1- Determining the effect of celecoxib compared to placebo on inflammatory indices in patients with schizophrenia treated with electroconvulsive therapy
2- Comparison of inflammatory indicators (blood biochemical changes) in two groups
3- Comparison of overall performance (GAF) in two groups
4- Comparison of cognitive changes in two groups
5- Comparison of changes in positive and negative symptoms (PANSS) in two groups
6- Comparison of possible side effects in two groups
Design
A clinical trial with the control group, with parallel groups, single-blind, randomized, without reference on 48 patients.
Settings and conduct
Schizophrenia patients in Quds Hospital treated with electroconvulsive therapy are randomly divided into witness and control groups. The witness group is given a placebo during the period of receiving electric shocks and the control group is given celecoxib. Inflammatory indices in the blood are measured before and after the procedure and finally, the results are compared.
Participants/Inclusion and exclusion criteria
Schizophrenia patients treated with electric shock with 18 to 60 years old without underlying disease, and not addicted to drugs and alcohol.
Intervention groups
Before the start of the shock therapy sessions, after the third session, and at the end of the sessions, blood samples are taken to check the blood cell count and inflammatory markers. For these patients, the Celecoxib drug is started before the start of shock treatment sessions.
Control group: Same as above grout but the direction of these patients starts before the start of the placebo shock therapy sessions.
Main outcome variables
blood biochemical indicators, general performance, cognition, positive and negative symptoms, side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130723014122N2
Registration date:2023-04-24, 1402/02/04
Registration timing:registered_while_recruiting
Last update:2023-04-24, 1402/02/04
Update count:0
Registration date
2023-04-24, 1402/02/04
Registrant information
Name
Azad Maroufi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 1666 0025
Email address
maroufi@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-10-22, 1402/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of celecoxib on symptoms of patients with Schizophrenia under Electroconvulsive Therapy
Public title
Effect of celecoxib on symptoms of patients with Schizophrenia under Electroconvulsive Therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with Schizophrenia under Electroconvulsive Therapy
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
48
More than 1 sample in each individual
Number of samples in each individual:
3
Blood sample for testing, blood cell count and inflammatory markers
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, we used the quadruple random block method. For this purpose, we prepare four sheets of paper for each drug and placebo group separately. We write the letter A (intervention group) on two sheets and the letter C (comparison group) on the other two sheets.We mix the sheets together and put them in the desk drawer. With the referral of each of the eligible patients, one of the sheets was randomly drawn and based on this drawn sheet, A or C was assigned to one of the two intervention groups (celecoxib) and the control group (placebo), respectively.It should be noted that the drawn cards are not returned to the drawer until all four cards are drawn. After randomly pulling out fourteen sheets, all the sheets were returned to the drawer and the above operation was continued for the next four patients until the desired sample size was reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
We use the block method for blinding.
According to the study, there are 2 modes. State A (Celecoxib drug) State B (Placebo)
The order of random placement of these two modes is 6 types.
We write these 6 species and assign a number to each one. For example -/1- -/AABB
To write the table, we randomly pick a number from among the written numbers and write the state of that number in the table. When the table is filled with the number of participants, we proceed according to the table. For the first participant, we choose the first block, which is, for example, A, and for the second participant, we choose the second block, which is, for example, A again, and move on...
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences