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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sulforaphane | Active Comparator | sulforaphane treatment arm |
|
| placebo | Placebo Comparator | placebo arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sulforaphane | Drug | To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Renrong Wu, M.D. Ph.D | Contact | +8615874179855 | wurenrong@csu.edu.cn | |
| Jing Huang, M.D. | Contact | jinghuangserena001@csu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mental Health Institute of Second Xiangya Hospital,CSU | Recruiting | Changsha | Hunan | 410011 | China |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003863 | Depression |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C016766 | sulforaphane |
| D017367 | Selective Serotonin Reuptake Inhibitors |
| ID | Term |
|---|---|
| D014179 | Neurotransmitter Uptake Inhibitors |
| D049990 | Membrane Transport Modulators |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
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Patients will be treated with sulforaphane or placebo for 12 weeks after ramdomization.
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Participants and researchers are blind to treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.
| placedo | Other | To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment |
|
| selective 5 - HT reuptake inhibitors (SSRI) | Drug | To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment |
|
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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020164 | Chemical Actions and Uses |
| D018377 | Neurotransmitter Agents |
| D018490 | Serotonin Agents |
| D045505 | Physiological Effects of Drugs |