]>
IRCT20090117001556N133 IRCT 2020-12-12 Tehran University of Medical Sciences L-Theanine as an adjuvant therapy for chronic schizophrenia L-Theanine as an adjuvant therapy added to Risperidone for the treatment of patients with chronic schizophrenia: A randomized double blind and placebo controlled clinical trial 2021-01-20 anticipated 50 Complete https://irct.ir/trial/52906 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), 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: Risperidone (Johnson co. Belgium) 2 mg, three times/day + L-Theanine (Institute of Medicinal Plants) 400 mg everyday for 8 weeks. Intervention 2: Control group: Risperidone (Johnson co. Belgium) 2 mg, three times/day + Placebo tablet everyday 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 2021 to 2026 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 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 Prof. 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. Minimum score of 60 based on PANSS. Age range: 18-55 years. At least, 2 years have passed since the onset of the disorder. 18 years 55 years Both Diagnosis of another disorder in axis II. Existence of a significant neurological or organic disease. IQ less than 70 based on interviewer clinical suspicion. Substance/drug dependence during the last 6 months (except nicotine and caffeine). Use of antipsychotics during past 1 week or long-term antipsychotics during past 1 month. Receiving ECT during the last 2 weeks. Abnormal endocrine activity. Abnormal kidney and liver function. History of trombosis and embolia. History of abnormal bleeding. F20 Schizophrenia Treatment - Drugs Placebo Intervention group: Risperidone (Johnson co. Belgium) 2 mg, three times/day + L-Theanine (Institute of Medicinal Plants) 400 mg everyday for 8 weeks. Control group: Risperidone (Johnson co. Belgium) 2 mg, three times/day + Placebo tablet everyday 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 2020-08-22 Ethics Committee of Tehran University of Medical Sciences Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)