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IRCT201410126418N3 IRCT 2015-02-27 Isfahan University of Medical Sciences Tamoxifen Effects in Acute mania in Youth Investigation of efficacy of lithium and tamoxifen in the treatment of acute mania in bipolar affective disorder. 2014-09-23 anticipated 44 Complete https://irct.ir/trial/6859 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A mania in youth. Intervention 1: intervention goup are randomly allocates in to lithium (1-1/2meq/lit)+tamoxifen(40mg/day)(Group A)for a3weeks.The principle measures of outcomeare the Young Mania Rating Scale and Child Depresion Inventory scale,and measure evaluate weekly. Intervention 2: Control goup are randomly allocates into lithium (1-1/2meq/lit)+placebo(Group B)for a3weeks.The principle measures of outcomeare the Young Mania Rating Scale and Child Depresion Inventory scale,and measure evaluate weekly.
public Elham Fallah
Shahid Mahdavi St., Bahar Av., HezarJarib St. , Isfahan City
Isfahan Iran (Islamic Republic of) +98 31 3668 1836 elhamfallah51@yahoo.com Isfahan University of Medical Seiences scientific Dr.Soroor Arman
Sheikh Koleini St., HezarJarib St., Isfahan City
Isfahan Iran (Islamic Republic of) +98 312222135 arman@med.mui.ac.ir Isfahan University of Medical Sciences Iran (Islamic Republic of) Inclusion Criteria Consistent 9-22 years old with current manic episode (with or without psychotic feature) as diagnosed by means of the structured clinical interview for Axis I DSM-IV disorders-Patient version (SCDI-P).A score of at least 20 points on the Young Mania Rating Scale was required representing at least a moderate-to- severe mania. Exclushon Criteria: Neurological or other medical impairement- The need for ongoing treatment with other psychoactive medications and/or current substance dependence- Mental Retardation (IQ<70)- History of renal or liver function impairements- History of coagulopathy, 9 years 22 years Both F31.1-F31. A disorder characterized by two or more episodes in which the patient's mood and activity levels are significantly disturbed, this disturbance consisting on some occasions of an elevation of mood and increased energy and activity (hypomania or mania) and Treatment - Drugs Treatment - Drugs intervention goup are randomly allocates in to lithium (1-1/2meq/lit)+tamoxifen(40mg/day)(Group A)for a3weeks.The principle measures of outcomeare the Young Mania Rating Scale and Child Depresion Inventory scale,and measure evaluate weekly. Control goup are randomly allocates into lithium (1-1/2meq/lit)+placebo(Group B)for a3weeks.The principle measures of outcomeare the Young Mania Rating Scale and Child Depresion Inventory scale,and measure evaluate weekly. Young Mania Rating Scale. Timepoint: First Week-Second Week-Third Week. Method of measurement: Questionair. Child Depression Rating Scale. Timepoint: First Week-Second Week- Third Week. Method of measurement: Questionair. Isfahan University of Medical Sciences Approved 2014-09-17 Medicin college of Isfahan University of Medical Sciences Hezar Jarib St.-Isfahan University of Medical Sciences Isfahan Iran (Islamic Republic of)