The effect of single dose injection of ketamine in comparison with midazolam on acute suicidal thoughts in psychiatric patients: a double-blind clinical trial

The effect of ketamine in reducing suicidal ideation in short-term psychiatric patients

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 36 patients. Sampling was performed by available sampling. Using G * POWER 3.1.9.2 software and assuming effect size = 0.4, alpha 0.05 and beta 0.2, three measurements and a correlation of 0.5 between measurements, the sample size was 18 in each group.

Study place: Rasoul Akram and Iran Hospital. The study population: clients of two above centers with acute suicidal ideation who were satisfied to participate in the study. Blinding: after admission, in collaboration with the treating physician and the supervisor, patients will receive medication or placebo based on a table of random numbers that the evaluator and analyst are unaware of the type of medication.

Inclusion criteria: Clients with acute suicidal ideation; Age range of 18-68 years old. Non-inclusion criteria: physical disorders such as thyroid dysfunction, diabetes, hypertension, stroke and brain surgery and other neurological disorders; pregnant and lactating women; convulsion; recurrent and regular antidepressant drug use; psychosis

Intervention group: Neurotic patients with suicidal ideation with single dose of ketamine injection, who will be interviewed by a psychiatrist, performed Hamilton test, VAS and BSSI. Control group: Patients with suicidal ideation receiving single dose of midazolam and similar evaluations of the intervention group

Score of Beck scale suicidal ideation; score of Visual analog scale

Ketamine and midazolam are coded as A and B. A random sequence of A and B is created using a table of random numbers which is maintained by one of the researchers. The researcher prescribing the drug is not aware of the group to which the next patient is allocated until the moment of prescribing the drug. The intervention category of each patient is specified as A or B upon administration by contacting the researcher who has access to the sequence. Midazolam and ketamine are prepared in identical appearance, are labeled as A and B, and retained for the sole purpose of this research

participants and evaluators and analysts are not aware of the injection of the midazolam or Ketamine . The supervisor and the attending physician are aware of the injected drug. After randomization and receiving the code, the physician will be informed through the supervisor who is aware of the received code. The evaluator and analyst will only know about group A or B.Ketamine and midazolam are both injectable and colorless and are prepared in normal saline and midazolam is injected at a low dose to reduce the sedative effect of it, which causes the study to go out of the double-blind state.

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Access period from 2021

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Maryam Barzkar

Sending email to maryam.barzkar@gmail.com