Status:
UNKNOWN
Naturalistic Study of Ketamine in the Treatment of Depression
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Federal University of Rio Grande do Sul
Hospital Moinhos de Vento
Conditions:
Major Depressive Disorder
Bipolar Disorder
Eligibility:
All Genders
18+ years
Brief 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 15 2023
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05249309
Start Date
May 1 2021
End Date
December 15 2023
Last Update
September 25 2023
Active Locations (2)
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1
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90035-000
2
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903