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A Pilot Study on Effect of add-on Sulforaphane to SSRIs and Application of Niacin Skin Flush Response Test in Major Depressive Disorder

Primary Purpose

Major Depressive Disorder

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
SSRIs
SSRI plus Sulforaphane
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Sulforaphane, Niacin skin flush response, Marker, Add-on

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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. having sufficient audio-visual ability and comprehension;
  6. 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.

Sites / Locations

  • Shanghai Mental Health CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

SSRI group

SSRI plus Sulforaphane group

Healthy control group

Arm Description

One SSRI is prescribed based on treatment guidelines for major depressive disorder and drug prescription manual. The dose is 20-60mg/day for fluoxetine, 20-40mg/day for paroxetine, 100-300mg/day for fluvoxamine, 50-200mg/day for sertraline, 20-40mg/day for citalopram, 10-20mg/day for escitalopram, respectively.

One SSRI is prescribed based on treatment guidelines for major depressive disorder and drug prescription manual. The dose is 20-60mg/day for fluoxetine, 20-40mg/day for paroxetine, 100-300mg/day for fluvoxamine, 50-200mg/day for sertraline, 20-40mg/day for citalopram, 10-20mg/day for escitalopram, respectively. 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.

No intervention is given.

Outcomes

Primary Outcome Measures

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 Outcome Measures

changes in levels of serum markers from baseline to the end of the study
changes in levels of serum markers including nuclear factor erythroid-2-related factor 2(Nrf-2), p-Nrf2, Heme Oxygenase-1 (HO-1), malondialdehyde (MDA) and erythrocyte glutathion peroxidase (GPX) from baseline to week 8-12 after treatment
changes in niacin skin flush response test from baseline to the end of the study
changes in signals of blood flow (typified by maximum blood flow, MBF) detected by the Doppler Laser Flowmetry during the niacin skin flush response test from baseline to week 8-12 after treatment

Full Information

First Posted
December 2, 2021
Last Updated
December 6, 2021
Sponsor
Shanghai Mental Health Center
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1. Study Identification

Unique Protocol Identification Number
NCT05148169
Brief Title
A Pilot Study on Effect of add-on Sulforaphane to SSRIs and Application of Niacin Skin Flush Response Test in Major Depressive Disorder
Official Title
A Pilot Study on Effect of add-on Sulforaphane to SSRIs and Application of Niacin Skin Flush Response Test in Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A 12-week, randomized controlled trial (RCT) will be conducted to explore the effect of add-on sulforaphane (SFN) to selective serotonin reuptake inhibitors (SSRIs) for major depressive disorder (MDD). This study also aims to explore the value of niacin skin flush response test in MDD. One hundred adults diagnosed with MDD will be recruited. Then all the patients will be randomly assigned to SSRI only group and SSRI plus SFN group. Clinical symptoms and side-effects will be evaluated using the 17-Hamilton Depression Rating Scale (17-HDRS), the Hamilton Anxiety Scale (HAMA), Treatment Emergent Symptom Scale (TESS), and Asberg's Rating Scale for Side Effects (SERS) at baseline and weeks 2, 4, 8 and 12 after treatment. Fifty healthy subjects will be recruited as control group. For all subjects, testing of niacin skin flush response and serum levels of nuclear factor erythroid-2-related factor 2(Nrf-2), p-Nrf2, Heme Oxygenase-1 (HO-1), malondialdehyde (MDA) and erythrocyte glutathion peroxidase (GPX) will be performed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, Sulforaphane, Niacin skin flush response, Marker, Add-on

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SSRI group
Arm Type
Active Comparator
Arm Description
One SSRI is prescribed based on treatment guidelines for major depressive disorder and drug prescription manual. The dose is 20-60mg/day for fluoxetine, 20-40mg/day for paroxetine, 100-300mg/day for fluvoxamine, 50-200mg/day for sertraline, 20-40mg/day for citalopram, 10-20mg/day for escitalopram, respectively.
Arm Title
SSRI plus Sulforaphane group
Arm Type
Experimental
Arm Description
One SSRI is prescribed based on treatment guidelines for major depressive disorder and drug prescription manual. The dose is 20-60mg/day for fluoxetine, 20-40mg/day for paroxetine, 100-300mg/day for fluvoxamine, 50-200mg/day for sertraline, 20-40mg/day for citalopram, 10-20mg/day for escitalopram, respectively. 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.
Arm Title
Healthy control group
Arm Type
No Intervention
Arm Description
No intervention is given.
Intervention Type
Drug
Intervention Name(s)
SSRIs
Intervention Description
One SSRI(No-specified) is prescribed based on treatment guidelines for major depressive disorder and drug prescription manual. The dose is 20-60mg/day for fluoxetine, 20-40mg/day for paroxetine, 100-300mg/day for fluvoxamine, 50-200mg/day for sertraline, 20-40mg/day for citalopram, 10-20mg/day for escitalopram, respectively.
Intervention Type
Dietary Supplement
Intervention Name(s)
SSRI plus Sulforaphane
Intervention Description
One SSRI(No-specified) is prescribed based on treatment guidelines for major depressive disorder and drug prescription manual. The dose is 20-60mg/day for fluoxetine, 20-40mg/day for paroxetine, 100-300mg/day for fluvoxamine, 50-200mg/day for sertraline, 20-40mg/day for citalopram, 10-20mg/day for escitalopram, respectively. The oral dose of SFN (ZHIYINGUOSU, Shenzhen Fushan Biotech Co. Ltd.) 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.
Primary Outcome Measure Information:
Title
the reduction rate in 17-HDRS total score from baseline to the end of the study
Description
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.
Time Frame
at baseline, week 2/4/8/12 after treatment
Secondary Outcome Measure Information:
Title
changes in levels of serum markers from baseline to the end of the study
Description
changes in levels of serum markers including nuclear factor erythroid-2-related factor 2(Nrf-2), p-Nrf2, Heme Oxygenase-1 (HO-1), malondialdehyde (MDA) and erythrocyte glutathion peroxidase (GPX) from baseline to week 8-12 after treatment
Time Frame
at baseline, week 8-12 after treatment
Title
changes in niacin skin flush response test from baseline to the end of the study
Description
changes in signals of blood flow (typified by maximum blood flow, MBF) detected by the Doppler Laser Flowmetry during the niacin skin flush response test from baseline to week 8-12 after treatment
Time Frame
at baseline, week 8-12 after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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; having sufficient audio-visual ability and comprehension; signed informed consent statements. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaohua Liu, Dr.
Phone
8613918061085
Email
drliuxiaohua@gmail.com
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yifeng Shen, Ph.D
Phone
8621-34773657
Email
shenyifeng@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

A Pilot Study on Effect of add-on Sulforaphane to SSRIs and Application of Niacin Skin Flush Response Test in Major Depressive Disorder

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