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

The effect of adding celecoxib to risperidone to reduce positive, negative and cognitive symptoms in patients with acute phase schizophrenia

Clinical trial with control group, with parallel, double-blind, randomized, phase 3 groups on 52 patients who were randomly divided into two groups of intervention and control, 26 people. In order to randomly assign people to two groups, a random sequence of numbers is created using web-based software.

Razi Psychiatric Hospital Double-blind study (patients, researchers, psychiatrists and psychologists, patient caregivers, data collector, data analyst) In addition to treatment with 6 mg risperidone, the intervention group received celecoxib at a dose of 400 mg orally daily (200 mg BD) for 8 weeks, and the control group received a treatment regimen consisting of risperidone tablets with the same placebo. Will receive. Positive, negative and cognitive symptoms of patients will be evaluated when entering the study and then every 2 weeks.

Inclusion criteria: Schizophrenic patients in the active phase, Male and female patients ranging in age from 18 to 65 years, Take only one type of antipsychotic drug (risperidone), IQ greater than 70, Having the consent of the patient and his / her guardian to participate in the research Exclusion criteria: Having any debilitating physical illness, Depression based on the Hamilton test, History of gastric ulcer or acute gastric bleeding, Blindness and deafness, Drug, alcohol or drug abuse in the last 6 months (excluding nicotine), Receive ECT in the last two weeks, Breastfeeding and pregnancy

Patients with schizophrenia are treated with risperidone, receiving celecoxib as adjunctive therapy, and the control group receiving risperidone and placebo.

Positive, negative and cognitive symptoms of schizophrenia

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

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.