Clinical trial NCT04246905: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Depressive Disorder
Keywords: Sulforaphane
Depression
Fatigue
Cognition
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be treated with sulforaphane or placebo for 12 weeks after ramdomization.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline Montgomery-A° sberg Depression Rating Scale (MADRS) total score at week 8
timeFrame: baseline and week 8
Secondary outcomes:
measure: Changes of Hamilton depressive scale (HAMD) from baseline to week 12
timeFrame: Week 0 and week 12.
measure: the total scores of Hamilton depressive scale (HAMD)
timeFrame: Week 0, 2, 4, 6, 8, 12.
measure: Hamilton Anxiety Scale(HAMA)
timeFrame: Week 0, 2, 4, 6, 8, 12.
measure: The total score of clinical global impression-severty of illness (CGI-SI)
timeFrame: Week 0, 2, 4, 6, 8, 12.
measure: Change of MATRICS Consensus Cognitive Battery （MCCB）from baseline to week 12
timeFrame: Week 0, 12.
Other outcomes:
Locations:
city: Changsha
country: China
facility: Mental Health Institute of Second Xiangya Hospital,CSU
state: Hunan
Study officials:
References: