NCT05145270

A Comparative Study on Efficacy and Safety of add-on Sulforaphane or rTMS to Escitalopram for Major Depressive Disorder With Poor Response to Initial Treatment

Status unknown Phase 4 Last updated 6 December 2021

What this trial tests

Phase 4 trial testing Escitalopram+Sulforaphane in Major Depressive Disorder in 180 participants. Status unknown.

Timeline

30 November 2019

Primary endpoint
30 November 2022

30 November 2022

Quick facts

Lead sponsor	Shanghai Mental Health Center
Phase	Phase 4
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	180
Start date	30 November 2019
Primary completion	30 November 2022
Estimated completion	30 November 2022
Sites	1 location across China

Drugs / interventions tested

• Escitalopram+Sulforaphane
• Escitalopram+rTMS
• Escitalopram (escitalopram) — full drug profile →

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

Shanghai Mental Health Center — full company profile →

Who can join

Adults 18 to 60, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A 12-week, randomized controlled trial (RCT) with parallel grouping design will be conducted to compare the efficacy and safety of different treatments. One hundred and eighty adults diagnosed with major depressive disorder (MDD) with no or poor response to initial antidepressant treatment will be recruited. Then all the patients will be 1:2:2 randomly assigned to different intervention groups including escitalopram, escitalopram plus sulforaphane (SFN) , and escitalopram plus repetitive transcranial magnetic stimulation (rTMS). Clinical symptoms and side-effects will be evaluated or recorded using the 17-Hamilton Depression Rating Scale (17-HDRS), the Hamilton Anxiety Scale (HAMA), side-effects sheet, etc., at Critical Decision Points (CDP) including weeks 2, 4, 8 and 12 after treatment. Blood cell counting, biochemical, and electrocardiogram examination will be performed at weeks 4, 8 and 12 after treatment in order to evaluate the effect of different interventions on the physical condition. In addition, niacin skin flush response and serum markers including nuclear factor erythroid-2-related factor 2(Nrf-2), p-Nrf2, malondialdehyde (MDA), superoxide dismutase (SOD) and erythrocyte glutathion peroxidase (GPX) will be tested at baseline and endpoint. The primary outcome is the reduction rate in 17-HDRS total score from baseline to the end of the study. The secondary outcomes include changes in niacin skin flush response test and levels of serum markers. All the data will be analyzed by SPSS software.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting NLRP3 Inflammasome With Nrf2 Inducers in Central Nervous System Disorders.
   Tastan B, Arioz BI, Genc S. · · 2022 · cited 56× · PMID 35418995 · DOI 10.3389/fimmu.2022.865772
2. The Regulatory Effect of Phytochemicals on Chronic Diseases by Targeting Nrf2-ARE Signaling Pathway.
   He WJ, Lv CH, Chen Z, Shi M, et al · · 2023 · cited 46× · PMID 36829795 · DOI 10.3390/antiox12020236
3. Anti-oxidative stress treatment and current clinical trials.
   Zhang CY, Yang M. · · 2024 · cited 3× · PMID 38495278 · DOI 10.4254/wjh.v16.i2.294