Treatment-resistant depression depression
Conditions
Interventions
Ketamine: Twice a week for 2 weeks (4 times in total), intravenous administration of ketamine hydrochloride (0.5 mg/kg) plus saline solution (total amount 50 mL) will be performed over 40 minutes.
Pla
ketamine
Sponsors
Uchida Hiroyuki
Takahashi Takuya
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of mood symptoms assessed with MADRS | — |
Secondary
| Measure | Time frame |
|---|---|
| -Severity of mood symptoms assessed with HDRS -Severity of mood symptoms assessed with QIDS-SR -Severity of obsessive-compulsive symptoms -Severity of obsessive symptoms assessed with Y-BOCS -Cognitive function assessed with RBANS -Degree of suicidal ideation assessed with BSS -Adverse events associated with ketamine administration | — |
Contacts
Public ContactHiroyuki Uchida
Keio University Hospital
Outcome results
None listed