Naturalistic Study of Ketamine in the Treatment of Depression (NCT05249309) | Clinical Trial Compass
UnknownNot Applicable
Naturalistic Study of Ketamine in the Treatment of Depression
Brazil90 participantsStarted 2021-05-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ketam…
What they're measuring
1
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Ideation Severity
Timeframe: For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24
2
Changes in Columbia Suicide Severity Rating Scale (C-SSRS) - Behavior
Timeframe: For Weeks 1, 2, 3, 4, 8, 12, 16, 20 and 24