Pentoxifylline Add-on Therapy for Schizophrenia: A Randomized, Placebo-controlled, Double-blind Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Positive and negative symptoms
研究概览
简要总结
The etiology and pathogenesis of schizophrenia remain unclear. The immune dysfunction hypothesis for schizophrenia has attracted increasing attention from researchers, and substantial evidence suggested that the levels of TNF-α and other cytokines are markedly elevated in patients with schizophrenia. The investigators aim to evaluate the adjuvant therapeutic effect of Pentoxifylline, a TNF-α inhibitor that crosses the blood-brain barrier, in a randomized, double-blind, 6-week trial. Individuals with schizophrenia will receive either Pentoxifylline or a matching placebo as an add-on treatment to antipsychotic agents. Subjects' positive and negative symptoms and plasma concentration of neuroinflammatory markers will be monitored at baseline and every two weeks until the end of the trial.
详细描述
Ninety schizophrenic patients will be randomized to a Pentoxifylline (400 mg twice a day) or placebo treatment for six weeks. Pentoxifylline and placebo will be added to the current antipsychotic drug treatment. Participants will be asked to fill a socio-demographic questionnaire and to undergo a clinical differential diagnosis using the Symptoms Check List (SCL)-90, Clinical Global Impression (CGI), positive and negative symptoms scale (PANSS), and Hamilton depression rating scale (HAM-D). Following baseline evaluation, participants will be monitored for symptoms every two weeks until the end of the trial (overall three visits) using CGI, PANSS, and HAM-D. Adverse effects will be documented every visit using the Treatment Emergent Symptom Scale. Finally, yet importantly, a blood sample will be collected at baseline and every two weeks until the end of the trial to study the treatment effect on inflammatory markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients meeting the DSM-V criteria for schizophrenia spectrum disorders.
- •Clinical Global Impression (CGI) score ≥ 4 and ≤ 6 at screening.
- •Initiated treatment with a stable dosage of typical and/or atypical antipsychotic medication for at least four weeks.
排除标准
- •Previous sensitivity to pentoxifylline (PTF).
- •Chronic immune and/or inflammatory diseases (such as rheumatoid arthritis, systemic lupus erythematosus, chronic inflammatory bowel disease).
- •Consumption for > 3 consecutive days of any immune-modulating or anti-inflammatory drug in the last month.
- •Current active and persistent substance and/or alcohol abuse.
- •Any severe, unstable medical condition (e.g., cardiovascular disorders, diabetes mellitus, respiratory diseases, cancer).
- •Obesity (body mass index > 30).
- •Cognitive dysfunction such as retardation.
- •Known or suspected pregnancy or breastfeeding women.
- •Lactose intolerance or sensitivity.
研究组 & 干预措施
Pentoxifylline
Pentoxifylline (Oxopurin 400 mg)
干预措施: Oxopurin (Drug)
Placebo
Placebo (105 mg Lactose and 510 mg Dextrose)
干预措施: Oxopurin (Drug)
结局指标
主要结局
Positive and negative symptoms
时间窗: Subjects will be monitored at baseline and every two weeks for six weeks
Improvement in positive and negative symptoms (Changes in PANSS rates)
次要结局
- Depressive symptoms(Subjects will be monitored at baseline and every two weeks for six weeks)