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IRCT20120314009297N5 IRCT 2018-05-14 Mazandaran University of Medical Sciences The effect of nano curcumin in male patients with residual schizophrenia Study of the efficacy and safety of nano curcumin as an adjuvant to antipsychotics in male patients with residual schizophrenia: A randomized, double-blind, placebo-controlled trial 2018-03-21 anticipated 40 Complete https://irct.ir/trial/30767 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on random numbers and 1: 1 ratio in treatment group and control group, Blinding description: Curcumin and placebo capsules are completely similar in terms of color, size, smell and taste produced by a completely similar manufacturing and packagings. Patients were randomly tested in groups. Until the end of the study, no patient or study persons are aware of which drug the patient receives. And anybody other than those who are defective in the study is aware. 3 Schizophrenia with residual symptoms. Intervention 1: Intervention group: Standard treatment regimen with two nanocurcumin capsule 80mg (sinacurcumin@) in two divided dose for four months. Intervention 2: Control group: Standard treatment regimen with two placebo capsule that are similar to nanocurcumin capsules for odor, taste, size and color in two divided dose. No - There is not a plan to make this available Justification or reason for not sharing IPD is I have not decided yet - its release plan is still unclear
public Narjes Hendouei
20th Km Farahabad Road, Payambar Azam Academic Complex
Sari Iran (Islamic Republic of) 33971-48157 +98 11 3354 2472 hendoieen@yahoo.com Mazandaran University of Medical Sciences scientific Narjes Hendouei
20th Km Farahabad Road, Payambar Azam Academic Complex
Sari Iran (Islamic Republic of) 33971-48157 +98 11 3354 2472 hendoieen@yahoo.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 18-65 years old men With the diagnosis of schizophrenia based on DSM-5 criteria for at least two years and despite the anti-psychotic drug treatment, they are still symptomatic. They are treated with antipsychotics for at least one year and In the last month, the type and dosage of their antipsychotic drugs remain constant. If receiving medications such as mood stabilizer or anti depressants, their type and dosage will remain constant from one month before the start of the study and during the study. 18 years 65 years Male Patients with acute suicidal behavior or history of suicide attempt last year, the presence of psychiatric disorders such as schizoaffective or other psychotic disorders, Mental retardation or other cognitive impairment, bipolar disorder and depression, anxiety disorders such as current panic disorder or obsessive-compulsive disorder, post traumatic stress disorder, eating disorder. History of drug dependence (DSM-5 drug dependency criterion) or substance abuse during the three months prior to the onset of the study or positive urine specimen testing at the start of the study. ECT therapy in the past six months. People with thoughts or attempted to harm themselves or others at baseline and at 6 months before the start of the study. Mental retardation Patients with neurological disorders such as uncontrolled seizure, dementia, head injury, seizure disorder (other than febrile) and neurodegenerative diseases (such as Alzheimer's disease, Parkinson's disease, stroke, and multiple sclerosis) Patients with uncontrolled illnesses such as cardiovascular disease-liver and kidney failure-types of malignancies-autoimmune diseases, endocrine disorders such as diabetes, and hematological disorders, chronic diseases such as cardiovascular disease, history of myocardial infarction, severe hypertension, excessive overweight due to endocrine disorder, unstable thyroid disease, biliary diseases, consuming sex hormones, cerebrovascular diseases, benign prostatic hypertrophy, glaucoma, asthma, COPD, chronic fatigue syndrome, Fibromyalgia and any unstable medical condition. Receiving anticoagulant and antiplatelet treatments or having hemorrhagic risk factors, having an infectious disease during last month, the likelihood of not being able to complete a study because of a serious illness. No more than once a week to take analgesics and do not use turmeric and curcumin supplements and no use of turmeric in the diet. Sensitivity to the curcumin plant or any of the available placebo compounds. History of NMS Patients treated with anticholinergic drugs (except of biperiden and trihexyphenidyl) according to drugs on the Anticholinergic Burden scale (ACB) F20.5 Residual schizophrenia Treatment - Drugs Placebo Intervention group: Standard treatment regimen with two nanocurcumin capsule 80mg (sinacurcumin@) in two divided dose for four months. Control group: Standard treatment regimen with two placebo capsule that are similar to nanocurcumin capsules for odor, taste, size and color in two divided dose. Score of general, positive and negative symptoms with Positive and Negative Symptom Scale (PANSS). Timepoint: At baseline and the end of each month. Method of measurement: Positive and Negative Symptom Scale (PANSS). Score of change in severity of illness based on Clinical Global Impression – Improvement (CGI-I). Timepoint: At baseline and the end of each month. Method of measurement: Clinical Global Impression -Improvement (CGI-I) score. Score of severity of illness based on Clinical Global Impression of Severity (CGI-S). Timepoint: At baseline and at the end of each months. Method of measurement: Clinical Global Impression off Severity (CGI-S). Score of depression symptoms based on Calgary Depression Scale for Schizophrenia. Timepoint: At baseline and the end of each month. Method of measurement: Calgary Depression Scale for Schizophrenia. Score of improvement in cognitive symptoms based on Brief Assessment of Cognition in schizophrenia. Timepoint: At baseline and the end of the each months. Method of measurement: Brief Assessment of Cognition in schizophrenia. Score of SAS for extra pyramidal side effects. Timepoint: At baseline and weekly. Method of measurement: Simpson-Angus Scale (SAS). Score of Barnes Akathisia Rating Scale (BARS). Timepoint: At baseline and weekly. Method of measurement: Barnes Akathisia Rating Scale (BARS). Score of Abnormal Involuntary Movement Scale (AIMS). Timepoint: At baseline and weekly. Method of measurement: Abnormal Involuntary Movement Scale (AIMS). Lipid profile. Timepoint: At baseline and the end of study. Method of measurement: ELIZA Kit. Fasting blood glucose. Timepoint: At baseline and the end of study. Method of measurement: ELIZA Kit. Weight. Timepoint: At baseline and the end of each month. Method of measurement: Scale. Mazandaran University of Medical Sciences Approved 2018-04-18 کمیته اخلاق دانشگاه علوم پزشکی مازندران Moallem street, Moallem square, Vice chancellor for research Sari Mazandaran Iran (Islamic Republic of)