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IRCT20210622051665N1 IRCT 2021-07-25 University of social welfare and rehabilitation sciences Topiramate’s effectiveness on weight reduction and metabolic syndrome in obese patients with schizophrenia and schizoaffective Topiramate’s effectiveness on weight reduction and metabolic syndrome in obese patients with schizophrenia and schizoaffective 2020-01-21 anticipated 70 Complete https://irct.ir/trial/57051 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The collected samples were randomly divided into two groups based on the random sequence created in the Random allocation software to the drug and placebo, Blinding description: In this study, sampling is performed by the researcher and the interventions are performed by the nurse. Also, the sampler does not know that the sample is part of the control or intervention group.The patients in this study are also unaware of being in the intervention or control group. 3 Schizophrenia,Schizoaffective. Intervention 1: Patients were randomly divided (in alphabetical order) into two groups of men and women, and each of these groups was divided into intervention and control groups. A total of 33 patients entered the intervention group. In order to observe the ethical issues of diet and the amount of appropriate daily activity, the condition of all patients was observed based on consultation with a nutritionist and similar conditions were established in the two groups of topiramate and control. Topiramate 50 mg tablets of Aria Pharmaceutical Company were packaged in the same shape as tablets and presented to the patients by the center nurse. Initially one capsule daily in the morning and after one week, two daily capsules (one capsule in the morning and one capsule in the evening) will be given until the end of week 12. Intervention 2: Control group: Patients were randomly divided (in alphabetical order) into two groups of men and women, and each of these groups was divided into intervention and control groups. A total of 33 patients entered the intervention group. In order to observe the ethical issues of diet and the amount of appropriate daily activity, the condition of all patients was observed based on consultation with a nutritionist and similar conditions were established in the two groups of topiramate and control. The placebo pill was packaged in the same shape as the tablets and presented to the patients by the center nurse. Initially one capsule daily in the morning and after one week, two daily capsules (one capsule in the morning and one capsule in the evening) will be given until the end of week 12. 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 more information.
public Hamidreza Kamravan
Tehran, Shahreri, Shahid Rastegar Boulevard
Tehran Iran (Islamic Republic of) 1345935775 +98 21 6683 4793 kamravan@gmail.com University of social welfare and rehabilitation sciences scientific Hamidreza Kamravan
Azarbayejan, Foad moosavi street, bani asadi Avenue, No 7.
Tehran Iran (Islamic Republic of) 1345935775 +98 21 6683 4793 kamravan@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Age between 18 to 65 years BMI above 27 Patients with schizophrenia or schizoaffective disorder receiving a second-generation antipsychotic drug Obtaining informed consent from the patient and the patient's legal guardian 18 years 65 years Both Diabetis Pregnancy or breastfeeding Patients with heart failure Patients with kidney disease Hypersensitivity to topiramate Treatment - Drugs Placebo Patients were randomly divided (in alphabetical order) into two groups of men and women, and each of these groups was divided into intervention and control groups. A total of 33 patients entered the intervention group. In order to observe the ethical issues of diet and the amount of appropriate daily activity, the condition of all patients was observed based on consultation with a nutritionist and similar conditions were established in the two groups of topiramate and control. Topiramate 50 mg tablets of Aria Pharmaceutical Company were packaged in the same shape as tablets and presented to the patients by the center nurse. Initially one capsule daily in the morning and after one week, two daily capsules (one capsule in the morning and one capsule in the evening) will be given until the end of week 12. Control group: Patients were randomly divided (in alphabetical order) into two groups of men and women, and each of these groups was divided into intervention and control groups. A total of 33 patients entered the intervention group. In order to observe the ethical issues of diet and the amount of appropriate daily activity, the condition of all patients was observed based on consultation with a nutritionist and similar conditions were established in the two groups of topiramate and control. The placebo pill was packaged in the same shape as the tablets and presented to the patients by the center nurse. Initially one capsule daily in the morning and after one week, two daily capsules (one capsule in the morning and one capsule in the evening) will be given until the end of week 12. BMI>27. Timepoint: before study and in weeks 4,8 and 12. Method of measurement: measure height and weight. Measure abdominal circumference. Timepoint: before study and in weeks 4,8 and 12. Method of measurement: Tape meter. FBS. Timepoint: before the study and in weeks 4,8 and 12. Method of measurement: Blood sample and lab result. Total cholesterol. Timepoint: before the study and in weeks 4,8 and 12. Method of measurement: Blood sample and lab result. Triglyceride. Timepoint: before the study and in weeks 4,8 and 12. Method of measurement: Blood sample and lab result. University of social welfare and rehabilitation sciences Approved 2020-01-15 Ethics committee of Social Welfare and Rehabilitation Sciences University of Medical Sciences kodakyar Ave., daneshjo Blvd.,Evin Tehran Tehran Iran (Islamic Republic of)