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IRCT20200606047668N1 IRCT 2020-06-20 Esfahan University of Medical Sciences Metabolic effects of adding Topiramate on Aripiprazole in bipolar patients under age 18 Randomized controlled trial metabolic effects of adding Topiramate on Aripiprazole in bipolar patients under age 18 2020-04-21 anticipated 38 Complete https://irct.ir/trial/48793 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Online randomization with random assignment by blocks aproach will be done by online RESEARCH RANDOMIZER software and then each number on each group of study will recive a new code so allocation concealment will be carried out, Blinding description: Paricipants in both intervention and control group will be blinded about drug or placebo with similarity in shape of drug and placebo.principle investigator will be blinded with randomal placing the participants in both control and intervention group so give each paticipant a numerical code.health care providers offer the drug and placebo base on A and B codes to participants and data callectors and outcome assessors will be blinded because they will collect data and assess them without any information about drug or placebo type. 3 Condition 1: Bipolar disorder. Condition 2: Metabolic syndrome. Intervention 1: Intervention group: Topiramate tablet (TOPIRAMATE-ARYA 25MG TAB) with dose 25-100mg daily, once daily orally for 3 months. Intervention 2: Control group: placebo tablet(School of Pharmacy and Pharmaceutical SciencesSchool of Isfahan University of Medical Sciences) contains starch and calcium diphosphate with dose 1-4 tablet per day orally and once daily. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Mostafa Haghshenas
Hezar jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 4572 2109 Tamasha_jums@yahoo.com Esfahan University of Medical Sciences scientific Mostafa Haghshenas
Hezar Jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 4572 2109 Tamasha_jums@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Consent to participate in the study by completing the informed consent form by patient and family. Lack of any chronic physical illness. Negative history of recieving any antypsychotic drug or mood stabilizers or drugs that could change appetite during recent 3 month before study Lack of history of allergic reaction to topiramate Lack of history of renal insufficiency or renal stone Age between 6-18 years 6 years 18 years Both patient or family unwillingness to stay in study Need to ECT treatment during study Any unexpected new physical illness that could change medical care of patient F31 E90 Bipolar affective disorder Nutritional and metabolic disorders in diseases classified elsewhere Treatment - Drugs Placebo Intervention group: Topiramate tablet (TOPIRAMATE-ARYA 25MG TAB) with dose 25-100mg daily, once daily orally for 3 months Control group: placebo tablet(School of Pharmacy and Pharmaceutical SciencesSchool of Isfahan University of Medical Sciences) contains starch and calcium diphosphate with dose 1-4 tablet per day orally and once daily. Bipolar disorder. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Young mania rating scale. Fasting blood glucose. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit. Triglyceride. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit. Glycated hemoglobin. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit. Cholestrol. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit. Low density lipoprotein. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit. High density lipoprotein. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit. Fasting insulin. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Lab kit. Blood pressure. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: sphygmomonometer. Waist circumference. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Standard meter. Weight. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Standard scale. Height. Timepoint: Before intervention and 1,3 months after intervention. Method of measurement: Standard meter. Esfahan University of Medical Sciences Approved 2020-06-19 Isfahan University of Medical Sciences Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)