NCT05249309

Naturalistic Study of Ketamine in the Treatment of Depression

Naturalistic Study of Ketamine in the Treatment of Depression: Suicide Risk Assessment and Serum Measurements of SIRT3, suPAR, hsCRP, Interleukin 6, Complete Blood Count, Leptin, Lipid Profile and Blood Glucose

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study aims to examine the effect of ketamine in decreasing the risk of suicide in patients with depression and its effectiveness as an antidepressant agent.

Detailed description

Mood disorders are chronic, recurrent, and highly prevalent health conditions worldwide. Major depression and bipolar disorder are often associated with psychosocial functional impairments and general medical conditions. Furthermore, suicide figures as one of the most important negative outcomes of mood disorders. In this sense, according to the World Health Organization (WHO), psychiatric disorders are associated with more than 90% of cases of complete suicide and are responsible for 30% of reported suicide cases worldwide. Suicide is a matter of concern for clinicians, not only because of the individual and familiar impact but also due to its social and population impact; then, research involving new potential treatments for suicide behavior ate highly needed. The literature has shown that ketamine, a substance commonly used as an anesthetic, is effective in treating depressive symptoms. Considering the high rate of suicide among patients with mood disorders and its consequences, the aim of this naturalistic study is to investigate the effect of ketamine in reducing the risk of suicide in patients with a depressive episode. The hypothesis is that treatment with ketamine will result in an improvement in depressive symptoms as well as in a decrease in the risk of suicide. Therefore, forty-five patients will be recruited, with major depressive disorder, bipolar I disorder or bipolar II disorder and who were already on ketamine treatment prescribed by assistant psychiatrist (inclusion criteria). Patients will go on the standard protocol of ketamine 0.5mg/kg subcutaneously (SC) twice a week for one month in general. In line with a naturalistic approach, all changes in the protocol, in time and doses will be accepted, according to the assistant doctor prescription without study intervention. After this period, they could receive the same dose of the medication once a week for the third month. In addition, patients will be monitored by phone until month six. Forty-five participants without any personal or first-degree family history of psychiatry or neurologic disorders will be recruited to participate as controls. Biochemical analyses will be used to investigate inflammatory markers, transcription factors and other peripheral biomarkers in patients with mood disorders and healthy controls.

Conditions

• Major Depressive Disorder
• Bipolar Disorder
• Bipolar Depression
• Bipolar I Disorder
• Bipolar II Disorder
• Affective Disorder

Interventions

Type	Name	Description
DRUG	Ketamine	The administration will be done subcutaneously, in the abdominal wall, using ketamine without dilution. The ketamine dose will be 0.5mg/kg, recommended for the first infusion. If there is no adequate response, according to psychiatric scales and clinical evaluation, the second infusion must be performed at least two days after the first, using 0.75mg/kg and the subsequent 1mg/kg. If the patient adequately responds to a dose (0.5 or 0.75mg/kg), it should be repeated after over twice weekly over a period of 4 weeks.

Timeline

• Start date: 2021-05-01
• Primary completion: 2022-11-01
• Completion: 2023-12-15
• First posted: 2022-02-21
• Last updated: 2023-09-25

Locations

2 sites across 1 country: Brazil