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IRCT20090117001556N143 IRCT 2022-05-26 Tehran University of Medical Sciences Pentoxifylline for the treatment of negative symptoms of Schizophrenia Pentoxifylline as an adjuvant therapy in the treatment of negative symptoms of Schizophrenia: A randomized double blind and placebo controlled clinical trial 2022-06-22 anticipated 50 Complete https://irct.ir/trial/63756 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups). The best way to create randomization is to use random allocation. Random allocation in clinical trial studies refers to the process of randomly dividing participants into different groups. Randomization gives each participant an equal chance to participate in each group. Successful randomization requires that researchers and study participants be unable to predict the type of intervention received, Blinding description: The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process. 2-3 Schizophrenia. Intervention 1: Intervention group: Patients (25 participants) treated with risperidone 4-6 mg per day + Pentoxifylline 400 mg twice a day for 8 weeks. Intervention 2: Control group: Patients (25 participants) treated with risperidone 4-6 mg per day + placebo twice a day for 8 weeks. Yes - There is a plan to make this available What will be shared: The data will be distributed through final report When: 5 years from 2023 to 2028 To whom: Academic researchers Conditions: Users should cite the resource of data Where to obtain: Prof Shahin Akhondzadeh How to obtain: By E-mail Comments:
public Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Shahin Akhondzadeh
Roozbeh Hospital, South Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1333715914 +98 21 5541 2222 s.akhond@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of schizophrenia based on DSM-5 Age between 18-60 At least 2 years have been passed since the diagnosis Have been stable with risperidone treatment for at least 2 months <14 HDRS score >15 PANSS score for negative symptoms 18 years 60 years Both Head trauma History of shock therapy during the last three months Neurosurgery Diagnosis of acute or chronic systemic disease History of drug allergy to risperidone or pentoxifylline Alcohol or drug addiction in the last 6 months Suicidal ideation Pregnancy or lactation IQ less than 70 based on the diagnosis of a psychiatrist. F20 Schizophrenia Treatment - Drugs Placebo Intervention group: Patients (25 participants) treated with risperidone 4-6 mg per day + Pentoxifylline 400 mg twice a day for 8 weeks. Control group: Patients (25 participants) treated with risperidone 4-6 mg per day + placebo twice a day for 8 weeks. Severity of schizophrenia. Timepoint: Baseline and weeks 4 and 8. Method of measurement: By Positive and Negative Syndrome Scale (PANSS). Tehran University of Medical Sciences Approved 2022-03-19 School of Medicine Ethics Committee, Tehran University of Medical Sciences School of Medicine, Tehran University of Medical Sciences, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)