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Naturalistic Study of Ketamine in the Treatment of Depression

NCT05249309 · Hospital de Clinicas de Porto Alegre

Closed to entry
Status
Not accepting participants
Not applicable
Phase
90
Target enrolment
2
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity

    Measured over For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24

  • Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior

    Measured over For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Accepted
Healthy volunteers
Inclusion criteria Having a diagnosis according to DSM-5 for * Major depressive episode as part of either Major depressive disorder, Bipolar I disorder, or Bipolar II disorder according to Fifth Edition of Diagnostic and Statistical Manual for Mental Disorders (DSM-5); * 18 years old or older; * Be able to provide written informed consent.episode; * MADRS scale total score ≥ 12 and score in items 1 (apparent sadness) and 2 (expressed sadness) ≥ 2 during the screening period (baseline); * YMRS scale total score ≤ 11 at baseline; * Having current symptoms of suicidal ideation and/or behavior, according to the C-SSRS scores; * Use of effective contraceptive methods in the case of heterosexual women of childbearing age; * Indication/prescription of the attending physician for the use of ketamine, subcutaneous; * For the patients with Bipolar I disorder: currently using lithium, valproic acid, or atypical antipsychotic at therapeutic doses for at least four weeks prior to initial evaluation. * For patients with Bipolar II disorder: currently using lithium, valproic acid, lamotrigine, or atypical antipsychotic at therapeutic doses for at least four weeks prior to initial evaluation. Exclusion Criteria * Patients with an unstable, defined, or suspected systemic medical condition; * Women who are pregnant, breastfeeding or planning to become pregnant within the next year; * Patients who cannot tolerate the use of ketamine or who have previous adverse effects associated with ketamine; * Inability to comply with informed consent or treatment protocol needs; * Patients currently with psychotic symptoms (according to DSM-5 criteria); * Patients with a current diagnosis of any active substance use disorder according to the MINI/DSM-5 criteria (with the exception of tobacco); * Patients with autoimmune or inflammatory conditions, cancer or active infectious diseases.

Where

2 study sites

FacilityCityRegionCountry
Hospital Moinhos de VentoPorto AlegreRio Grande do SulBrazil
Hospital de Clinicas de Porto AlegrePorto AlegreRio Grande do SulBrazil

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05249309 on ClinicalTrials.gov →

Last updated in the registry 2023-09-25. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits