

Countries

India

Contacts

Public ContactNeha Mittal

Kalinga Institute of Medical Sciences

Pranab.mahapatra@kims.ac.in7752085533

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026