Effect of Anti-inflammatory Treatments on the Symptoms, Cognition, and Functioning of Adolescents With Schizophrenia
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Cognition: MATRICS Consensus Cognitive Battery (MCCB) scores
研究概览
简要总结
A double-blind controlled trial assessing the efficacy of anti-inflammatories on symptoms and cognition of adolescents with schizophrenia
详细描述
Patients will be evaluated to confirm the diagnosis of schizophrenia, duration of the disease and record a history of atopic diseases or recurrent infections throughout life. The PANSS, PSP, and MCCB battery scales will be administered. A blood sample will be taken for the determination of markers of inflammation before the start of pharmacological treatment.
Patients will start the antipsychotic medication assigned by their treating physician. They will also be assigned randomly to the treatment arm. The study drug will be provided by the research team under the presentation of capsules containing Celecoxib 200 mg, Minocycline 100 mg or Placebo, and patients will be instructed to take one capsule every 12 hrs daily.
The patient will be reassessed with PANSS, PSP, and MCCB after completing 6 weeks of pharmacological treatment, type and dose of medication will be recorded and serum markers of inflammation will be determined again.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia or schizophreniform disorder.
- •Patients in their first psychotic episode or previously diagnosed
- •No specific pharmacological treatment (antipsychotic at therapeutic doses in regular doses) in the previous two weeks.
- •Have a responsible parent or guardian.
排除标准
- •Active infection
- •Chronic somatic diseases, including autoimmune diseases
- •Comorbidity with anorexia, substance use disorders
- •Pregnancy
- •Use of anti-inflammatory medications or antibiotics
研究组 & 干预措施
Placebo
Placebo capsules twice a day
干预措施: Placebo oral capsule (Drug)
Celecoxib
Celecoxib 200 mg twice a day
干预措施: Celecoxib 200mg (Drug)
Minocycline
Minocycline 100 mg twice a day
干预措施: Minocycline 100mg (Drug)
结局指标
主要结局
Cognition: MATRICS Consensus Cognitive Battery (MCCB) scores
时间窗: six weeks
Change in MCCB scores. The MCCB is comprised of 9 tests that reflect 7 dimensions of neurocognitive dysfunction in schizophrenia, including: Speed of Processing, Attention/Vigilance, Working Memory, Verbal Learning, Visual Learning, and Reasoning and Problem Solving and Social Cognition. The MCCB scoring program yields the domain scores and a composite score which are standardized to the same T-score measurement scale with a mean of 50 and an SD of 10 based upon the normative data.
Symptom severity: Positive and Negative Syndrome Scale score
时间窗: six weeks
Change in the Positive and Negative Syndrome Scale score, which comprises 33 items which can be scored from 1 (absent) to 7 (extreme), evaluating an array of symptoms including positive, negative, neuromotor, depressive and anxious, and involves the use of data from patient reports, caregiver reports, and clinical observations. The total score is the sum or all the items, the maximum score is 231. The higher values represent a worse outcome
次要结局
未报告次要终点