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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

NCT ID: NCT05145270

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depressive Disorder

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Escitalopram

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

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

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

Escitalopram plus Sulforaphane

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.

Group Type EXPERIMENTAL

Escitalopram+Sulforaphane

Intervention Type 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

Intervention Type DRUG

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

Escitalopram plus rTMS

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.

Group Type EXPERIMENTAL

Escitalopram+rTMS

Intervention Type 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

Intervention Type DRUG

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

Interventions

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Escitalopram+Sulforaphane

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 .

Intervention Type DIETARY_SUPPLEMENT

Escitalopram+rTMS

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.

Intervention Type DEVICE

Escitalopram

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. aged 18-60 years;
2. diagnosed with moderate or severe depressive disorder according to the criteria of the DSM-5;
3. total score of 17-HDRS≥17;
4. never receiving electroconvulsive therapy (ECT)/modified ECT (MECT)/rTMS or other treatments in the past month;
5. 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;
6. having sufficient audio-visual ability and comprehension;
7. signed informed consent statements.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Mental Health Center

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaohua Liu, Dr.

Role: CONTACT

Phone: 8613918061085

Email: [email protected]

Facility Contacts

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Yifeng Shen, Ph.D

Role: primary

Other Identifiers

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SHDC12019X09

Identifier Type: -

Identifier Source: org_study_id