Depressive DisorderPhase 2NCT04246905
A 12-weeks Study to Evaluate Sulforaphane in the Treatment of Depression
A Phase 2 study testing sulforaphane, placedo and selective 5 - HT reuptake inhibitors (SSRI) in people with Depressive Disorder, run by Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- sulforaphane, placedo and selective 5 - HT reuptake inhibitors (SSRI)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2020to 31 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- treatment-resistant depression
- have known allergies, hypersensitivity, intolerance, or contraindications to SSRI or any of the trial preparations
- strong homicidal ideation/intent
- pregnancy
Trial locations and contacts
1 site in 1 country.
Jing Huang, M.D. contact
China1 site, 1 recruiting
- Recruiting
Mental Health Institute of Second Xiangya Hospital,CSU
Changsha, Hunan, 410011
Renrong Wu, PhD, 15874179855, wurenrong2013@163.com
About this study
Official title: Efficacy of Adjunctive Sulforaphane for Depression: Study Protocol for a Randomized, Double-blind, Placebo-controlled Study
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.
Read the 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.
- Conditions
- Depressive Disorder
- Being tested
- sulforaphane, placedo, selective 5 - HT reuptake inhibitors (SSRI)
- Keywords
- Sulforaphane, Depression, Fatigue, Cognition
- Medical subject headings
- Depressive Disorder, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sulforaphaneDrug
To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment
placedoOther
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
| Study group | Role | What they receive |
|---|---|---|
| sulforaphane | Active comparator | sulforaphane treatment arm Receives: Drug: sulforaphane; Drug: selective 5 - HT reuptake inhibitors (SSRI) |
| placebo | Placebo comparator | placebo arm Receives: Other: placedo; Drug: selective 5 - HT reuptake inhibitors (SSRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and week 8
Secondary outcomes (5)
Changes of Hamilton depressive scale (HAMD) from baseline to week 12
Range from 24-75, higher score indicates more severe symptoms
Measured: Week 0 and week 12.
the total scores of Hamilton depressive scale (HAMD)
Range from 24-75, higher score indicates more severe symptoms
Measured: Week 0, 2, 4, 6, 8, 12.
Hamilton Anxiety Scale(HAMA)
Range from 0-56, higher score indicates more severe symptoms
Measured: 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
Measured: 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
Measured: Week 0, 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start15 Jul 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be treated with sulforaphane or placebo for 12 weeks after ramdomization.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renrong Wu, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246905
- Sponsor's protocol ID
- 2019209
- Status last verified
- Aug 2020
- First submitted
- 6 Jan 2020
- Last updated
- 20 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adjunctive Sulforaphane for Depression: Study Protocol for a Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04246905
- Acronym / sponsor ID
- 2019209
- Conditions
- Depressive Disorder
- Keywords
- Sulforaphane, Depression, Fatigue, Cognition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 29 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be treated with sulforaphane or placebo for 12 weeks after ramdomization.
| Arm | Type | Receives |
|---|---|---|
| sulforaphane | Active comparator | Drug: sulforaphane, Drug: selective 5 - HT reuptake inhibitors (SSRI)sulforaphane treatment arm |
| placebo | Placebo comparator | Other: placedo, Drug: selective 5 - HT reuptake inhibitors (SSRI)placebo arm |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- treatment-resistant depression
- have known allergies, hypersensitivity, intolerance, or contraindications to SSRI or any of the trial preparations
- strong homicidal ideation/intent
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sulforaphaneTo examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment | Drug | sulforaphane |
| placedoTo examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment | Other | placebo |
| selective 5 - HT reuptake inhibitors (SSRI)To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment | Drug | placebo, sulforaphane |
Primary outcome
Change from baseline Montgomery-A° sberg Depression Rating Scale (MADRS) total score at week 8
Time frame: baseline and week 8
Range from 0-60, higher score indicates more severe symptoms
5 secondary outcomes
Changes of Hamilton depressive scale (HAMD) from baseline to week 12
Time frame: Week 0 and week 12.
the total scores of Hamilton depressive scale (HAMD)
Time frame: Week 0, 2, 4, 6, 8, 12.
Hamilton Anxiety Scale(HAMA)
Time frame: Week 0, 2, 4, 6, 8, 12.
The total score of clinical global impression-severty of illness (CGI-SI)
Time frame: Week 0, 2, 4, 6, 8, 12.
Change of MATRICS Consensus Cognitive Battery （MCCB）from baseline to week 12
Time frame: Week 0, 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2020.
Related trials for Depressive Disorder
Not yet recruiting
Expressive Arts Therapy in Major Depression: An RCT
Depression - Major Depressive Disorder
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
Recruiting
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression
Treatment Resistant Depression
Active, not recruiting
CET- REM (Correlating ECT Response to EEG Markers)
ECT, Treatment Resistant Depression
Active, not recruitingPhase 4
Neural Circuit Effects of Ketamine in Depression
Major Depressive Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Huang, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sulforaphane, placedo and selective 5 - HT reuptake inhibitors (SSRI) in people with Depressive Disorder, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renrong Wu, M.D. Ph.D (+8615874179855, wurenrong@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Montgomery-A° sberg Depression Rating Scale (MADRS) total score at week 8 (time frame: baseline and week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2020; AzTrials last refreshed its copy on 5 Nov 2026.