| CTRI Number | CTRI/2025/04/085585 [Registered on: 24/04/2025] Trial Registered Prospectively | 
    | Last Modified On: | 21/04/2025 | 
	
    | Post Graduate Thesis | Yes | 
    | Type of Trial | Observational | 
    | Type of Study | Cross Sectional Study | 
    | Study Design | Single Arm Study | 
    | Public Title of Study | Characterizing profile and clinical characteristics associated with mixed features in Bipolar Depression | 
    | Scientific Title of Study | Characterizing profile and clinical characteristics associated with mixed features in DSM-5 Bipolar Depression : An Observational, cross-sectional study | 
    | Trial Acronym | Nil | 
    | Secondary IDs if Any | 
    
        | Secondary ID | Identifier |  
            | NIL | NIL |  | 
    | Details of Principal Investigator or overall Trial Coordinator (multi-center study) | 
        
            | Name | Sakshi Sain |  
            | Designation | Junior Resident |  
            | Affiliation | All India Institute Of Medical Sciences , New Delhi |  
            | Address | Room no.-4096, Department of Psychiatry, 4th floor , Teaching Block All India Institute Of Medical Sciences, New Delhi 
 New Delhi
 DELHI
 110049
 India
 |  
            | Phone | 8894518226 |  
            | Fax |  |  
            | Email | sakshisain98@gmail.com |  | 
    | Details of Contact Person Scientific Query
 | 
        
            | Name | Prof Raman Deep |  
            | Designation | Professor |  
            | Affiliation | AIIMS, New Delhi |  
            | Address | Department of Psychiatry, 
All India Institute Of Medical Sciences, New Delhi 
 South
 DELHI
 110029
 India
 |  
            | Phone | 01126593236 |  
            | Fax |  |  
            | Email | drramandeep@gmail.com |  | 
    | Details of Contact Person Public Query
 | 
        
            | Name | Prof Raman Deep |  
            | Designation | Professor |  
            | Affiliation | AIIMS, New Delhi |  
            | Address | Department of Psychiatry, 
All India Institute Of Medical Sciences, New Delhi 
 South
 DELHI
 110029
 India
 |  
            | Phone | 26593236 |  
            | Fax |  |  
            | Email | drramandeep@gmail.com |  | 
    | Source of Monetary or Material Support |  | 
    | Primary Sponsor | 
        
            | Name | All India Institute Of Medical Sciences, New Delhi |  
            | Address | All India Institute Of Medical Sciences, New Delhi, Ansari Nagar, New Delhi, 110029 |  
            | Type of Sponsor | Government medical college |  | 
    | 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 Sakshi Sain | All India Institute Of Medical Sciences,New Delhi | Room No:-4096, Department Of Psychiatry, 4th floor, Teaching block, All India Institute Of Medical Sciences, Ansari Nagar, New Delhi-110029 South
 DELHI
 | 8894518226 
 sakshisain98@gmail.com
 |  | 
    | Details of Ethics Committee | 
    
           | No of Ethics Committees= 1 |  
                | Name of Committee | Approval Status |  
                | AIIMS INSTITUTIONAL ETHICS COMMITTEE | Approved |  | 
    | Regulatory Clearance Status from DCGI |  | 
    | Health Condition / Problems Studied | 
            
                | Health Type | Condition |  
    		| Patients | (1) ICD-10 Condition: F313||Bipolar disorder, current episodedepressed, mild or moderate severity, |  | 
    | Intervention / Comparator Agent | 
            
                | Type | Name | Details |  
    | Intervention | Nil | Nil |  | 
    | Inclusion Criteria | 
            
                | Age From | 18.00 Year(s) |  
                | Age To | 70.00 Year(s) |  
                | Gender | Both |  
                | Details | Aged 18 years and above Fulfilling the DSM-5 criteria for BD (I, II, Other Specified)
 Fulfilling minimum required criteria (5 or more that 5 out of 9 with at least one of the two (which is , low mood/ anhedonia) for major depressive episode (MDE)
 Current score on 17-item HAM-D is 8 or more than 8.
 Availability of informed consent
 |  | 
    | ExclusionCriteria | 
	            
            
                               
            
                | Details | Current psychiatric comorbidity (as per clinical history and records Current substance dependence (ASSIST equal or more than 27) except for nicotine
 Intellectual disability or organic brain syndrome (as per clinical history and records)
 Uncooperative patients or those unwilling to participate
 Major medical or neurological illness which may interfere with assessments
 |  | 
    | Method of Generating Random Sequence | Not Applicable | 
    | Method of Concealment | Not Applicable | 
    | Blinding/Masking | Not Applicable | 
    | Primary Outcome | 
             
                | Outcome | TimePoints |  
                | •	To assess and describe the clinical characteristics of mixed features in bipolar depression, and examine their relationship with Benazzi’s mixed depression (BMD) criteria, Koukopoulos’ criteria (KMD) and DSM-5 mixed features specifier (MFS). •	To evaluate the profile, clinical correlates, and factors associated with mixed features in DSM-5 bipolar depression
 •	To assess the level of agreement between BMD criteria, KMD criteria, and DSM-5 MFS
 
 | cross-sectional assessment |  | 
    | Secondary Outcome | 
             
                | Outcome | TimePoints |  
                | nil | NA |  | 
    | Target Sample Size | Total Sample Size="100" Sample Size from India="100"
 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) | 01/06/2025 | 
	
| 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 observational, cross-sectional study aims to assess and characterize the clinical features associated with mixed features in bipolar depression, using DSM-5 criteria, Benazzi’s mixed depression (BMD), and Koukopoulos’ criteria (KMD). A minimum of 100 adult participants, diagnosed with bipolar depression (BD I, II, or other specified types), and meeting DSM-5 criteria for a current major depressive episode, will be recruited from outpatient and inpatient services of the Psychiatry Department at AIIMS, New Delhi. Convenience sampling will be used. Patients with psychiatric or neurological comorbidities, substance dependence (except nicotine), or uncooperative behavior will be excluded.Data will be collected through semi-structured interviews and standardized assessment tools, including BDRS, KMDRS, YMRS, HAM-A, CUDOS-M, CGI-BP, NIMH Life Chart, IGLSI, CSSRS, and SPAQ. The study will explore symptom profiles, associated clinical correlates, and the degree of overlap among diagnostic criteria using descriptive statistics, discriminant analysis, regression models, and Fleiss’ kappa for inter-criteria agreement. Ethical clearance will be obtained, and written informed consent will be required. The study aims to contribute to a better understanding of mixed features in bipolar depression within an Indian context, offering potential insights into diagnostic validity and improving clinical recognition of mixed states for appropriate intervention. |