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IRCT138904014236N1 IRCT 2006-03-21 Mashad university of medical sciences Effect of Topiramate in treatment of chronic schizophrenia Effectiveness of Topiramate augmentation compared with placebo in chronic schizophrenia admitted to Ebnesina and Hejaze Hospitals in Mashad 2006-03-21 anticipated 80 Complete https://irct.ir/trial/4497 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A Schizophrenia. Intervention 1: Optimum dosage of clozapine was continued for all participants for 4 weeks and then topiramate was gradually added to their ongoing treatment. Topiramate was prescribed at a dose of 50 mg on day 0. Every 2 days, the dose was increased by 50 mg/day and based on tolerability. The maximum dose allowed was 150 mg twice a day. Subjects were maintained on topiramate for 8 weeks, thereafter they were tapered and discontinued gradually in 1 week. They were followed for an additional 4 weeks on their stable antipsychotic medications. Intervention 2: Optimum dosage of clozapine was continued for all participants for 4 weeks and then placebo (was as same as topiramate in the shape and color) was gradually added to their ongoing treatment. Subjects were maintained on placebo for 8 weeks, thereafter they were tapered and discontinued gradually in 1 week. They were followed for an additional 4 weeks on their stable antipsychotic medications.
public Fatemeh Behdani
Ebne Sina Hospital
Mashad Iran (Islamic Republic of) +98 51 1604 3772 behdanif@mums.ac.ir Mashad University of Medical Sciences scientific Paria Hebrani
Horre Ameli Ave., Ebne Sina Hosphtal
Mashad Iran (Islamic Republic of) +98 51 1761 6158 اhebranip@mums.ac.ir Mashad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria 1. All the patients who meet the full criteria of chronic and treatment resistant schizophrenia disorder, based on DSMIV-TR 2. Ages of subjects were between 25 to 65 years 3. All patients were hospitalized for at least 6 month before the study 4. All patients were being treated with Clozapin Exclusion criteria 1. Chronic diseases including diabetes, hypertension, history of kidney stone, epilepsy and substance abuse 2. An ongoing medical treatment 3. Elevated PANSS score up to 30% 4. Adverse effects associated with therapy including dizziness, agitation, hypertension, allergy to medications 5. Medical problems need to be treated such as diarrhea, urinary infection, cardiovascular disease, and trauma. 6. Temporary or permanent discharge from hospital while in study 7. Developing new psychiatric symptoms such as manic or hypomanic episode, panic attack 25 years 65 years Both F20 Schizophrenia Treatment - Drugs Placebo Optimum dosage of clozapine was continued for all participants for 4 weeks and then topiramate was gradually added to their ongoing treatment. Topiramate was prescribed at a dose of 50 mg on day 0. Every 2 days, the dose was increased by 50 mg/day and based on tolerability. The maximum dose allowed was 150 mg twice a day. Subjects were maintained on topiramate for 8 weeks, thereafter they were tapered and discontinued gradually in 1 week. They were followed for an additional 4 weeks on their stable antipsychotic medications. Optimum dosage of clozapine was continued for all participants for 4 weeks and then placebo (was as same as topiramate in the shape and color) was gradually added to their ongoing treatment. Subjects were maintained on placebo for 8 weeks, thereafter they were tapered and discontinued gradually in 1 week. They were followed for an additional 4 weeks on their stable antipsychotic medications. Positive symptoms. Timepoint: week 0, 4, 8, 12 and 17. Method of measurement: Positive and Negative Syndrome Scale (PANSS). Negative Symptoms. Timepoint: week 0, 4, 8, 12 and 17. Method of measurement: Positive and Negative Syndrome Scale(PANSS). General Psychopathology. Timepoint: week 0, 4, 8, 12 and 17. Method of measurement: Positive and Negative Syndrome Scale(PANSS). Side effects. Timepoint: week 4, 8, 12 and 17. Method of measurement: checklist. Mashad university of medical sciences Approved 2006-02-05 Mashad university of medical sciences Daneshgah Ave. Ghoreishi Building Mashad Iran (Islamic Republic of)