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

• Sponsor: Central South University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04246905
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.5
• Patients Per Site Per Month: 5.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder	Drug: sulforaphane; Other: placedo; Drug: selective 5 - HT reuptake inhibitors (SSRI)	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Patients will be treated with sulforaphane or placebo for 12 weeks after ramdomization.Patients will be treated with sulforaphane or placebo for 12 weeks after ramdomization.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Participants and researchers are blind to treatment allocation (double-blind). An independent researcher developed the computer-generated randomization plan.
• Primary Purpose: Treatment
• Official Title: Efficacy of Adjunctive Sulforaphane for Depression: Study Protocol for a Randomized, Double-blind, Placebo-controlled Study
• Actual Study Start Date: Jul 15, 2020
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/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
Placebo Comparator: placebo placebo arm	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

Outcome Measures

Primary Outcome Measures

1. Change from baseline Montgomery-A° sberg Depression Rating Scale (MADRS) total score at week 8 [baseline and week 8]

   Range from 0-60, higher score indicates more severe symptoms

Secondary Outcome Measures

1. Changes of Hamilton depressive scale (HAMD) from baseline to week 12 [Week 0 and week 12.]

   Range from 24-75, higher score indicates more severe symptoms

2. the total scores of Hamilton depressive scale (HAMD) [Week 0, 2, 4, 6, 8, 12.]

   Range from 24-75, higher score indicates more severe symptoms

3. Hamilton Anxiety Scale(HAMA) [Week 0, 2, 4, 6, 8, 12.]

   Range from 0-56, higher score indicates more severe symptoms

4. The total score of clinical global impression-severty of illness (CGI-SI) [Week 0, 2, 4, 6, 8, 12.]

   Range from 0-7, higher score indicates more severe symptoms

5. Change of MATRICS Consensus Cognitive Battery （MCCB）from baseline to week 12 [Week 0, 12.]

   To evaluate the efficacy of adjunctive sulforaphane treatment in improving cognitive functions. Higher score indicates better cognition

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mental Health Institute of Second Xiangya Hospital,CSU	Changsha	Hunan	China	410011

Sponsors and Collaborators

• Central South University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Renrong Wu, Professor, Central South University
• ClinicalTrials.gov Identifier: NCT04246905
• Other Study ID Numbers: 2019209
• First Posted: Jan 29, 2020
• Last Update Posted: Aug 20, 2020
• Last Verified: Aug 1, 2020

• 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
• Keywords provided by Renrong Wu, Professor, Central South University: Sulforaphane; Depression; Fatigue; Cognition
• Additional relevant MeSH terms: Depression; Depressive Disorder; Sulforaphane

Study Results

No Results Posted as of Aug 20, 2020