Characterizing profile and clinical characteristics associated with mixed features in Bipolar Depression

Not yet recruiting

• Conditions: Bipolar disorder, current episodedepressed, mild or moderate severity,

• Registration Number: CTRI/2025/04/085585
• Lead Sponsor: All India Institute Of Medical Sciences, New Delhi

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-06
• Last Update Posted: 2025-04-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
•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).	cross-sectional assessment
•To evaluate the profile, clinical correlates, and factors associated with mixed features in DSM-5 bipolar depression	cross-sectional assessment
•To assess the level of agreement between BMD criteria, KMD criteria, and DSM-5 MFS	cross-sectional assessment

Trial Locations

Locations (1)

All India Institute Of Medical Sciences,New Delhi; 🇮🇳 South, DELHI, India

All India Institute Of Medical Sciences,New Delhi

🇮🇳South, DELHI, India

Dr Sakshi Sain

Principal investigator

8894518226

sakshisain98@gmail.com