Naturalistic Study of Ketamine in the Treatment of Depression

This observational study (n=90), conducted by Hospital de Clinicas de Porto Alegre, Brazil, aims to assess the impact of ketamine on reducing the risk of suicide in patients with depression, along with its effectiveness as an antidepressant.

Forty-five patients diagnosed with major depressive disorder, bipolar I disorder, or bipolar II disorder, who are already undergoing ketamine treatment as prescribed by an assistant psychiatrist, will be included. These patients will follow the standard ketamine protocol of 0.5mg/kg subcutaneously twice a week for one month, with possible adjustments according to the physician’s prescription. After the initial month, patients may receive the same dose once a week for the third month, followed by phone monitoring until month six.

Additionally, forty-five control participants without psychiatric or neurological disorders will be recruited. The study will measure changes in suicidal ideation and behaviour using the Columbia Suicide Severity Rating Scale (C-SSRS) and assess depressive symptoms, psychotic symptoms, functioning, and various blood biomarkers. The observational model will span over six months, with biospecimens retained for DNA analysis. The study’s primary completion is estimated for November 2022, with an enrollment goal of 90 participants.

Topic Depression Suicidality Bipolar Disorder
Compound Ketamine
Country Brazil
Visit trial
Status Active, not recruiting
Results Published No
Start date 01 May 2021
End date 15 December 2023
Phase Not Applicable
Design Open
Type Observational
Generation First
Participants 90
Sex All
Age 18- 99
Therapy No

Trial Details

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.

NCT Number NCT05249309

Sponsors & Collaborators

Hospital de Clinicas de Porto Alegre
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Data attribution

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