Depressive Disorder, Treatment-Resistant
Conditions
Interventions
Experimental group: 40 patients with treatment-resistant depression will receive ketamine (in the form of dextrocetamine) subcutaneously once a week for 8 weeks, using an open design. The first sessio
E02.319
Sponsors
Hospital Universitário Onofre Lopes
Hospital Universitário Onofre Lopes
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients in current severe depressive episode, occurring for at least 4 weeks, and who have already used at least two antidepressant drugs, in an appropriate dose and duration; age between 18 and 45 years old.
Exclusion criteria
Exclusion criteria: uncontrolled hypertension; congestive heart failure or other evidence of impaired cardiac status; COPD; severe obesity; increased intracranial or cerebrospinal pressure; pregnancy; hyperthyroidism; adverse response to ketamine; present or past psychotic symptoms; dissociative identity disorder; autism spectrum disorder; prodromal symptoms of schizophrenia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the average change in the total score of the Montgomery-Asberg depression rating scale between baseline and day 7 (one week) after the first infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate change in the total score of the Montgomery-Asberg depression rating between the baseline and days 1 and 2 after the session;;To evaluate changes in self-applied depression and suicide scales;To evaluate the relationship between the Mystical Experience Questionnaire and the 5 Altered States of Consciousness Rating Scale and changes in symptoms of depression;To evaluate the aberrant salience during the acute effects of ketamine and the relationship between changes in aberrant salience and changes in symptoms of depression;To evaluate the relationship between changes in salivary cortisol levels and biochemical markers and symptoms of depression ;To evaluate changes in sleep and relationship with changes in symptoms of depression;To evaluate changes in rumination processes and the relationship with depression symptoms | — |
Countries
Brazil
Contacts
Public ContactDraulio de Araujo
Outcome results
None listed