The effect of single dose of ketamine injection in reducing suicidal ideation in type 1 bipolardisorder patients in the depressive phase

The effect of single dose of ketamine injection in reducing suicidal ideation in type 1 bipolardisorder patients in the depressive phase

The study will be double blind and clinical trial.124 patients will be randomly divided into 2 groups. The groups are parallel. The trial phase is 3.

Patients With type 1 bipolardisorder patients in the depressive phase in Amirkabir Hospital in Arak are divided into 4 groups by simple randomization with blocks.The study is double-blind in which outcome evaluator and data analyst and participant are kept blind.

Conditions for entering the study: patients with bipolar disorder type 1 in the depressive phase according to DSM5 criteria and having suicidal thoughts, not using drugs in the last one month, not receiving electric shocks in the last month and during the last hospitalization, 15 to 65 years old absence of mental retardation, absence of underlying disease, absence of history of stroke, seizures, brain tumor, dementia and being in the delirium phase, absence of history of head injury and loss of consciousness, absence of any drug and alcohol use in the past month Conditions for withdrawal from the study: lack of consent of the patient or the guardian to participate in the study, allergy to the drug

In one group, intravenous ketamine (0.5 mg per kilogram of intravenous ketamine over 30 minutes) will be used, and in the other group, normal saline (500 ml of normal intravenous saline) will be used as a placebo. And the Beck questionnaire is evaluated before injection, 2 hours after injection, 24 hours after and 72 hours after injection.

Suicidal ideation score

Patients will be allocated into2 groups using a permuted balanced block randomization method with the size of blocks 4. Random sequence will be generated by an epidemiologist by running an online program in sealed envelope website (https://www.sealedenvelope.com/). Random chain concealment is done by opaque envelope method.

This study will be double-blind, considering that both groups receive the drug in the form of serum and the form of injection in both groups is the same, the patients will not know what treatment they are receiving. Also, on this basis, in order to divide the patients, an envelope was used, which was determined based on the letters A (intervention group) and B (placebo group), and based on this, the patient and the doctor were blinded to the patient group. After obtaining the consent of the guardian, the patient enters the study and the medicine is prepared by the anesthesiologist and given to the anesthesiologist and the injection is done under the supervision of the anesthesiologist and psychiatry resident. Based on this, the patients and the psychiatric assistant and the anesthesia technician are blind to the type of drug and the group of patients, but the anesthesiologist who prepares the drugs and provides them to the assistant and the technician for injection is unaware of the type of drugs.