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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  
NIL 
 
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  
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 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  
Status 
Not Applicable 
 
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.

 
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