Efficacy and safety of ferrous sulphate add-on standard treatment regimen for children with attention-deficit hyperactivity disorder in 7- to 14 year-Old without iron deficiency and anemia : A 12 weeks randomized, open-label, parallel group Study

Mazandaran University of Medical Sciences0 个研究点目标入组 38 人开始时间: 待定最近更新: 2018年5月21日

试验速览

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•7-14 years old children
•Diagnosed attention deficit hyperactivity disorder children by two psychiatrists and based on DSM-V and without iron deficiency and anemia (Serum ferritin above 15 µg /L and serum hemoglobin equal to or greater than 11 g /dl )
•All patients are on standard treatment regimen for attention-deficit hyperactivity disorder for at least 3 months and a stable dose for at least 1 month.

•Acute phase of the disease
•Psychiatric comorbidity as defined by DSM-V (bipolar disorder, Major depressive disorder)
•Mental retardation
•Neurological diseases such as delirium, seizure, traumatic brain injury
•Current significant unstable medical illness (such as unstable cardiac disease, hepatic or renal impairment, evidence or history of malignancy or any significant hematological, endocrine)/ HIV infection / abnormalities on physical examination, vital signs, electrocardiogram (ECG), or clinical laboratory values
•Hypersensitivity to iron sulphate
•Previous treatment with any enriched medical products with iron at least 2 months before the initiation
•Unwillingness of the patient or his guardian to participate in the study

发起方