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CTRI Number  CTRI/2024/10/075896 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 22/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Psychiatric co-morbidities in patients with headache 
Scientific Title of Study   A cross sectional study assessing psychiatric co-morbidities in patients with headache 
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 Nishant Yadav 
Designation  Post Graduate Resident 
Affiliation  Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, U.P 
Address  Department of Psychiatry, Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, U.P

Shahjahanpur
UTTAR PRADESH
242307
India 
Phone  9990197579  
Fax    
Email  nishantraoy@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Alexander Martin Alphonse 
Designation  Professor and Head of Department of Psychiatry 
Affiliation  Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, U.P 
Address  Department of Psychiatry, Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, U.P

Shahjahanpur
UTTAR PRADESH
242307
India 
Phone  9820123848  
Fax    
Email  talentsondisplay@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Alexander Martin Alphonse 
Designation  Professor and Head of Department of Psychiatry 
Affiliation  Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, U.P 
Address  Department of Psychiatry, Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, U.P


UTTAR PRADESH
242307
India 
Phone  9820123848  
Fax    
Email  talentsondisplay@gmail.com  
 
Source of Monetary or Material Support  
Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, 242307, Uttar Pradesh, India 
 
Primary Sponsor  
Name  Dr Nishant Yadav 
Address  Department of psychiatry, Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, 242307, Uttar Pradesh, India 
Type of Sponsor  Other [Self] 
 
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 Nishant Yadav  Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, 242307, Uttar Pradesh  Department of Psychiatry Room No.-235
Shahjahanpur
UTTAR PRADESH 
9990197579

nishantraoy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Varun Arjun Medical College and Rohilkhand Hospital, NH24, Banthra, Shahjahanpur, Uttar Pradesh-242307  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R50-R69||General symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with primary headache disorders.
2. Patients willing to participate in the study. 
 
ExclusionCriteria 
Details  1. Individuals with a prior history of substance abuse or addiction.
2. Patients currently receiving treatment for psychiatric conditions that may impact the study outcome.
3. Patient who are pregnant or breastfeeding. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
nil  nil 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/12/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

Headache represents the most common and incapacitating public health issue, with a lifetime prevalence of 64%. Headache are classified into two key categories: primary and secondary headaches. “Primary headaches” constitute ninety percent of all headaches, with “migraine and tension headaches” being the most prevalent types. Migraine and tension-type headaches are widely recognized responses to both psychological and physiological stressors. Individuals experiencing migraine alongside psychiatric comorbidities exhibit developed headache occurrence and greater impact than those without such comorbidities. Numerous studies have characterized headaches as the primary somatic manifestation of depression in both primary care and general healthcare settings, often accompanied by symptoms such as fatigue, muscle aches, dizziness, palpitations, and disturbances in sleep patterns. Shared biological pathways and the involvement of neurotransmitters like norepinephrine and serotonin provide a plausible explanation for the coexistence and interactions between pain disorders and depressive and anxiety disorders. There is a paucity of information concerning the study of psychiatric comorbidities in subjects with headache. Therefore, the present study is undertaken to evaluate the prevalence and severity of psychiatric comorbidities among patients diagnosed with various types of headaches.

 
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