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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05148169
• Other study ID #: 201940109
• Status: Recruiting
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: Shanghai Mental Health Center
• Contact: Xiaohua Liu, Dr.
• Phone: 8613918061085
• Email: drliuxiaohua[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Flushing
• Major Depressive Disorder

Intervention

Drug:
• SSRIs
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.

Dietary Supplement:
• SSRI plus Sulforaphane
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.

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at baseline, week 2/4/8/12 after treatment
Secondary	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	at baseline, week 8-12 after treatment
Secondary	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	at baseline, week 8-12 after treatment