Tokyo, June 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059848) titled 'Maintenance of antidepressant effect by magnetic modulation (rTMS) among patients with treatment-resistant depression who responded to low dose ketamine infusion: a double-blind randomized sham rTMS-controlled study' on June 1.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Su Kunbo Medical Research Foundation
Condition:
Condition - Treatment-resistant depression (TRD)
Classification by malignancy - Others
Genomic information - YES
Objective:
Narrative objectives1 - If the efficacy of ketamine infusion + rTMS is greater than ketamine + srTMS, it will approve prolongation/enhancement of ketamine efficacy by physical electronic stimulation and will provide a novel treatment strategy for patients with TRD in the future.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Ketamine 0.5mg+rTMS
Interventions/Control_2 - Ketamine 0.5mg+sham rTMS
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Major depressive episode including unipolar and bipolar depression, according to
DSM-5 criteria and MINI (Mini International Neuropsychiatric Interview;MINI)
diagnostic interview
Key exclusion criteria - 1)Major medical conditions e.g.:head injury, epilepsy, severe renal diseases and cancer.
2)Other axis I psychiatric disorders such as schizophrenia, delusional disorder, organic brain syndrome, and dementia.
3)Pregnancy and Breastfeeding women
4)Substance abuse in previous 6 months such as cocaine, marijuana, opium, ketamine, PCP phencyclidine.
5)Current use of NMDA receptor antagonist Amantadine, Rimantadine, Lamotrigine,Memantine, Dextromethorphan
6)Alcohol abuse and dependence within 6 months.
7)Allergy to Ketamine and Rapamycin.
8)Implanted cardiac pacemaker within 30 cm or metal material like vessel clip in the brain.
9)Those are unable to express willingness to participate.
Target Size - 80
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2024 Year 03 Month 01 Day
Date of IRB - 2024 Year 03 Month 01 Day
Anticipated trial start date - 2024 Year 03 Month 01 Day
Last follow-up date - 2025 Year 11 Month 21 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068437
Disclaimer: Curated by HT Syndication.
