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临床试验/CTRI/2026/01/100037
CTRI/2026/01/100037尚未招募不适用

Association of sodium channel Single Nucleotide Polymorphism (SNP) with valproate response among bipolar disorder patients in a tertiary care hospital A Longitudinal study.

Dr Aswiny P1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2026年1月18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
96
试验地点
1

研究概览

简要总结

This study is a longitudinal pharmacogenomic study aimed at evaluating the association between sodium channel gene single nucleotide polymorphisms (SNPs) and therapeutic response to valproate in patients with bipolar disorder from a South Indian population. Adult patients (18–60 years) diagnosed with bipolar disorder and prescribed sodium valproate will be enrolled and followed for 6 weeks. Treatment response will be assessed using Young Mania Rating Scale (YMRS) and Hamilton Depression Rating Scale (HDRS), and patients will be classified as responders or non-responders. Genotyping of SCN1A SNP (rs2298771) will be performed using PCR–RFLP technique. Secondary outcomes include medication adherence, safety profile, and proportion of non-responders. A total sample size of 96 participants will be included. Data will be analyzed using appropriate statistical tests to determine genetic association, with the aim of supporting personalized valproate therapy in bipolar disorder.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients who were prescribed with Sodium Valproate (VPA) for BPAD after initial stabilization with normal LFT.

排除标准

  • Hyperthyroidism,H/o Suicidal ideation Schizophrenic patients, Schizo-affective disorders or delusional disorders,Contraindications to VPA Mood disorder due to general medical condition (recent stroke, HIV infection, unstable medical condition) Substance abuse, Pregnant and Breastfeeding women.

研究者

发起方
Dr Aswiny P
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR ASWINYP

Indira Gandhi Medical College and Research Institute

研究点 (1)

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