A 12-weeks Study to Evaluate Sulforaphane in the Treatment of Depression
Primary Purpose
Depressive Disorder
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
sulforaphane
placedo
selective 5 - HT reuptake inhibitors (SSRI)
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder focused on measuring Sulforaphane, Depression, Fatigue, Cognition
Eligibility Criteria
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
Sites / Locations
- Mental Health Institute of Second Xiangya Hospital,CSURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
sulforaphane
placebo
Arm Description
sulforaphane treatment arm
placebo arm
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes of Hamilton depressive scale (HAMD) from baseline to week 12
Range from 24-75, higher score indicates more severe symptoms
the total scores of Hamilton depressive scale (HAMD)
Range from 24-75, higher score indicates more severe symptoms
Hamilton Anxiety Scale(HAMA)
Range from 0-56, higher score indicates more severe symptoms
The total score of clinical global impression-severty of illness (CGI-SI)
Range from 0-7, higher score indicates more severe symptoms
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
Full Information
NCT ID
NCT04246905
First Posted
January 6, 2020
Last Updated
August 18, 2020
Sponsor
Central South University
1. Study Identification
Unique Protocol Identification Number
NCT04246905
Brief Title
A 12-weeks Study to Evaluate Sulforaphane in the Treatment of Depression
Official Title
Efficacy of Adjunctive Sulforaphane for Depression: Study Protocol for a Randomized, Double-blind, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
Sulforaphane, Depression, Fatigue, Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients will be treated with sulforaphane or placebo for 12 weeks after ramdomization.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants and researchers are blind to treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sulforaphane
Arm Type
Active Comparator
Arm Description
sulforaphane treatment arm
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo arm
Intervention Type
Drug
Intervention Name(s)
sulforaphane
Intervention Description
To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment
Intervention Type
Other
Intervention Name(s)
placedo
Intervention Description
To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment
Intervention Type
Drug
Intervention Name(s)
selective 5 - HT reuptake inhibitors (SSRI)
Intervention Description
To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment
Primary Outcome Measure Information:
Title
Change from baseline Montgomery-A° sberg Depression Rating Scale (MADRS) total score at week 8
Description
Range from 0-60, higher score indicates more severe symptoms
Time Frame
baseline and week 8
Secondary Outcome Measure Information:
Title
Changes of Hamilton depressive scale (HAMD) from baseline to week 12
Description
Range from 24-75, higher score indicates more severe symptoms
Time Frame
Week 0 and week 12.
Title
the total scores of Hamilton depressive scale (HAMD)
Description
Range from 24-75, higher score indicates more severe symptoms
Time Frame
Week 0, 2, 4, 6, 8, 12.
Title
Hamilton Anxiety Scale(HAMA)
Description
Range from 0-56, higher score indicates more severe symptoms
Time Frame
Week 0, 2, 4, 6, 8, 12.
Title
The total score of clinical global impression-severty of illness (CGI-SI)
Description
Range from 0-7, higher score indicates more severe symptoms
Time Frame
Week 0, 2, 4, 6, 8, 12.
Title
Change of MATRICS Consensus Cognitive Battery (MCCB)from baseline to week 12
Description
To evaluate the efficacy of adjunctive sulforaphane treatment in improving cognitive functions. Higher score indicates better cognition
Time Frame
Week 0, 12.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renrong Wu, M.D. Ph.D
Phone
+8615874179855
Email
wurenrong@csu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Huang, M.D.
Email
jinghuangserena001@csu.edu.cn
Facility Information:
Facility Name
Mental Health Institute of Second Xiangya Hospital,CSU
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renrong Wu, PhD
Phone
15874179855
Email
wurenrong2013@163.com
12. IPD Sharing Statement
Learn more about this trial
A 12-weeks Study to Evaluate Sulforaphane in the Treatment of Depression
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