- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04246905
A 12-weeks Study to Evaluate Sulforaphane in the Treatment of Depression
August 18, 2020 updated by: Renrong Wu, Central South University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Renrong Wu, M.D. Ph.D
- Phone Number: +8615874179855
- Email: wurenrong@csu.edu.cn
Study Contact Backup
- Name: Jing Huang, M.D.
- Email: jinghuangserena001@csu.edu.cn
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410011
- Recruiting
- Mental Health Institute of Second Xiangya Hospital,CSU
-
Contact:
- Renrong Wu, PhD
- Phone Number: 15874179855
- Email: wurenrong2013@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: placebo
placebo arm
|
To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment
To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment
|
Active Comparator: sulforaphane
sulforaphane treatment arm
|
To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment
To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline and week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of Hamilton depressive scale (HAMD) from baseline to week 12
Time Frame: Week 0 and 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)
Time Frame: Week 0, 2, 4, 6, 8, 12.
|
Range from 24-75, higher score indicates more severe symptoms
|
Week 0, 2, 4, 6, 8, 12.
|
Hamilton Anxiety Scale(HAMA)
Time Frame: Week 0, 2, 4, 6, 8, 12.
|
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)
Time Frame: Week 0, 2, 4, 6, 8, 12.
|
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
Time Frame: Week 0, 12.
|
To evaluate the efficacy of adjunctive sulforaphane treatment in improving cognitive functions.
Higher score indicates better cognition
|
Week 0, 12.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2020
Primary Completion (Anticipated)
December 31, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
January 6, 2020
First Submitted That Met QC Criteria
January 28, 2020
First Posted (Actual)
January 29, 2020
Study Record Updates
Last Update Posted (Actual)
August 20, 2020
Last Update Submitted That Met QC Criteria
August 18, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019209
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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