| CTRI Number |
CTRI/2025/07/091034 [Registered on: 16/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study to Find Out if Heartbeat Changes Can Help Choose the Right Treatment for Anxiety |
|
Scientific Title of Study
|
A study of Heart rate Variability for Prediction of Response to Selective Serotonin Reuptake Inhibitor (SSRI) & Selective partial Agonist and Reuptake Inhibitor (SPARI) in Generalised Anxiety Disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Daniyal Farooque |
| Designation |
Postgraduate Student |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh |
| Address |
Physiology department, JNMCH, AMU, ALIGARH, UTTAR PRADESH - 202002, INDIA
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9507446467 |
| Fax |
|
| Email |
daniyal.aadeez@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gul Ar Navi Khan |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Physiology Department, JNMCH, AMU, ALIGARH, UTTAR PRADESH 202002, INDIA
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8630948761 |
| Fax |
|
| Email |
dr.gular@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gul Ar Navi Khan |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Physiology Department,JNMCH, AMU, ALIGARH, UTTAR PRADESH 202002, INDIA
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8630948761 |
| Fax |
|
| Email |
dr.gular@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| JNMCH, AMU, ALIGARH, UTTAR PRADESH 202002, INDIA |
| NIL |
|
|
Primary Sponsor
|
| Name |
Daniyal Farooque |
| Address |
625/2 Haroon Nagar Sector 2, Phulwarisharif, Patna, BIHAR 801505, INDIA |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr DANIYAL FAROOQUE |
Hospital |
Physiology Department
Aligarh
UTTAR PRADESH |
9507446467
daniyal.aadeez@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F411||Generalized anxiety disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of generalized anxiety disorder with moderate or severe anxiety based on Hamilton anxiety rating scale (HAM-A) |
|
| ExclusionCriteria |
| Details |
Any physical or psychiatric co-morbidity except insomnia
Patient with heart disease or taking any heart rate controlling drugs like beta blockers.
Pregnancy
Patient with pacemaker implant.
Severe systemic disease, cardiopulmonary or kidney insufficiency
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart Rate Variability |
1. Baseline
2. After 8 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 study aimed at evaluating the role of heart rate variability in predicting response to Selective Serotonin Reuptake Inhibitors and Selective Partial Agonist and Reuptake Inhibitors in patients with Generalized Anxiety Disorder. Patients will be assigned to two treatment groups based on the prescribed medication and compared with a healthy control group. Heart rate variability and anxiety severity will be assessed before and after eight weeks of treatment. The study aims to identify whether heart rate variability can serve as a predictive marker to guide personalized treatment decisions in anxiety disorders |