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NCT05148169
A Pilot Study on Effect of add-on Sulforaphane to SSRIs and Application of Niacin Skin Flush Response Test in Major Depressive Disorder
Phase 4 trial testing SSRIs in Major Depressive Disorder in 150 participants. Status unknown.
31 December 2022
Quick facts
| Lead sponsor | Shanghai Mental Health Center |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 1 January 2020 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- SSRIs — full drug profile →
- SSRI plus Sulforaphane
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
Sponsor
Shanghai Mental Health Center — full company profile →
Who can join
Adults 18 to 60, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Targeting NLRP3 Inflammasome With Nrf2 Inducers in Central Nervous System Disorders.
Tastan B, Arioz BI, Genc S. · · 2022 · cited 56× · PMID 35418995 · DOI 10.3389/fimmu.2022.865772
Verify or expand the search:
- PubMed search for NCT05148169
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Shanghai Mental Health Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05148169 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Mental Health Center
- Last refreshed: 8 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05148169.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing