Effects of subcutaneous ketamine on depressio

• Conditions: Depressive Disorder, Treatment-Resistant; F03.600.300

• Registration Number: RBR-1072m6nv
• Lead Sponsor: Hospital Universitário Onofre Lopes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-17
• Study Completion: 2022-02-28
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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