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

NCT05145270 | Unknown Phase 4 DMC

• 1 other identifier: SHDC12019X09
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; Sulforaphane; rTMS; Efficacy; Oxidative stress; Marker; Add-on

Outcome Measures

Primary Outcomes (1)

• the reduction rate in 17-HDRS total score from baseline to the end of the study

  Remission is defined as 17-HDRS total score ≤7; Response is defined as ≥50% decrease from 17-HDRS total score at baseline and 17-HDRS total score\>7; Nonresponse is defined as having a reduction of\<50% on the total score of 17-HDRS comparing with baseline.

  at baseline, week 2/4/8/12 after treatment.

Secondary Outcomes (1)

• changes in levels of serum markers from baseline to the end of the study

  at baseline, week 8-12 after treatment.

Study Arms (3)

Escitalopram

ACTIVE COMPARATOR

The dose of Escitalopram based on treatment guidelines for major depressive disorder and drug prescription manual is 10-20mg/day, once per day.

Drug: Escitalopram

Escitalopram plus Sulforaphane

EXPERIMENTAL

The dose of Escitalopram based on treatment guidelines for major depressive disorder and drug prescription manual is 10-20mg/day, once per day. The oral dose of SFN is based on weight. The usage and dosage are as follows: 40-70kg, 4 tablets/day (containing 274μmol of glucosinolates); 70-90kg, 6 tablets/day (containing 411μmol of glucosinolates). Take it once in the morning and evening.

Dietary Supplement: Escitalopram+Sulforaphane; Drug: Escitalopram

Escitalopram plus rTMS

EXPERIMENTAL

The dose of Escitalopram based on treatment guidelines for major depressive disorder and drug prescription manual is 10-20mg/day, once per day. rTMS is delivered to the left dorsolateral prefrontal lobe position. Stimulation parameters are set to be 80 stimulation strings of 10Hz with an interval of 12 seconds. Each stimulation string includes 30 stimulations lasting for 3 seconds. One session includes 2400 stimulation strings lasting for 19 minutes and 40 seconds. The course of rTMS treatment includes 20 sessions, once a day or twice a day.

Device: Escitalopram+rTMS; Drug: Escitalopram

Interventions

Escitalopram+Sulforaphane DIETARY_SUPPLEMENT

Escitalopram(No-specified) 10-20mg/d, once per day; Sulforaphane(ZHIYINGUOSU, Shenzhen Fushan Biotech Co. Ltd.). 40-70kg, 4 tablets/day (containing 274μmol of glucosinolates); 70-90kg, 6 tablets/day .

Escitalopram plus Sulforaphane

Escitalopram+rTMS DEVICE

Escitalopram(No-specified) 10-20mg/d, once per day; rTMS: rTMS is delivered to the left dorsolateral prefrontal lobe position. Stimulation parameters are set to be 80 stimulation strings of 10Hz with an interval of 12 seconds. Each stimulation string includes 30 stimulations lasting for 3 seconds. One session includes 2400 stimulation strings lasting for 19 minutes and 40 seconds. The course of rTMS treatment includes 20 sessions, once a day or twice a day.

Escitalopram plus rTMS

Escitalopram DRUG

Escitalopram(No-specified) 10-20mg/d, once per day.

Escitalopram; Escitalopram plus Sulforaphane; Escitalopram plus rTMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• aged 18-60 years;
• diagnosed with moderate or severe depressive disorder according to the criteria of the DSM-5;
• total score of 17-HDRS≥17;
• never receiving electroconvulsive therapy (ECT)/modified ECT (MECT)/rTMS or other treatments in the past month;
• no response or poor response (having a reduction of \<20% on the total score of the 17-item Hamilton Depression Scale compared with the baseline) to adequate antidepressants (except escitalopram) treatment for at least 4 weeks;
• having sufficient audio-visual ability and comprehension;
• signed informed consent statements.

You may not qualify if:

• serious or active somatic illness (abnormal index values were more than twice the limit of normal);
• a history of mania/hypomania;
• current high risk of suicide (score of item 3 of 17-HDRS ≥ 3);
• pregnant or lactating women, or planning pregnant women;
• taking immunosuppressants or vitamins recently.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, 200030, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Xiaohua Liu, Dr.

CONTACT

8613918061085; drliuxiaohua@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All the participants 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).

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 6, 2021
• Study Start: November 30, 2019
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: December 6, 2021

Record last verified: 2021-09

Locations

CN (1)