Adjunctive Pentoxifylline for cognitive deficits in Schizophrenia and its inflammatory correlates: an open label study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in levels of TNF- alpha, IL-6, BDNF as marker of improvement in inflammation on Tab. Pentoxifylline 800mg/d.
研究概览
简要总结
cognitive deficits are considered as the main core of schizophrenia, which are not caused by the side effects of antipsychotic drugs. the main affected cognitive aspects are attention, memory, reasoning, processing speed, and executive functions. studies show that biological events during the neurodevelopmental phase in adolescents leads to abnormal synaptic plasticity resulting in cognitive deficits. the key roles of TNF-Alpha, and IL-6 in regulating the excitability transmission of neuron cell and neurotransmitter metabolisms make them primary candidates for schizophrenia pathogenesis. patients with chronic schizophrenia exhibited elevated serum IL-6, TNF- Alpha, sIL-2R, IL-1beta and IL-18. Pentoxifylline is a methylxanthine derivative with anti-inflammatory and immune modulation effects; it increases the red blood cells membrane elasticity and decreases the blood viscosity and platelet aggregation so that it increases the blood flow.
therefore pentoxifylline 800mg BD will be given to patients for 8 weeks and blood markers will be checked at baseline. 4 weeks and 8 weeks alongwith scales for cognition.
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
- •Inpatients satisfying the ICD 10- DCR (1993) criteria for Schizophrenia with duration of illness of more than 2 years
- •Age 18 to 50 years.
- •Score on MoCA less than
- •CDSS score less than or equal to
- •Patients who give written informed consent for participating in the study.
排除标准
- •Any other major comorbid psychiatric diagnosis or significant concurrent medical illnesses.
- •Substance dependence in the last 6 months (excluding nicotine & caffeine).
- •Pregnant or lactating female patients.
- •Patients with organic brain disorder and/or mental retardation.
- •Patients on treatment with medications that can influence cognitive functioning: Anticholinergics (except trihexyphenidyl), 1st generation antipsychotics.
- •Patients on treatment with SSRI, SNRI, TCA or MAOI.
- •Patients who have received ECT in the past 6 months.
结局指标
主要结局
Change in levels of TNF- alpha, IL-6, BDNF as marker of improvement in inflammation on Tab. Pentoxifylline 800mg/d.
时间窗: 0 weeks, 4 weeks, 8 weeks
次要结局
- Improvement in cognititve deficits measured by CANTAB, MoCA with Tab. Pentoxifylline 800mg/d.(0 weeks, 4 weeks, 8 weeks)
研究者
Ishita Malik
Central institute of Psychiatry