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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Adjunctive Sulforaphane for Depression: Study Protocol for a Randomized, Double-blind, Placebo-controlled Study

Conditions
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Depressive Disorder

Intervention / Treatment
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* Drug: sulforaphane
* Other: placedo
* Drug: selective 5 - HT reuptake inhibitors (SSRI)


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be treated with sulforaphane or placebo for 12 weeks after ramdomization.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sulforaphane<br>sulforaphane treatment arm | Drug: sulforaphane<br>* To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment<br>Drug: selective 5 - HT reuptake inhibitors (SSRI)<br>* To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment<br>|
| Placebo Comparator: placebo<br>placebo arm | Other: placedo<br>* To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment<br>Drug: selective 5 - HT reuptake inhibitors (SSRI)<br>* To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sulforaphane, Depression, Fatigue, Cognition