CTRI/2024/07/070353尚未招募3 期
ACETYL-L-CARNITINE as augmentation therapyin Clozapine resistant Schizophrenia - NI
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •INCLUSION CRITERIA
- •1. Patients (Male & Female) in the age group of 18 to 60 years.
- •2. Patients suffering from schizophrenia as per ICD-11.
- •3. Patients who fulfilled the criteria for TRS will be selected for study.
- •For the purpose of the study treatment resistant schizophrenia is
- •defined as:[26]
- •a. Failure to respond to = 2 antipsychotic.
- •b. Treatment failure of =1 antipsychotic + prospective treatment failure
- •with another antipsychotic (different from the one previously failed).
- •c. Dose and duration: each treatment with > 600 chlorpromazine
- •equivalents per day for > 6 weeks.
- •d. Lack of improvement in a reducing CGI > 4 and GAF < 50.
- •e. The duration of illness should be at least two years.
- •f. In addition, the patients should be resistant to clozapine provided at
- •adequate dose for an adequate duration.
- •4. Medically stable patient will be included.
- •5. Patients who will be accompanied by reliable informants.
- •6. Patients and informants who willingly participate in the study and take
- •ALC as augmentation therapy for TRS.
- •7. Patients giving written informed consent will be included.
排除标准
- •EXCLUSION CRITERIA
- •The patients with following characteristics were excluded from study:
- •1. Patients who have associated medical problems, which could affect the course of illness. eg. cerebrovascular diseases, renal diseases,
- •pulmonary disease etc.
- •2. Patients of co-morbid alcohol and substance use disorder except nicotine.
- •3. Pregnant and breastfeeding females.
- •4. Violent unmanageable patients.
- •5. Intellectual disability patients.
- •6. Patients unable to cooperate on test of MoCA on first followup will be considered non eligible.
- •7. Patients hypersensitive to ALC.
研究者
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