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The efficacy and safety of sulforaphane as an adjuvant in the treatment of bipolar depressive disorder: study protocol for a randomized, double-blinded, placebo-controlled, parallel-group clinical trial

The efficacy and safety of sulforaphane as an adjuvant in the treatment of bipolar depressive disorder: study protocol for a randomized, double-blinded, placebo-controlled, parallel-group clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000028706
Enrollment
Unknown
Registered
2020-01-01
Start date
2020-03-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bipolar disorder

Interventions

Group A:Sulforaphane (ZHIYINGUOSU, Shenzhen Fushan Biotech Co., Ltd.)
Group B:placebo

Sponsors

The First Affiliated Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) males or females aged 16 to 65 years old; (2) agree to participate in the research and sign the informed consent form; (3) the subjects biological parents are Han; (4) diagnosed with bipolar depressive disorder according to the DSM-IV (the fourth Edition of Diagnostic and Statistical Manual of Mental Disorders) diagnostic criteria; (5) score more than or equal to 17 points on the Hamilton Depression Scale (HAMD) at screening and baseline period; (6) score less than or equal to 5 points on the Young Mania Rating Scale (YMRS) at screening and baseline period; (7) no taking any drug treatment or no receiving antidepressant treatment in the last 1 month; (8) take drugs by oneself during the study period, or have a regular helper to help with the medication.

Exclusion criteria

Exclusion criteria: (1) diagnosed with other spectrum disorders according to the DSM-IV diagnostic criteria; (2) mental disorder caused by substance abuse, or serious physical diseases; (3) received antibiotics within 1 month before enrollment due to respiratory tract, urinary tract, the digestive system infection; (4) subjects with a history of attempted suicide, or currently at high suicide risk, or with suicide behavior/attempt, or scoring more than or equal to 3 points on the 10th clause of Montgomery Asberg Depression Rating Scale (MADRS); (5) unwilling to take the medicine; (6) known pregnancy, lactation, or pregnant planning; (7) the subjects with contraindications of quetiapine or have used quetiapine but have poor efficacy; (8) allergic to broccoli; (9) Received electroconvulsive therapy within one month.

Design outcomes

Primary

MeasureTime frame
17 items of Hamilton depression scale;Montgomery depression scale;

Secondary

MeasureTime frame
Hamilton anxiety scale;Depression symptom self-rating scale;Young Mania Rating Scale;inflammatory factor;neurocognitive function assessment;

Countries

China

Contacts

Public ContactShaohua Hu

The First Affiliated Hospital, Zhejiang University School of Medicine

dorhushaohua@zju.edu.cn+86 0571-87235995

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 18, 2026