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 Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410011
        • Recruiting
        • Mental Health Institute of Second Xiangya Hospital,CSU
        • Contact:

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
Drug: 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
Other: placedo
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
Drug: sulforaphane
To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment
Drug: 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

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

Central South University

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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