The Effect of N-Acetyl cysteine on Cognitive performance Impairment During Electro Convulsive Therapy in Patients with Bipolar disorder

Comparison of the improvement score of cognitive function due to Electroconvulsive therapy in patients with bipolar disorder in two groups receiving n-acetyl cycteine and placebo.

Clinical trial with a control group, with parallel groups, Triple-blind , randomized, phase 3 on 52 patients. Block randomization method was used for randomization.

Bipolar patients candidates for electroshock therapy who are hospitalized in Shafa hospital, Rasht will be randomly assigned to intervention and control groups by the random block method. Patients, investigators, and data analyzer will be blinded to the study groups.

Patients older than 18 years of age with bipolar disorder, and at the beginning of treatment with Electroconvulsive therapy. Exclusion criteria: schizophrenia, liver or kidney failure, history of seizures, drug or alcohol use, history of n-acetyl cysteine allergy, Pregnancy, breastfeeding.

Intervention group: 26 Patients in the intervention group will receive one 600 mg oral n-acetyl cycteine effervescent tablet manufactured by Osve Company, every 12 hours, from 24 hours before the start of Electroconvulsive therapy (ECT) to 24 hours after the end of ECT. Usually, patients receive 6 sessions of electroconvulsive therapy, therefore, the duration of drug treatment will be two weeks. Control group: 26 Patients in the control group will receive one placebo manufactured by Osve Company, every 12 hours, from 24 hours before the start of Electroconvulsive therapy (ECT) to 24 hours after the end of ECT. Usually, patients receive 6 sessions of electroconvulsive therapy, therefore, the duration of drug treatment will be two weeks.

Cognitive impairment

Randomization will be performed by blocks of size 4, using sealedenvelope.com website. For allocation concealment, opaque envelopes sealed with a random sequence (snose) will be used.

In this triple-blinded study, the patient, the investigator, and the data analyzer were blinded to the studied groups. Sealed envelopes for randomization, drug and placebo in similar envelopes are provided to the nurse of the department and when the patient enters, the medicine or placebo is given to the patient based on the code written in the envelope.The patient and the researcher do not know about the treatment group, and only the ward nurse and the patient's caregiver know about the grouping.

According to the approval of the ethics committee of Guilan University of Medical Sciences, in order to respect the privacy of patients, there is no plan to publish the results of patients.