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临床试验/CTRI/2025/04/085585
CTRI/2025/04/085585尚未招募不适用

Characterizing profile and clinical characteristics associated with mixed features in DSM-5 Bipolar Depression : An Observational, cross-sectional study

All India Institute Of Medical Sciences, New Delhi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
•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).

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 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
  • Availability of informed consent.

排除标准

  • 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.

结局指标

主要结局

•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).

时间窗: cross-sectional assessment

•To evaluate the profile, clinical correlates, and factors associated with mixed features in DSM-5 bipolar depression

时间窗: cross-sectional assessment

•To assess the level of agreement between BMD criteria, KMD criteria, and DSM-5 MFS

时间窗: cross-sectional assessment

次要结局

未报告次要终点

研究者

发起方
All India Institute Of Medical Sciences, New Delhi
申办方类型
Government medical college

研究点 (1)

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