A 12-weeks Study to Evaluate Sulforaphane in the Treatment of Depression

Phase 2

• Conditions: Depressive Disorder
• Interventions: Other: placedo; Drug: sulforaphane; Drug: selective 5 - HT reuptake inhibitors (SSRI)

• Registration Number: NCT04246905
• Lead Sponsor: Central South University

Brief Summary

Major depressive disorder is a serious, recurrent and disabling mental disorder, which is the second leading cause of years lost to disability worldwide. Accumulating evidence suggests the important role for inflammation and oxidative stress in the pathophysiology of depression. Sulforaphane extracted from broccoli sprout is an agent with potent anti-oxidant and anti-inflammatory activity. Previous studies suggested sulforaphane activates Keap1-Nrf2 system to prevent depression-like phenotype in mice. In this study, the investigator attempts to evaluate the efficacy, safety, and tolerability of sulforaphane plus a fixed oral antipressant in adult participants diagnosed with depression.

Detailed Description

A total of 90 patients aged 18-55 years with depression will be included, all of whom gave informed consent. Participants will receive 12 weeks of either sulforaphane or placebo per day, in addition to the existing treatment. Baseline assessments include demographics, a comprehensive medical history, anthropometric measurements (weight and height), physical examination, and lab work. Clinical symptoms will be assessed by the Montgomery-A° sberg Depression Rating Scale (MADRS), Hamilton depressive scale (HAMD), Hamilton Anxiety Scale(HAMA), and Patient Health Questionnaire-9 (PHQ-9). The safety will be assessed by Treatment Emergent Symptom Scale (TESS). The cognitive function will be evaluated by MATRICS Consensus Cognitive Battery （MCCB）at the beginning of the study and at week 12. The cranial MRI is examined at baseline and repeated at week 12. The primary outcomes will be the effective time and the percentages of efficacy at 8 weeks, measured using the MADRS. Efficacy is defined as ≥50% decreases in the total score of MADRS. Secondary outcomes include global psychopathology, quality of life, functioning, cognition, biological data, safety and tolerability.

Study Timeline

• Study First Submitted: 2020-01-06
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-29
• Study Start: 2020-07-15
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-18
• Last Update Posted: 2020-08-20
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 18-55 years old
• Clinical diagnosis of recurrent MDD or single-episode MDD with MADRS≥22, CGI-SI≥4
• be adherent to the continued oral antidepressant treatment medication

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Exclusion Criteria

• treatment-resistant depression
• have known allergies, hypersensitivity, intolerance, or contraindications to SSRI or any of the trial preparations
• strong homicidal ideation/intent
• pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sulforaphane	selective 5 - HT reuptake inhibitors (SSRI)	sulforaphane treatment arm
placebo	selective 5 - HT reuptake inhibitors (SSRI)	placebo arm
placebo	placedo	placebo arm
sulforaphane	sulforaphane	sulforaphane treatment arm

Primary Outcome Measures

Name	Time	Method
Change from baseline Montgomery-A° sberg Depression Rating Scale (MADRS) total score at week 8	baseline and week 8	Range from 0-60, higher score indicates more severe symptoms

Secondary Outcome Measures

Name	Time	Method
Changes of Hamilton depressive scale (HAMD) from baseline to week 12	Week 0 and week 12.	Range from 24-75, higher score indicates more severe symptoms
the total scores of Hamilton depressive scale (HAMD)	Week 0, 2, 4, 6, 8, 12.	Range from 24-75, higher score indicates more severe symptoms
Hamilton Anxiety Scale(HAMA)	Week 0, 2, 4, 6, 8, 12.	Range from 0-56, higher score indicates more severe symptoms
The total score of clinical global impression-severty of illness (CGI-SI)	Week 0, 2, 4, 6, 8, 12.	Range from 0-7, higher score indicates more severe symptoms
Change of MATRICS Consensus Cognitive Battery （MCCB）from baseline to week 12	Week 0, 12.	To evaluate the efficacy of adjunctive sulforaphane treatment in improving cognitive functions. Higher score indicates better cognition

Trial Locations

Locations (1)

Mental Health Institute of Second Xiangya Hospital,CSU; 🇨🇳 Changsha, Hunan, China