Study of the therapy using ketamine in refractory depression

JRCT ID: jRCTs051210192

Registered date:11/03/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: refractory depressive disorder
• Date of first enrollment: 11/03/2022
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Oral administration of placebo, aripiprazole 3mg/12mg or brexpiprazole 2mg, 4 hours prior to ketamine intravenous injection over 40min at 0.5mg/kg.

Outcome(s)

• Primary Outcome: CADSS

Secondary Outcome

Efficacy:BPRS-P, MADRS, PHQ-9, CGI-I, CGI-S, VAS, MOAA/S, anhedonia (MADRS anhedonia factor, PHQ9 anhedonia factor), correlation between scores before treatments and effects of treatments, correlation analysis between each endpoint and plasma drug concentration
Safety: vital signs, Electrocardiogram, Clinical test, Adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Men or women over 18 years (inclusive).
2) Having provided voluntary written consent for participation in this study. If younger than 20 years, Legal representative also has to aggree with the consent.
3) Meet Diagnostic and Statistical Manual of Mental Disorders-5th Edition (DSM-5) diagnostic criteria for major depressive disorder (MDD), based upon the Mini-International Neuropsychiatric Interview, M.I.N.I. The length of the current depressive episode must be longer than or equal to (>=)4 weeks.
4) The MADRS score is higher than or equal to 17, and BDI-II score is higher than or equal to 14.
5) Have had an inadequate response to at least 1 antidepressant, administered at an adequate dose and duration in the current episode of depression, or intolerant to more than one antidepressant.

Exclude criteria

1) Patient has complications such as serious hepatic disorder, renal disorder, heart disease,
lung disease, hematological disease, and metabolic disease.
2) Non-responder to esketamine or ketamine in the depressive episode.
3) Patient has had complications such as neurodevelopmental disorders, schizophrenic disorders, PTSD, Disruptive, impulse-control, and conduct disorders.
4) Patient has complictions such as obsessive-complusivity disorders, anorexia nervosa, bulimia nervosa,
binge eating disorder, neurocognitive disorders, disruptive mood dysregulation disorder.
5) Patient has complication such as epilepsy (including medical history), sleep apnea syndrome, COPD.
6) Patient experienced gastric bypass surgery, gastric sleeve or lap band surgery, or treatment inhibiting gastrointestinal transit.
7) Corrected QT interval >450 msec on an electrocardiogram.
8) Patient with hypertension, systolic and diastolic blood pressures are >140mmHg and >90mmHg, respectively. For patients older than or equal to 65 years, systolic blood pressure is >150mmHg.
9) Significant observation in the Interview, clinical test or 12-lead electrocardiogram.
10) Patient with sucidal tendency and ideation judged with C-SSRS (yes in Q4, Q5 or questions about actual sucidal behaviors except for the item about non-intentional self-injuring behavior)
11) Patient violating the rules of adjunctive medications.
12) Patient has medical history of substance use disorders.
13) Positive in a urine drug screen (except for the case positive because of antidepressant therapy)
14) Pregnant or attempting to be pregnant during the study, and lactating.
15) Difficult to complete the study, having the potential to have disadvantages, difficult to ensure the safety, inappropriate to evaluate the safety and efficacy of the medicines used in this study, or inappropriate judged by principal investigator or subinvestigators.
16)Patients with a history of seizures or hypersensitivity to the components of KETALAR, and patients with cerebrovascular disorders, intracranial hypertension and severe cardiac decompensation.

Related Information

• Primary Sponsor: Murai Toshiya
• Source(s) of Monetary Support: SHIONOGI & CO., LTD.