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

NCT04246905 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 2019209
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder

Keywords

Sulforaphane; Depression; Fatigue; Cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes of Hamilton depressive scale (HAMD) from baseline to week 12

  Week 0 and week 12.

• the total scores of Hamilton depressive scale (HAMD)

  Week 0, 2, 4, 6, 8, 12.

• Hamilton Anxiety Scale(HAMA)

  Week 0, 2, 4, 6, 8, 12.

• The total score of clinical global impression-severty of illness (CGI-SI)

  Week 0, 2, 4, 6, 8, 12.

• Change of MATRICS Consensus Cognitive Battery （MCCB）from baseline to week 12

  Week 0, 12.

Study Arms (2)

sulforaphane

ACTIVE COMPARATOR

sulforaphane treatment arm

Drug: sulforaphane; Drug: selective 5 - HT reuptake inhibitors (SSRI)

placebo

PLACEBO COMPARATOR

placebo arm

Other: placedo; Drug: selective 5 - HT reuptake inhibitors (SSRI)

Interventions

sulforaphane DRUG

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

sulforaphane

placedo OTHER

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

placebo

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

placebo; sulforaphane

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• treatment-resistant depression
• have known allergies, hypersensitivity, intolerance, or contraindications to SSRI or any of the trial preparations
• strong homicidal ideation/intent
• pregnancy

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

Mental Health Institute of Second Xiangya Hospital,CSU

Changsha, Hunan, 410011, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Depression; Fatigue

Interventions

sulforaphane; Selective Serotonin Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Central Study Contacts

Renrong Wu, M.D. Ph.D

CONTACT

+8615874179855; wurenrong@csu.edu.cn

Jing Huang, M.D.

CONTACT

jinghuangserena001@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and researchers are blind to treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be treated with sulforaphane or placebo for 12 weeks after ramdomization.

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 29, 2020
• Study Start: July 15, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 20, 2020

Record last verified: 2020-08

Locations

CN (1)