Randomized controlled trial metabolic effects of adding Topiramate on Aripiprazole in bipolar patients under age 18

Metabolic effects of adding Topiramate on Aripiprazole in bipoar patients under age 18

Double blinded randomized clinical trial,parallel group, randomized, phase3 on 40 bipolar patients betwren age 6-18 years,randomization was done with computer randomization.

This trial will be conducted during 3 phases(0,1,3 month) in new bipolar patients between age 6-18 that be visited in outpatient units or admission wards of department of child psychiatry of Isfahan University of Medical Sciences.all of participants, health care providers(that are involved in offering drug or placebo to participants) and data collectors and assessors will be blinded with similarity in form and shape of drug and placebo and numerical codes for each participants instead of name in all time of study.

Inclusion criteria: 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 or weight during recent 3 month before study,lack of history of allergic reaction to topiramate and lack of history of renal insufficiency or renal stone. Exclusion criteria: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.

Intervention group will recieve drug combination of Aripiprazole and Topiramate(drug A)and control group will recieve Aripiprazole and placebo(drug B).

In the begining of study and in end of month 1 and 3, metabolic indices of patients such as height,weight, waist circumference, TG, BMI, Fasting insulin, Hb A1C, HDL, LDL, FBS, Cholesterol will be assessed as severity of bipolar disorder.

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.

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.