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IRCT20210831052351N1 IRCT 2021-11-16 University of social welfare and rehabilitation sciences The effect of Celecoxib in the treatment of Schizophrenia Evaluation of efficacy of celecoxib as add on to risperidone to reduce positive , negative and cognitive symptoms in schizophrenic patients in active phase: a double-blind, randomized and placebo-controlled clinical trial 2021-11-06 anticipated 52 Complete https://irct.ir/trial/58445 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization of software www.sealedenvelope.com/simple-randomiser/v1/lists will be used. Randomization of the unit is done in a block method with a block size of 4. For each of the 6 possible cases for the quadruple block, the numbers are assigned as follows: 2 (ABAB), 1 (AABB), 3 (ABBA), 4 (BBAA), 5 (BABA), 6 (BAAB) With the help of a table of random numbers, the numbers between 1 and 6 are selected and the treatment allocation list is determined according to each number. To execute the generated random sequence, the method of hiding encoded boxes or cans is used. In this method, the cans are numbered according to a random sequence and inside the boxes, the desired intervention (drug) or a sheet on which the random allocation is written, is provided to the operator with the condition that the boxes are completely sealed. And the researcher assigns them to the standard intervention and treatment group based on the order of patients' admission. Tools: Creating a random sequence of 4 random hiding blocks to execute a random sequence on the study participants. How to make: Randomly select the block and read the letters from right to left. More about this source textSource text required for additional translation information Send feedback Side panels, Blinding description: Participants (after obtaining consent) which includes two groups of celecoxib recipients and placebo recipients (with main treatment), project researcher, health care personnel responsible for patient care, a person who examines participants for inclusion and exclusion criteria and enrolls them in the study, The person assigning participants to the groups will be the outcome evaluator, the data analyst will be separate and independent. 3 Schizophrenia. Intervention 1: Intervention group: Patients with schizophrenia in the acute phase treated with 6 mg of risperidone manufactured by Abidi Company, which will receive 400 mg of celecoxib (200 mg twice daily) produced in Razak Laboratory for 8 weeks. Intervention 2: Control group: Patients with schizophrenia treated with risperidone made by Abidi Company who will receive a placebo similar to celecoxib from Razak Laboratory with magnesium stearate content (capsules, daily dose) for 8 weeks. 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 Farahnaz Moradzadeh
Razi Educational and Therapeutic Psychiatry Center, Shahid Rastegar Blvd., Tehran Varamin Hwy
Tehran Iran (Islamic Republic of) 1866958891 +98 21 3340 1220 farahnaz_moradzadeh66@yahoo.com University of social welfare and rehabilitation sciences scientific Farahnaz Moradzadeh
Razi Educational and Therapeutic Psychiatry Center, Shahid Rastegar Blvd., Tehran Varamin Hwy
Tehran Iran (Islamic Republic of) 1866958891 +98 21 3340 1220 farahnaz_moradzadeh66@yahoo.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Patients with schizophrenia in the acute phase Age range 18 to 65 years Receiving only one Antipsychotic drug (Risperidone) IQ greater than 70 Having the consent of the patient and his / her guardian to participate in the research 18 years 65 years Both Having a debilitating physical illness patients with depression Received an electric shock in the last two weeks History of gastric ulcer or acute gastric bleeding Pregnancy and lactation No extra pyramidal symptoms in the study entry based on Simpson-Angus scale Drug, alcohol or drug abuse in the last 6 months (excluding nicotine) There is another diagnosis based on DSM5, including mood disorders and mental retardation Blindness and deafness F20 Schizophrenia Treatment - Drugs Treatment - Drugs Intervention group: Patients with schizophrenia in the acute phase treated with 6 mg of risperidone manufactured by Abidi Company, which will receive 400 mg of celecoxib (200 mg twice daily) produced in Razak Laboratory for 8 weeks. Control group: Patients with schizophrenia treated with risperidone made by Abidi Company who will receive a placebo similar to celecoxib from Razak Laboratory with magnesium stearate content (capsules, daily dose) for 8 weeks. Positive symptoms of schizophrenia. Timepoint: Every 2 weeks to 8 weeks. Method of measurement: Positive And Negative Syndrome Scale. Negative symptoms of schizophrenia. Timepoint: Every 2 weeks to 8 weeks. Method of measurement: Positive And Negative Syndrome Scale. Cognitive symptoms of schizophrenia. Timepoint: Every 2 weeks to 8 weeks. Method of measurement: Montreal Cognitive Assessment Scale. Side effects of medications. Timepoint: Every 2 weeks to 8 weeks. Method of measurement: questionnaire. University of social welfare and rehabilitation sciences Approved 2021-08-30 Ethics Committee of the University of Rehabilitation Sciences and Social Health Tehran University of Rehabilitation Sciences and Social Health, Evin, Daneshjoo Blvd., Koodkiar dead end Tehran Tehran Iran (Islamic Republic of)