| 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
|
|
|
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
|
|
|
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. |