An Exploratory Study on Monoclonal Antibody (SIF001) for the Treatment of Treatment-Resistant Depression

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500110093

Enrollment

Unknown

Registered

2025-09-30

Start date

2025-09-30

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

Treatment-Resistant Depression (TRD)

Interventions

Treatment group:Monoclonal Antibody SIF001

Eligibility

Sex/Gender

All

Age

10 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with treatment-resistant depression; 2. Age >=10 years and =50 kg, body mass index (BMI) between 18 and 35.

Exclusion criteria

Exclusion criteria: 1. Females who are pregnant, planning to become pregnant within the next year, or are currently breastfeeding; 2. Clinically significant or unstable medical conditions (including alcohol and/or substance abuse) or progressive central nervous system diseases; 3. Severe systemic diseases affecting the heart, lungs, liver, kidneys, or other major organs; 4. Subjects judged by the investigator to have poor compliance or to be otherwise unsuitable for participation in the clinical trial.

Design outcomes

Primary

Measure	Time frame
Hamilton Depression Rating Scale (HAMD);Safety Parameters (collection and analysis of: biochemical blood tests, complete blood count, glycated hemoglobin, urinalysis, and vital signs [blood pressure, respiration rate, body temperature, and pulse]).;	—

Countries

China

Contacts

Public ContactWang Jincheng

First Hospital of Hebei Medical University

wjc81125@126.com+86 133 1321 2690

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026