Assessment of serum uric acid and its association with short-term naturalistic course of manic episode in patients with bipolar I disorder
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
- 1) Assess and compare the serum uric acid across manic patients and matched
研究概览
简要总结
Worldwide, there is a high prevalence of
bipolar disorder(BD) and is a 6th leading
cause of disability in psychiatric patients. As
of now there is no identifiable biomarker
available for BD. Past studies have shown
some correlation with serum Uric Acid(UA)
however there is less evidence in the form of
prospective studies and only one study in the
Indian context and serum uric acid is an easily
measurable biomarker. As per predefined aims and objectives (stated above), and selection criteria (aforementioned), Out of the referred
patients, those with YMRSscore >12 will be chosen by a purposive method for
participation in the study. Healthy controls will be selected from attendants and non
biological relatives accompanying the patients. Diagnosis of BD-1 current episode mania will be confirmed using DSM-5 criteria by clinical interview and subjects fulfilling
the inclusion and exclusion criteria will be recruited. Subjects will be screened for
psychiatric comorbidities using clinical interviews. Physical, neurological and substance
use comorbidity as well as pregnancy/lactation will be ruled out by history and clinical
examination. Written consent will be taken prior to participation in the study.
Baseline assessments would be done. Sociodemographic and Clinical data
(Semi-structured datasheet) would be recorded. Questionnaires (PHQ-9 and GAD-7
screening) would be applied and 5 ml blood would be drawn (for Serum uric acid,
KFT,LFT,TSH,FBS,Total cholestrol estimation) would be done for the control group.
For the case group, sociodemographic, clinical data(semi structured datasheet) along
with the assessment scales including YMRS, CGI-BP, BVC-6 item, GAF,IPQ-SF would be
applied. 5 ml blood would be drawn (for Serum uric acid, KFT,LFT,TSH,FBS,Total
cholestrol estimation).
The cases will be followed up for 10 weeks that include 3 time points that is 2 weeks±
4 days, 4 weeks ±1 week and 10 week ±2 weeks .at every follow up clinical proforma,
assessment scales( YMRS,CGI-BP,GAF IPAQ-SF) would be applied along with 2 ml
fasting blood sample for serum uric estimation. Completers would be the patients who
followed up at once after the baseline assessment.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria for cases 18 to 45 years and Meeting DSM 5 criteria for Bipolar 1 disorder current episode mania.
- •Inclusion criteria for Controls comprise 18 to 45 years, and screen negative using PHQ-9 and GAD-.
排除标准
- •Exclusion criteria for Cases:
- •Any co occurring psychiatric illness or intellectual disability( as per known history)
- •Any current use of substance apart from nicotine ( as per known history)
- •Any known medical condition that has the potential to interfere with the the study assessments
- •Pregnancy or lactation
- •ECT in past 1 month Exclusion criteria for Controls:
- •GAD score>10 or PHQ-9 score>10
- •Any psychiatric illness or intellectual disability( as per known history)
- •Pregnancy or lactation.
结局指标
主要结局
1) Assess and compare the serum uric acid across manic patients and matched
时间窗: Baseline, followed by 3 time points in next 10 weeks , that is week 2,4, and 10. Completers will be any 2 time points including baseline
healthy controls 2)Assess the clinical profile, including symptom severity and its association with
时间窗: Baseline, followed by 3 time points in next 10 weeks , that is week 2,4, and 10. Completers will be any 2 time points including baseline
serum uric acid in patients with mania at baseline and prospective follow-up
时间窗: Baseline, followed by 3 time points in next 10 weeks , that is week 2,4, and 10. Completers will be any 2 time points including baseline
次要结局
- Assess the clinical profile, including symptom severity and its association with(serum uric acid in patients with mania at baseline and prospective follow-up)
研究者
Priyanka
AIIMS, New Delhi