NCT05148169

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4 major-depressive-disorder

Timeline
Completed

Started Jan 2020

Typical duration for phase_4 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 8, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

December 8, 2021

Status Verified

November 1, 2021

Enrollment Period

3 years

First QC Date

December 2, 2021

Last Update Submit

December 6, 2021

Conditions

Major Depressive Disorder

Keywords

Major Depressive DisorderSulforaphaneNiacin skin flush responseMarkerAdd-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.

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

Secondary Outcomes (2)

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

    at baseline, week 8-12 after treatment

  • changes in niacin skin flush response test from baseline to the end of the study

    at baseline, week 8-12 after treatment

Study Arms (3)

SSRI group

ACTIVE COMPARATOR

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.

Drug: SSRIs

SSRI plus Sulforaphane group

EXPERIMENTAL

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.

Drug: SSRIsDietary Supplement: SSRI plus Sulforaphane

Healthy control group

NO INTERVENTION

No intervention is given.

Interventions

SSRIsDRUG

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.

SSRI groupSSRI plus Sulforaphane group
SSRI plus SulforaphaneDIETARY_SUPPLEMENT

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.

SSRI plus Sulforaphane group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, 200030, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Selective Serotonin Reuptake Inhibitorssulforaphane

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNeurotransmitter AgentsSerotonin AgentsPhysiological Effects of Drugs

Central Study Contacts

Xiaohua Liu, Dr.

CONTACT

8613918061085drliuxiaohua@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

Study Record Dates

First Submitted

December 2, 2021

First Posted

December 8, 2021

Study Start

January 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

December 8, 2021

Record last verified: 2021-11

Locations

CN(1)