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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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