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IRCT20181117041682N2 IRCT 2019-03-10 Ahvaz University of Medical Sciences Evaluation the Effect of Adding Galantamine to Second Generation Antipsychotics Evaluation the Effect of Adding Galantamine to Second Generation Antipsychotics, on Negative Symptoms of Schizophrenia 2019-01-21 anticipated 28 Complete https://irct.ir/trial/36511 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on the method of the permutation blocks of size 4, individuals are randomly divided into two groups. Samples will be divided into two experimental and control groups based on permutation blocks (blocks of size 4). It will be listed according to six possible ways (AABB, ABAB, ...) randomly and the arrangement of receiving intervention will be determined accordingly, Blinding description: the placebo is similar to Galantamin in shape, color, smell, and taste and will be available at the Faculty of Pharmacy, Ahwaz University of Medical Sciences. The medication will be prescribed by the assistants and given to the patients by the nurses at a psychiatric ward. The project executor is not aware of the prescriptions in each group. Also, patients are unaware of their treatment. 2-3 Schizophrenia. Intervention 1: Intervention group: In the case group in addition use of second-generation anti-psychoactive agent Galantamin is added. initially, prescribing gallantamine will begin with a dose of 4 mg twice daily, which will gradually be increased to 12 mg twice a day over a period of four weeks and will continue until the end of week 8. . Intervention 2: Control group: More over receiving second-generation anti-psychoactive agent, also placebo is added. Placebo is a pill that looks like Galantamine in terms of its shape, color, smell and taste. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Ahmad Fakhri
Ahvaz Golestan Hospital, Golestan Blvd,Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3374 3038 Dr.fakhri@gmil.com Ahvaz University of Medical Sciences scientific Zahra Roshandel
Ahvaz Golestan Hospital, Golestan Blvd,Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3374 3038 roshandelzahra@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of schizophrenia based on the DSM-5 Age of 18-55 years Get at least one second-generation anti-psychotic drug within the dose range Having a score of at least 15 in the subgroup of negative marks on the PANSS assessment scale 18 years 55 years Both Other disorders in axis 1 The presence of cardiac disorders, liver disorders, kidney disorders and etc. History of allergy to second-generation antipsychotics Positive test for amphetamines or methamphetamines at initiate time of admission Pregnancy or breastfeeding Simultaneous treatment with anticholinergic drugs The existence of suicidal thoughts F20 Schizophrenia Treatment - Drugs Treatment - Drugs Intervention group: In the case group in addition use of second-generation anti-psychoactive agent Galantamin is added. initially, prescribing gallantamine will begin with a dose of 4 mg twice daily, which will gradually be increased to 12 mg twice a day over a period of four weeks and will continue until the end of week 8. . Control group: More over receiving second-generation anti-psychoactive agent, also placebo is added. Placebo is a pill that looks like Galantamine in terms of its shape, color, smell and taste. Negative sign of Schizophrenia. Timepoint: at the start of treatment, weeks 2, 4 and 8 of treatment. Method of measurement: Oveall scale score PANS. Ahvaz University of Medical Sciences Approved 2018-11-27 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Golestan Blvd, Ahvaz, Khoozestan Ahvaz Khouzestan Iran (Islamic Republic of)