ACETYL-L-CARNITINE as augmentation therapy in Clozapine resistant Schizophrenia

Government Medical College Patiala1 个研究点分布在 1 个国家目标入组 78 人开始时间: 2024年7月20日最近更新: 2024年7月8日

试验速览

阶段: 3 期
状态: 尚未招募
发起方: Government Medical College Patiala
入组人数: 78
试验地点: 1
主要终点: Improvement in illness severity

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Schizophrenia is a chronic disorder associated with wide range of manifestations in several psychopathological dimensions such as positive, negative, disorganized, cognitive and affective symptoms. Up to 2/3rd of patients achieve good outcomes with antipsychotic treatment whereas 1/3rd show poor outcome. Thus, 30% to 40% of patients have Treatment Resistant Schizophrenia (TRS) characterized by inadequate response to treatment with two or more trials of dopaminergic antipsychotics (> 600 chlorpromazine equivalents); and illness duration more than 2 years. The antipsychotic Clozapine is the drug of choice for management of TRS. Many patients however do not respond to Clozapine monotherapy and require to be administered adjunctive treatments. They have high risk of bioenergetic and cognitive dysfunction. Acetyl-L-carnitine is involved in the bioenergetic pathways and it may be beneficial in cognitive dysfunction. The aim of the study is to assess therapeutic efficacy of Acetyl-L-Carnitine as an augmenting agent in clozapine resistant schizophrenia. 78 participants will be recruited using consecutive purposing sampling in a hospital based prospective, parallel group, open label study. Group I (n=39) will be given clozapine Â± other antipsychotics + acetyl-L-carnitine and Group II (n=39) will be given clozapine Â± other antipsychotics + placebo. The sociodemographic and clinical data will be recorded. Primary outcomes of treatment (efficacy of treatment as assessed by severity of symptoms and functioning) will be assessed on Positive and Negative Syndrome Scale (PANSS), Clinical Global Impressions Scale (CGI), Global Assessment of Functioning (GAF) and Montreal Cognitive Assessment (MoCA). Secondary outcomes will be assessed for antipsychotic side effects on Abnormal Involuntary Movement Scale (AIMS) and Barnes Akathisia Rating Scale (BARS), adverse drug effects of ALC on adverse event scale and cost effectiveness. Data thus extracted will be analyzed by appropriate statistical methods with P value â‰¤0.05 being statistically significant.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

入排标准

年龄范围: 18.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•INCLUSION CRITERIA
•Patients (Male & Female) in the age group of 18 to 60 years.
•Patients suffering from schizophrenia as per ICD-
•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 â‰¥ 2 antipsychotic.
•Treatment failure of â‰¥1 antipsychotic + prospective treatment failure with another antipsychotic (different from the one previously failed).
•Dose and duration: each treatment with > 600 chlorpromazine equivalents per day for > 6 weeks.
•The duration of illness should be at least two years.
•In addition, the patients should be resistant to clozapine provided at adequate dose for an adequate duration.
•Medically stable patient will be included.
•Patients and informants who willingly participate in the study and take ALC as augmentation therapy for TRS.
•Patients giving written informed consent will be included.

排除标准

•EXCLUSION CRITERIA The patients with following characteristics were excluded from study:
•Patients who have associated medical problems, which could affect the course of illness.
•cerebrovascular diseases, renal diseases, pulmonary disease etc.
•Patients of co-morbid alcohol and substance use disorder except nicotine.
•Pregnant and breastfeeding females.
•Violent unmanageable patients.
•Intellectual disability patients.
•Patients unable to cooperate on test of MoCA on first followup will be considered non eligible.
•Patients hypersensitive to ALC.