FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076476 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 25/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Heart Rate Variability and Stress Response among the Patients with Anxiety and Depression 
Scientific Title of Study   Correlation of Heart rate variability with severity of anxiety and depression in patients with Generalised anxiety disorder and Major depressive disorder using spandan 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sumit Mehta 
Designation  Associate Professor 
Affiliation  Shri Guru Ram Rai Institute of Medical and Health Sciences 
Address  Department of Psychiatry, Shri Mahant Indresh Hospital, Kargi - Patel Nagar Bypass, Industrial Area, Govt. Industrial Estate, Patel Nagar, Dehradun, Uttarakhand 248001

Dehradun
UTTARANCHAL
248001
India 
Phone  8979609595  
Fax    
Email  sumitmehta2010@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumit Mehta 
Designation  Associate Professor 
Affiliation  Shri Guru Ram Rai Institute of Medical and Health Sciences 
Address  Department of Psychiatry, Shri Mahant Indresh Hospital, Kargi - Patel Nagar Bypass, Industrial Area, Govt. Industrial Estate, Patel Nagar, Dehradun, Uttarakhand 248001


UTTARANCHAL
248001
India 
Phone  8979609595  
Fax    
Email  sumitmehta2010@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sumit Mehta 
Designation  Professor 
Affiliation  Shri Guru Ram Rai Institute of Medical and Health Sciences 
Address  Department of Psychiatry, Shri Mahant Indresh Hospital, Kargi - Patel Nagar Bypass, Industrial Area, Govt. Industrial Estate, Patel Nagar, Dehradun, Uttarakhand 248001


UTTARANCHAL
248001
India 
Phone  8979609595  
Fax    
Email  sumitmehta2010@gmail.com  
 
Source of Monetary or Material Support  
Sunfox Technologies Private Limited Address -112- Dharampur Road, Near Chilliz Restraurant, Nehru colony, Dehradun, Uttarakhand 
 
Primary Sponsor  
Name  Sunfox Technologies Private Limited  
Address  112, Dharampur Rd, Nehru Colony, Dharampur, Dehradun, Uttarakhand 248001 
Type of Sponsor  Other [Medical Device Manufacturer ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sumit Mehta  Shri Guru Ram Rai institute of Medical and Health Sciences  Demonstration Room of Psychiatry OPD, Shri Mahant Indresh Hospital, Patel Nagar, Dehradun, Uttarakhand
Dehradun
UTTARANCHAL 		 08979609595

sumitmehta2010@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Guru Ram Rai Institute of Medical and Health Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals without any history of psychiatric disorders, cardiac arrhythmias or underwent some primary coronary interventions Pregnant or breastfeeding women are also excluded.  
Patients  (1) ICD-10 Condition: F411||Generalized anxiety disorder, (2) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (3) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, (4) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, (5) ICD-10 Condition: F323||Major depressive disorder, singleepisode, severe with psychotic features, (6) ICD-10 Condition: F324||Major depressive disorder, singleepisode, in partial remission, (7) ICD-10 Condition: F324||Major depressive disorder, singleepisode, in partial remission, (8) ICD-10 Condition: F325||Major depressive disorder, singleepisode, in full remission, (9) ICD-10 Condition: F328||Other depressive episodes, (10) ICD-10 Condition: F329||Major depressive disorder, singleepisode, unspecified, (11) ICD-10 Condition: F330||Major depressive disorder, recurrent, mild, (12) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (13) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, (14) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, (15) ICD-10 Condition: F333||Major depressive disorder, recurrent, severe with psychotic symptoms, (16) ICD-10 Condition: F334||Major depressive disorder, recurrent, in remission, (17) ICD-10 Condition: F338||Other recurrent depressive disorders, (18) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Psychiatric patient groups that are Diagnosed with specific psychiatric conditions i.e. anxiety and depression under DSM-5 criteria by psychiatrist based on a detailed history. The Control group consists of healthy individuals without any history of psychiatric disorders.
 
 
ExclusionCriteria 
Details  1. Participants with significant cardiac arrhythmias or underwent some primary coronary interventions.
2. Pregnant or breastfeeding women.
3. Patients with other comorbid psychiatric conditions on the basis of detailed psychiatric interviews.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The study will access the correlation of the HRV parameters in time domain and frequency domain for the patients with the Anxiety and depression Disorders  10 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
The study may show distinctive HRV patterns between healthy human volunteers and patients with psychiatric conditions. These patterns may include variations in HRV parameters.   12 months 
The research may contribute to the identification of early signs or markers of anxiety and depression using HRV analysis. Detecting such signs in a home health care setting through HRV testing could be a crucial step toward early intervention and better mental health outcomes.
 		 12 months 
 
Target Sample Size   Total Sample Size="186"
Sample Size from India="186" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/11/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This is a prospective, observational, cross-sectional study aimed at collecting and analyzing data from 186 individuals, including patients with generalized anxiety, major depression, and a control group. All participants undergo HRV testing and complete the HAM-A, HAM-D, and Ardell Stress Scale assessments as part of their clinical care. The primary objective is to evaluate the significant correlation between HRV parameters in both psychiatric and non-psychiatric conditions. The secondary objective is to assess the effectiveness of HRV testing for early detection and monitoring of psychiatric conditions in home healthcare settings. 
Close