High Dose Betahistine In Schizophrenia Metabolic Effects And Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Tab. Betahistine (72mg per day in 3 divided doses) will help in improving the metabolic and cognitive effects in the patient of schizophrenia with Olanzapine
研究概览
简要总结
Schizophrenia is a severe psychiatric disorder marked by positive, negative, and cognitive symptoms that significantly impair functioning. Second-generation antipsychotics (SGAs), particularly Olanzapine, are widely used for treatment but are associated with adverse metabolic effects such as weight gain, dyslipidemia, and increased risk of metabolic syndrome. These metabolic disturbances may further contribute to cognitive decline in patients with schizophrenia.
Betahistine, a histamine H1 receptor agonist and H3 receptor antagonist, has shown promise in mitigating SGA-induced metabolic side effects and improving cognitive functions. This open-label clinical trial, conducted at the Central Institute of Psychiatry, Ranchi, aims to evaluate the metabolic and cognitive effects of high-dose Betahistine (72 mg/day) when used as an adjunct to Olanzapine in patients with schizophrenia.
A total of 40 drug-naïve patients, aged 18–50 years and diagnosed with first-episode schizophrenia, will be randomly allocated into two groups. Group 1 will receive Betahistine plus Olanzapine, and Group 2 will receive Olanzapine alone. Assessments will be carried out at baseline, 4 weeks, and 8 weeks, including metabolic profile, cognitive tests (MoCA, CANTAB), serum Neuropeptide Y levels, and symptom severity (PANSS, CGI).
The study aims to explore whether Betahistine can reduce Olanzapine-induced metabolic side effects and enhance cognitive performance in schizophrenia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Inpatients satisfying the ICD 10 DCR (1993) criteria for Schizophrenia 2 First episode schizophrenia (Duration less than or equal to 2 Years) 3 Age 18 to 50 years of either gender 4 Patients with Healthy BMI (18.5 to 24.9) and not fulfilling the criteria for Metabolic Syndrome 5 Patient currently on Tab.
- •Olanzapine as Second Generation Antipsychotics 6 Score on MoCA less than 26 7 Moderately severe or less ( Less than or equal to 5) severity rating on PANSS items 8 Patients who give written informed consent for participating in the study.
排除标准
- •1 Any other major comorbid psychiatric diagnosis or significant concurrent medical illnesses 2 Pregnant or lactating female patients 3 Patients with organic brain disorder and or mental retardation 4 Patients on treatment with medications that can influence cognitive functioning like Anticholinergics (except trihexyphenidyl) 1st generation antipsychotics 5 Patients on treatment with medications that can influence metabolic profile 6 Patients on treatment with SSRI SNRI TCA or MAOI 7 Patients who have received ECT in the past 6 months.
结局指标
主要结局
Tab. Betahistine (72mg per day in 3 divided doses) will help in improving the metabolic and cognitive effects in the patient of schizophrenia with Olanzapine
时间窗: Tab. Betahistine (72mg per day in 3 divided doses) will help in improving the metabolic and cognitive effects in the patient of schizophrenia with Olanzapine
次要结局
未报告次要终点
研究者
Yash Modi
Central Institute Of Psychiatry