Ketamine administration for treatment-resistant depressio

Not Applicable

Recruiting

• Conditions: Treatment-resistant depression; depression; D061218

• Registration Number: JPRN-jRCTs031210124
• Lead Sponsor: chida Hiroyuki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1.Outpatients or inpatients who meet the criteria for depression according to Structured Clinical Interview for DSM-5 Disorders SCID-5-RV (Research Version) Japanese Version
2. Men and women between the ages of 20 and 60 at the time of registration.
3. Inadequate response to 2 or more antidepressants at approved doses for 6 weeks or more for the current depressive episode
4. A Montgomery-Asberg Depression Rating Scale (MADRS) total score of 22 or higher at the time of screening
5. Being capable of providing informed consent confirmed with scores above 70% in the following four items: understanding, appreciation, reasoning, and the ability to express a choice in the MacArthur Competence Assessment Tool (MacCAT)
6.Written consent being provided by study participant

Exclusion Criteria

1. Having previously received esketamine or ketamine for the treatment of depression
2. Depression with psychotic features according to the diagnostic criteria of the DSM-5
3. Being pregnant, breastfeeding, or hoping to become pregnant
4. A history of epilepsy or seizures
5. A history of cerebrovascular disease
6. A history of ketamine hypersensitivity
7. High blood pressure (systolic pressure 160 mmHg or more, diastolic pressure 100 mmHg or more)
8. A history of cerebral hypertension
9. A history of severe cardiac compensatory failure
10. A history of glaucoma or ocular trauma
11. Receiving electroconvulsive therapy within 3 months prior to enrollment
12. Substance-related disorders (excluding nicotine and caffeine) within 6 months
13. Positive urine screening for dependent substances (except for those who are positive for drugs taken for treatment)
14. having a metallic substance in the body or having a pacemaker
15. the size of the head, neck and body are not suitable for MRI scanners
16. Having tattoos that are larger than one point (including tattoos and art make-up)
17. A high degree of claustrophobia
18. Significant deformity of brain structure (including congenital and traumatic)
19. At the time of registration, any of the following abnormal laboratory values
Serum creatinine 1.5 mg/dl or more
AST 150 IU/L or more
ALT 150 IU/L or more
20. Participated in another clinical trial within 12 weeks prior to enrollment (limited to those with invasion/intervention)
21. Those deemed unsuitable as research subjects by the principal investigator, etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified