| CTRI Number |
CTRI/2025/11/097615 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Extent and magnitude of Premenstrual Dysphoric Disorder and Premenstrual exacerbation of psychiatric disorders in females with mental illness. |
|
Scientific Title of Study
|
Evaluation of Premenstrual Dysphoric Disorder and Premenstrual exacerbation of psychiatric disorders |
| 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 Ganya Behl |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Psychiatry, Level 5, D- Block
Government Medical College and Hospital, Sector 32
Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
7009156589 |
| Fax |
|
| Email |
ganyabehl@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shivangi Mehta |
| Designation |
Assistant professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Psychiatry Level 5, D-block Government Medical College and Hospital Sector 32 Chandigarh
Chandigarh CHANDIGARH 160030 India |
| Phone |
9855784512 |
| Fax |
|
| Email |
shivangi02@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shivangi Mehta |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department of Psychiatry
Level 5 D Block,
Government Medical College and Hospital
Sector 32
Chandigarh
CHANDIGARH 160030 India |
| Phone |
9855784512 |
| Fax |
|
| Email |
shivangi02@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry, Level 5, D-Block, Government Medical College and Hospital, Sector 32, Chandigarh, 160030, India |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Department of Psychiatry, Level 5, D Block, Government Medical College and Hospital, Sector-32, Chandigarh, 160030 India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr GANYA BEHL |
Government Medical College and Hospital, Chandigarh |
Level 3, Psychiatry ward, Government
Medical College and
Hospital, South
Campus, Sector 48,
Chandigarh Chandigarh CHANDIGARH |
7009156589
ganyabehl@gmail.com |
| Dr GANYA BEHL |
Government Medical College and Hospital, Chandigarh |
Room No 4212, Level
4, B Block, Government
Medical College and
Hospital, Sector 32,
Chandigarh Chandigarh CHANDIGARH |
7009156589
ganyabehl@gmail.com |
| Dr GANYA BEHL |
Government Medical College and Hospital, Chandigarh |
Mental Health Institute, Sector 32, Chandigarh Chandigarh CHANDIGARH |
7009156589
ganyabehl@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(GMCH, Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, (2) ICD-10 Condition: F90-F98||Behavioral and emotional disorders with onset usually occurring in childhood and adolescence, (3) ICD-10 Condition: F50-F59||Behavioral syndromes associated with physiological disturbances and physical factors, (4) ICD-10 Condition: F60-F69||Disorders of adult personality and behavior, (5) ICD-10 Condition: F10-F19||Mental and behavioral disorders due to psychoactive substance use, (6) ICD-10 Condition: F30-F39||Mood [affective] disorders, (7) ICD-10 Condition: F80-F89||Pervasive and specific developmental disorders, (8) ICD-10 Condition: F20-F29||Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Females diagnosed with psychiatric disorder
Has had at least two menstrual cycles in the last 3 months |
|
| ExclusionCriteria |
| Details |
Females with evidence of organic brain syndrome or intellectual disability
Females diagnosed with neurodevelopmental disorders and neurodegenerative disorders
Pregnant or lactating females
Females taking oral contraceptive pills
violent/unco-operative females
Females with any acute, unstable, medical or surgical illnesses |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the extent of Premenstrual Dysphoric Disorder (PMDD) in females with mental illness. |
0,3-5 weeks, 7-9 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the magnitude of Premenstrual exacerbation of existing psychiatric disorders in females with mental illness.
|
0, 3-5 weeks, 7-9 weeks |
To assess the role and correlation of socio-demographic and clinical factors in PMDD and premenstrual exacerbation of existing psychiatric disorders.
|
0, 3-5 weeks, 7-9 weeks |
|
|
Target Sample Size
|
Total Sample Size="500" Sample Size from India="500"
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)
|
01/12/2025 |
| 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="1" 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 study aims to evaluate Premenstrual Dysphoric Disorder (PMDD) a severe disabling condition involving physical and psychological symptoms that occur a few days before menstruation and distinguish it from the cyclical worsening of existing psychiatric symptoms during the same time, known as premenstrual exacerbation. This study aims to evaluate Premenstrual Dysphoric Disorder (PMDD) a severe disabling condition involving physical and psychological symptoms that occur a few days before menstruation and distinguish it from the cyclical worsening of existing psychiatric symptoms. The aim is to evaluate Premenstrual Dysphoric Disorder (PMDD) and Premenstrual exacerbation of psychiatric disorders. The objectives are to estimate the extent of Premenstrual Dysphoric Disorder (PMDD) in females with mental illness, estimate the magnitude of premenstrual exacerbation of existing psychiatric disorders and role as well as correlation of socio-demographic and clinical factors in both PMDD and Premenstrual exacerbation. The study will be a prospective, observational study conducted over 18 months at GMCH, Chandigarh. A total of 500 females with mental illness will be screened using the Premenstrual Symptom Screening Tool (PSST). Those who screen positive will be followed across two visits at least 3-5 weeks apart over 12 weeks, depending on their menstrual cycle. Based on their existing diagnosis, participants will be grouped into categories including depressive disorder, anxiety disorder, bipolar disorder, schizophrenia spectrum, obsessive compulsive disorder, substance use disorders, and other disorders. Each follow-up will include assessments using DSM-5 criteria for PMDD, C-PASS, SOFAS, and disorder-specific clinician rated scales. The findings may enhance understanding, diagnosis, and management of PMDD and premenstrual symptom worsening in Indian women with mental illness, ultimately improving their quality of life. |