A 12-weeks Study to Evaluate Sulforaphane in the Treatment of Depression

Depressive Disorder Clinical Trial

Official title:

Efficacy of Adjunctive Sulforaphane for Depression: Study Protocol for a Randomized, Double-blind, Placebo-controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04246905
• Other study ID #: 2019209
• Status: Recruiting
• Phase: Phase 2
• Start date: July 15, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: August 2020
• Source: Central South University
• Contact: Renrong Wu, M.D. Ph.D
• Phone: +8615874179855
• Email: wurenrong[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• sulforaphane
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

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

Locations

Country	Name	City	State
China	Mental Health Institute of Second Xiangya Hospital,CSU	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.
Secondary	the total scores of Hamilton depressive scale (HAMD)	Range from 24-75, higher score indicates more severe symptoms	Week 0, 2, 4, 6, 8, 12.
Secondary	Hamilton Anxiety Scale(HAMA)	Range from 0-56, higher score indicates more severe symptoms	Week 0, 2, 4, 6, 8, 12.
Secondary	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.
Secondary	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.